[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-insufficiency":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,42,81,116,143,175,203,231,255,267,298,323,357,388,423,445,473,495,525,553,580,606,629,659,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053631","thoracoabdominal-asynchrony-and-respiratory-distress-100053631",false,"NCT04626154","Thoracoabdominal Asynchrony and Respiratory Distress","Validation of a Non-Invasive Device for Thoracoabdominal Asynchrony-Based Respiratory Effort Assessment in Pediatric Patients","Inclusion Criteria:\n\n1. patients 28-days to 17-years of age\n2. who have respiratory distress and those who do not have respiratory distress\n\nExclusion Criteria:\n\nHardware, clinical care, or dermal injury that would preclude the application of TAA device","ALL","28 Days","17 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions.\n\nAIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.",[28],"Respiratory Insufficiency","RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2020-10-16",{"date":37,"type":22},"2029-06-01",{"name":39,"class":40},"Massachusetts General Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":66,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100598472","phase-2-a-clinical-trial-of-early-ventilation-in-amyotrophic-lateral-sclerosis-event-als-100598472","NCT07071935","A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","A Pilot Randomized Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","EVENT ALS","Inclusion Criteria:\n\n* Diagnosed with ALS using the Gold Coast Criteria within the last 6 months\n* Age ≥18 years\n* Willingness and ability to participate in study procedures\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Current or prior or recommended\u002Fprescribed use of NIV including:\n\n   i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or \"CPAP\" therapy\n2. Forced vital capacity \\\u003C50% of predicted normal\n3. Maximal inspiratory pressure \\> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)\n4. Chronic use of supplemental oxygen at any part of the day\n5. Enrollment in hospice\n6. Current tracheostomy\n7. Prior history of sleep apnea where non-invasive ventilation was used or recommended\n8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks\n9. Coughing up blood\n10. Myocardial infarction in the previous 4 weeks\n11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)\n12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician","18 Years",{"count":52,"type":22},48,[54],"PHASE2","Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time.\n\nThe investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day.\n\nIn this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study.\n\nThe purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.",[57,58,59,60,28,61,62,63,64,65],"Amyotrophic Lateral Sclerosis (ALS)","Chronic Respiratory Failure","Neuromuscular Disease Patients","Neuromuscular Disease","Respiratory Insufficiency Requiring Mechanical Ventilation","Positive Pressure Ventilation","Non-invasive Ventilation","Non-invasive Ventilation Support","Non-invasive Ventilatory Support",[67,68,69,70],"chronic respiratory failure","chronic neuromuscular respiratory failure","non-invasive ventilation","amyotrophic lateral sclerosis","2026-06-25",{"date":73,"type":33},"2026-06-26",{"date":75,"type":33},"2026-06-11",{"date":77,"type":22},"2029-05",{"name":79,"class":40},"University of Pennsylvania",3,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100638294","abdominal-stimulation-to-improve-cough-after-spinal-cord-injury-100638294","NCT07626931","Abdominal Stimulation to Improve Cough After Spinal Cord Injury","Abdominal Function Electrical Stimulation to Improve Cough Peak Flow After Spinal Cord Injury: A Multicenter Randomized Controlled Trial","COUFES","Inclusion Criteria:\n\n1. Adults (≥ 22 years of age) admitted to rehabilitation with a new SCI.\n2. New non-progressive SCI occurring in the past 3 to 8 weeks.\n3. Neurological level of injury of C1-T5.\n4. American Spinal Injuries Association Impairment Scale A to C.\n5. CPF of \\\u003C160 L\u002Fmin (Note: A CPF of \\\u003C270 L\u002Fmin has been shown to be associated with decreased secretion clearance and increased respiratory complications, while a CPF of \\\u003C160 L\u002Fmin has been shown to lead to an ineffective cough).\n6. Not dependent on mechanical ventilation (people dependent on mechanical ventilation are at greatly increased risk of respiratory complications and are excluded due to this heterogeneity).\n7. Able to sit upright.\n8. Expected to remain in rehabilitation for at least another 3 weeks.\n\nExclusion Criteria:\n\n1. Respiratory complications in previous 24 hours (screening out iatrogenic complications).\n2. Chronic respiratory disease.\n3. No contraction of the abdominal wall muscles in response to abdominal NMES.\n4. Open abdominal surgery ≤ 4 weeks prior to enrollment.\n5. Have yet to undergo spinal surgery to stabilize injury, where required.\n6. Body mass index \\>40 kg\u002Fm2.\n7. Pacemaker (external or internal) or implanted electronic device (e.g., a defibrillator).\n8. Known or expected to be pregnant.\n9. Placed on a palliative\u002Fsupportive care only pathway.\n10. Receiving any of the following as standard of care:\n\n    * Abdominal FES\n    * Inspiratory or Expiratory muscle training\n    * Transcutaneous or implanted thoracolumbar spinal stimulation\n11. Participating in any of the following:\n\n    * A study with the same or similar primary endpoint\n    * A study investigating electrical stimulation or respiratory muscle therapy\n    * Any study in which the investigator determines may interfere with the results of this study\n12. Unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits including facial or dental trauma.\n13. Any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.\n14. Unable to provide informed consent.\n15. Unwilling to provide informed consent.","22 Years",{"count":91,"type":22},150,[25],"The goal of this clinical trial is to learn if abdominal functional electrical stimulation (FES) using the VentFree Respiratory Muscle Stimulator improves cough strength in adults with a new spinal cord injury (SCI). It will also learn about the safety of abdominal FES in this population. The main questions it aims to answer are:\n\nDoes abdominal FES improve cough peak flow (a measure of cough strength) compared to cough training alone? Does abdominal FES reduce the number of respiratory complications (such as pneumonia or atelectasis)? What medical problems do participants have when receiving abdominal FES?\n\nResearchers will compare abdominal FES (active treatment) to supervised cough training without stimulation (control) to see if abdominal FES improves cough function after spinal cord injury.\n\nParticipants will:\n\nReceive abdominal FES or perform supervised cough training 5 days per week for up to 6 weeks during inpatient rehabilitation Have cough strength and breathing function measured at the start of the study and every week during treatment Complete quality of life and bowel function questionnaires at multiple time points Have a follow-up visit or phone call 4 weeks after completing treatment",[95,28],"Spinal Cord Injuries (SCI)",[97,98,99,100,101,102,103,104],"Spinal Cord Injuries","Functional Electrical Stimulation","Cough Peak Flow","Respiratory Muscles","Abdominal Muscles","Tetraplegia","Rehabilitation","Muscle Strength","NOT_YET_RECRUITING","2026-05-29",{"date":108,"type":33},"2026-06-04",{"date":110,"type":22},"2026-08",{"date":112,"type":22},"2028-06",{"name":114,"class":115},"Liberate Medical","INDUSTRY",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":41},"100637998","validation-of-the-turkish-version-of-the-s3-niv-questionnaire-100637998","NCT07610122","Validation of the Turkish Version of the S3-NIV Questionnaire","Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)","Inclusion Criteria:\n\n* Diagnosed with chronic respiratory failure requiring home non-invasive ventilation (NIV).\n* Using a home NIV device for at least 3 months.\n* Being in a clinically stable phase (no exacerbation or hospitalization in the last 1 month).\n* Able to understand and answer the questionnaire.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Acute respiratory failure or clinical instability.\n* Severe cognitive impairment or psychiatric disorders preventing reliable communication.\n* Active malignancy or terminal illness with a short life expectancy.\n* Refusal to provide informed consent.",{"count":124,"type":22},120,"OBSERVATIONAL","This study aims to evaluate the psychometric properties, including reliability and validity, of the Turkish version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV). The S3-NIV is a specific tool designed to assess difficulties and compliance in patients receiving home non-invasive ventilation. A total of 120 stable patients using home NIV for at least 3 months will be enrolled across multiple centers.",[28,58],[129,130,131,132,133],"Non-Invasive Ventilation","Validation","Questionnaire","Reliability","S3-NIV","2026-05-27",{"date":136,"type":33},"2026-05-28",{"date":138,"type":22},"2026-05-21",{"date":140,"type":22},"2026-12-30",{"name":142,"class":40},"Istanbul Saglik Bilimleri University",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":160,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":41},"100640072","optimal-peep-for-postoperative-oxygenation-and-lung-aeration-ultrasvent-2-100640072","NCT07613177","Optimal PEEP for Postoperative Oxygenation and Lung Aeration (ULTRASVENT-2)","Effect of Positive End-Expiratory Pressure (PEEP) Level on Postoperative Oxygenation and Lung Aeration Assessed by Lung Ultrasound Monitoring: A Multicenter Randomized Controlled Trial (ULTRASVENT-2)","ULTRASVENT-2","Inclusion Criteria:\n\n* Age greater than or equal to 18 years.\n* Planned elective non-cardiac and non-thoracic surgical intervention requiring general anesthesia with mechanical ventilation.\n* Airway protection utilizing an endotracheal tube.\n* Assignment to one of the four specific surgical strata: non-abdominal, major open abdominal, major laparoscopic abdominal, or low-trauma laparoscopic surgery.\n* Baseline lung ultrasound showing no pathological findings, corresponding to a total preoperative LUS score of 0.\n* Technical feasibility of performing a postoperative lung ultrasound within the first 2 hours after the completion of surgery.\n* Signed written informed consent to participate in the clinical trial.\n\nExclusion Criteria:\n\n* Planned cardiac or thoracic surgery (e.g., coronary artery bypass grafting, valve replacement, heart transplantation, lung resection, esophageal surgery).\n* Pneumothorax diagnosed before or during the surgical procedure.\n* Inability to adequately visualize the target dorsal-basal lung zones by ultrasound due to physical limitations (e.g., morbid obesity, massive surgical dressings, anatomical anomalies, or dermatological lesions in the scanning area).\n* Presence of hydrothorax detected on the baseline preoperative ultrasound.\n* Confirmed perioperative aspiration of gastric contents or other foreign material.\n* Any pathological changes identified during the baseline ultrasound of the dorsal-basal lung regions (a total preoperative LUS score greater than 0).\n* Requirement for massive blood transfusion during the surgery, defined according to local institutional criteria.\n* Surgical interventions directly involving or violating the diaphragm.\n* Expected inability to conduct reliable postoperative clinical and ultrasound assessments (e.g., need for deep sedation preventing wakefulness and contact, or planned transfer to another facility).",{"count":152,"type":22},360,[25],"The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2\u002FFiO2 (S\u002FF ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation.\n\nPatients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.",[156,28,157,158,159],"Postoperative Complications","Pulmonary Atelectasis","Positive-End Expiratory Pressure","Hypoxemia",[161,162,163,164,165],"Lung ultrasound","S\u002FF ratio","Perioperative lung protection","Laparoscopic surgery","Open laparotomy","2026-05-23",{"date":106,"type":33},{"date":169,"type":22},"2026-07-01",{"date":171,"type":22},"2026-12-20",{"name":173,"class":174},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":41},"100567994","inhaled-nitric-oxide-in-severe-obesity-100567994","NCT06675435","Inhaled Nitric Oxide in Severe Obesity","The Effect of Inhaled Nitric Oxide on Intrapulmonary Shunt in Acutely Hypoxemic Patients With Severe Obesity","For participants with acute hypoxemic respiratory failure\n\nInclusion Criteria:\n\n* Acute hypoxemic respiratory failure, defined as persistent hypoxemia (PaO2\u002FFiO2 ≤ 300 mmHg or SpO2\u002FFiO2 ≤ 315) and on invasive mechanical ventilation for \\\u003C 72 hours\n* Presence of an arterial and central venous catheter (for blood gas measurement)\n* Admitted to a participating MGH ICU\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or known active breastfeeding\n* Prisoner or Incarceration\n* Inability or unwillingness of subject or legal surrogate\u002Frepresentative to give written informed consent\n* Use of inhaled or oral pulmonary vasodilatory therapy within the 24 hours preceding study enrollment\n* Contraindication to inhaled NO\n\n  * Baseline Methemoglobin ≥ 3%\n  * Known left ventricle ejection fraction \\\u003C 20%\n  * Known history of G6PD deficiency or cytochrome issues\n  * Prior adverse reaction to inhaled nitric oxide\n* Presence of pneumothorax or acute pulmonary embolism\n* Chronic hypoxemia requiring home supplemental non-invasive oxygen (nasal cannula or positive pressure ventilation) or home mechanical ventilation\n* Chronic pulmonary vascular disease on home chemical vasodilator support (e.g., sildenafil)\n* History of lung resection or transplant\n* Hemodynamic instability at the time of potential study enrollment defined as:\n\n  * Persistent systolic blood pressure \\\u003C 90 mmHg or \\>180 mmHg despite the use of vasopressor or vasodilators or\n  * Requiring an increment in inotropic-vasopressors over the past two hours just before enrollment: more than 15 mcg\u002Fmin for norepinephrine and dopamine, more than 10 mcg\u002Fmin in epinephrine; and more than 50 mcg\u002F min for phenylephrine.\n\nEIT assessments of lung perfusion will only be performed in participants who are already receiving neuromuscular blocking agents (e.g., cisatracurium) at the time of study enrollment. EIT assessments of lung perfusion will not be performed in participants who have the following contraindications to EIT perfusion monitoring:\n\n* Hypernatremia (serum sodium \\> 150 mEq\u002FL)\n* Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator\n\nFor controls without acute hypoxemic respiratory failure\n\nInclusion Criteria:\n\n* Receiving invasive mechanical ventilation and do not have a diagnosis of acute hypoxemic respiratory failure (PaO2\u002FFiO2 \\> 300 mmHg or SpO2\u002FFiO2\\> 315)\n* Presence of an arterial catheter\n* Admitted to a participating MGH ICU\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or known active breastfeeding\n* Prisoner or Incarceration\n* Inability or unwillingness of subject or legal surrogate\u002Frepresentative to give written informed consent",{"count":183,"type":22},60,[25],"The goal of this clinical trial is to learn about the effects of inhaled nitric oxide on oxygenation and lung perfusion in participants with severe obesity who have acute hypoxemic respiratory failure and are on mechanical ventilation\n\nThe main questions it aims to answer are:\n\n1. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on oxygenation in participants with severe obesity compared to participants with normal body weight.\n2. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on lung perfusion and heart function in participants with severe obesity compared to participants with normal body weight.\n3. In acute hypoxemic respiratory failure, does severe obesity impact nitric oxide signaling pathways?\n\nParticipants with acute hypoxemic respiratory failure will be exposed to inhaled nitric oxide (20 ppm) while being clinically monitored.",[187,28,188,189],"Obesity","Hypoxemic Respiratory Failure","Nitric Oxide",[191,192,193,194],"severe obesity","acute hypoxemic respiratory failure","intrapulmonary shunt","inhaled nitric oxide","2026-05-19",{"date":197,"type":33},"2026-05-20",{"date":199,"type":22},"2026-10",{"date":201,"type":22},"2028-12",{"name":39,"class":40},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":41},"100636871","combined-predictive-value-of-rsbi-and-cally-index-in-predicting-weaning-success-in-icu-patients-100636871","NCT07571317","Combined Predictive Value of RSBI and CALLY Index in Predicting Weaning Success in ICU Patients","Combined Predictive Value of Rapid Shallow Breathing Index (RSBI) and CRP-Albumin-Lymphocyte (CALLY) Indices in Predicting the Success of Weaning From Mechanical Ventilation in Intensive Care Patients: A Prospective Observational Study","Inclusion Criteria:\n\n* Patients aged 18 years and older\n* Patients who have received invasive mechanical ventilation for at least 24 hours in the general intensive care unit.\n\nPatients who meet standard clinical weaning criteria (e.g., hemodynamic stability with minimal or no vasopressor support, adequate cough reflex, absence of excessive airway secretions).\n\nPatients deemed ready for a Spontaneous Breathing Trial by the attending physician.\n\nExclusion Criteria:\n\n* Patients under the age of 18.\n* Patients with a known or detected pregnancy.\n* Patients with a diagnosis of malignancy.\n* Patients with neuromuscular diseases that could impair respiratory effort or muscle strength assessments (e.g., Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Guillain-Barré syndrome).",{"count":211,"type":22},105,"The primary objective of this prospective observational study is to evaluate the effectiveness of combining the Rapid Shallow Breathing Index (RSBI) and CRP-Albumin-Lymphocyte (CALLY) index to predict weaning success in adult patients within the intensive care unit. While weaning from mechanical ventilation is a critical clinical step, existing physiological metrics like RSBI do not fully capture a patient's inflammatory or nutritional status. This research introduces the CALLY index calculated as the ratio of the patient's immuno-nutritional reserve (Albumin and Lymphocytes) to systemic inflammation (CRP) as a complementary metabolic marker. By tracking approximately 105 participants at Basaksehir Cam and Sakura City Hospital, the study monitors weaning success over both a 48 hour and a 7 day period to identify both immediate and late phase extubation failures. The ultimate goal is to provide a more holistic prediction model that potentially reduces re-intubation rates and improves clinical outcomes by accurately identifying the optimal time for ventilator removal.",[214,28,215,216],"Critical Illness","Ventilator Weaning","Weaning Failure of Mechanical Ventilation",[218,219,220,221],"mechanical ventilation","ventilator weaning","Systemic Inflammation","CRP-Albumin-Lymphocyte Ratio","2026-05-06",{"date":224,"type":33},"2026-05-11",{"date":226,"type":22},"2026-05-04",{"date":228,"type":22},"2026-07-31",{"name":230,"class":40},"Istanbul University - Cerrahpasa",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100473127","platform-of-randomized-adaptive-clinical-trials-in-critical-illness-100473127","NCT05440851","Platform of Randomized Adaptive Clinical Trials in Critical Illness","PRACTICAL","PRACTICAL Platform Inclusion Criteria:\n\n1. Acute hypoxemic respiratory failure meeting all of the following criteria;\n\n   1. New or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support\n   2. Receiving any of the following types of oxygen or respiratory support for at least 4 hours prior to the time of randomization; supplemental oxygen at 10 L\u002Fmin or higher, high flow nasal oxygen (at any flow rate), invasive ventilator support, extra-corporeal life support (ECLS), or non-invasive ventilator support\n   3. Minimum FiO2 ≥ 0.40 (for venturi mask, high flow nasal cannula, or invasive or non-invasive ventilation) or oxygen flow rate ≥10 L\u002Fmin on face mask for at least 4 hours at the time of evaluation for eligibility unless already on extra-corporeal life support\n2. Age ≥ 18 years\n3. Hypoxemia not primarily attributable to acute heart failure, fluid overload, or pulmonary embolism (PE)\n\nPRACTICAL Platform Exclusion Criteria:\n\n1. Extubation is planned or anticipated on the day of screening\n2. ICU discharged is planned or anticipated on the day of screening\n3. If the patient is moribund and deemed unlikely to survive 24 hours (as determined by the clinical team)\n4. If the patient is being transitioned to a fully palliative philosophy of care\n\nEXPAND-ECLS Domain Inclusion Criteria:\n\n1. Receiving invasive Endotracheal mechanical ventilation for ≤ 72 hours.5 days\n2. Early Moderate-severe hypoxemic respiratory failure with a PaO2\u002FFiO2≤150200 mmHg for at least 6 hours\n\nEXPAND-ECLS Domain Exclusion Criteria:\n\n1. Patients over 70 years of age.\n2. Currently receiving any form of ECLS (e.g., Venovenous, venoarterial, or hybrid configuration).\n3. Chronic hypercapnic respiratory failure defined as PaCO2 \\> 60 mmHg in the outpatient setting.\n4. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP\u002FBiPAP used solely for sleep-disordered breathing.\n5. Actual body weight exceeding 1 kg per centimeter of height.\n6. More than 48 hours have passed since meeting inclusion criteria.\n7. Severe hypoxemia with PaO2\u002FFiO2 \\\u003C 80mmHg for \\> 6 hours at time of screening.\n8. Severe hypercapnic respiratory failure with pH \\\u003C 7.25 and PaCO2 \\> 60 mmHg for \\> 6 hours at time of screening.\n9. Expected mechanical ventilation duration \\\u003C 48 hours at time of screening.\n10. Confirmed diffuse alveolar hemorrhage from vasculitis.\n11. Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis).\n12. Previous hypersensitivity\u002Fanaphylactic reaction to heparin or heparin-induced thrombocytopenia\n13. Neurologic conditions at risk for or undergoing treatment for intracranial hypertension\n14. Underlying illness with life expectancy \\\u003C 1 year\n15. Pregnancy (due to unknown effects of PaCO2 changes on placental blood flow)\n16. Respiratory failure known or suspected to be caused by COVID-19.\n\nIMV Domain Inclusion Criteria:\n\n1. Intubated patients, not on ECLS, with low normalized respiratory elastance (\\\u003C2.5 cm H2O\u002F(ml\u002Fkg predicted body weight)) at the time of eligibility assessment OR\n2. Intubated patients, not on ECLS, with high normalized respiratory system elastance (≥2.5 cm H2O\u002F(ml\u002Fkg predicted body weight)) at the time of eligibility assessment OR\n3. FOR STUDY SITES PARTICIPATING IN THE LDPVS INTERVENTION: Patient is on ECLS at the time of eligibility assessment. Note: Patients in this state are only eligible for the LPV or LDPVS intervention\n4. FOR STUDY SITES PARTICPATING IN THE EIT INTERVENTION: PaO2\u002FFiO2 (if available) \\\u003C 200 mm Hg at randomization. If PaO2\u002FFiO2 has not been measured, SpO2 = 97% on FiO2 =60%.\n\nIMV Domain Exclusion Criteria:\n\n1. PaO2\u002FFiO2 \\>300 mm Hg or (S\u002FF \\>250, if PaO2\u002FFiO2 has not been measured) at the time of randomization\n2. Chronic hypercapnic respiratory failure defined as PaCO2\\>60mmHg in the outpatient setting\n3. Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not including nocturnal CPAP applied by nasal or face mask or home tracheotomy if not ventilated\n4. Severe hypoxemia with PaO2\u002FFiO2\\\u003C80mmHg for \\>6 consecutive hours at the time of randomization\n5. Severe hypercapnic respiratory failure with pH\\\u003C7.25 and PaCO2\\>60mmHg for \\>6 consecutive hours at the time of randomization\n6. Anticipated duration of mechanical ventilation is \\\u003C48 hours from the time of screening\n7. Duration of mechanical ventilation during current ICU admission is \\>72 hours\n8. Previously diagnosed neuromuscular disorder\n9. Current diagnosis of severe acute brain injury (e.g. ischemic or hemorrhagic stroke, traumatic brain injury) with Glasgow Coma Scale ≤ 8\n10. Baseline weight prior to or at hospital admission less than 35 kilograms\n11. Receiving extracorporeal life support without continuous invasive mechanical ventilatory support\n\nCORT-E2 Domain Early Cohort Inclusion Criteria\n\n1. Within 72 hours of admission to an ICU\n2. New unilateral or bilateral airspace disease\n\nCORT-E2 Domain Early Domain Exclusion Criteria\n\n1. Receiving only low flow oxygen therapy less than or equal to 15L\u002Fmin\n2. Corticosteroid use during the 14 days prior to screening\n3. Existing indication for corticosteroids\n4. High suspicion for\u002For confirmed COVID infection\n5. Acute traumatic brain injury during the index hospital admission\n6. Allergy to dexamethasone\n\nCORT-E2 Domain Extended Cohort Inclusion Criteria\n\n1. Are admitted to an ICU\n2. Have already received 10 days of corticosteroid specifically for acute respiratory failure, this will include patients: (a) randomized to corticosteroid arm in Early Cohort, (b) patients with COVID receiving corticosteroids as standard of care , (c) and others who have received corticosteroids for AHRF\n3. Ongoing AHRF requiring HFNC, NIV (continuous positive airway pressure \\[CPAP\\] or bilevel) or invasive ventilation\n\nCORT-E2 Domain Extended Cohort Exclusion Criteria\n\n1. An alternate indication for ongoing corticosteroids\n2. Acute traumatic brain injury this hospital admission\n\nFLUDRO Domain Inclusion Criteria 1. Within 72 hours of admission to an ICU\n\nFLUDRO Domain Exclusion Criteria\n\n1. Known hypersensitivity to fludrocortisone\n2. An inability to receive fludrocortisone due to lack of enteral access\n3. An indication to prescribe fludrocortisone for a reason that is unrelated to a current episode of pneumonia or acute respiratory failure, such as Addison's disease\n4. Belief of the treating clinical team that study participation would not be in the best interest of the patient\n\nFAST-3 Domain Inclusion Criteria (must meet all 3 of the following)\n\n1. Patient is in a PRACTICAL eligible platform state and requires advanced respiratory support (ARS) defined as one of the following:\n\n   a. Invasive mechanical ventilation with FiO2 \\> 40% b. Non-Invasive Ventilation (\\> 4 hours consecutively with FiO2 \\> 40%) defined as: i. CPAP or BiPAP (any settings or interface) ii. HFNC (flow \\> 40 liter per minute)\n2. PaO2\u002FFiO2 \\\u003C 300 mm Hg or SpO2\u002FFiO2 \\\u003C 315 (if PaO2\u002FFiO2 unavailable due to lack of arterial blood gas at the time of screening). For SpO2\u002FFiO2, criteria are SpO2 ≤ 97% on FiO2 ≥ 40% on both of the 2 hours immediately preceding eligibility assessment. If an arterial blood gas can be obtained, then a PaO2\u002FFiO2 ratio is preferable.\n3. Patient commenced advanced respiratory support \\\u003C 48 hours prior to randomization.\n\nFAST-3 Domain Exclusion Criteria\n\n1. Patient commenced advanced respiratory support \\> 48 hours to time of randomization.\n2. Known history of severe chronic pulmonary disease e.g., pre-infection requirement for home oxygen therapy or presence of chronic hypercapnia (PaCO2 \\> 60 mmHg); mild - moderate disease is still eligible in the absence of chronic hypercapnia or need for chronic oxygen therapy.\n3. Currently enrolled in another trial studying investigational anti-inflammatory therapy, excluding established treatments used in clinical practice such as corticosteroids.\n4. Known allergy to furosemide or sulfonamide drugs. If the patient is allergic to sulfonamide drugs but has received in the past or is currently receiving furosemide without incident, they can be enrolled since cross-reactivity between furosemide and sulfonamide agents is rare.\n\nESCAPE Domain Inclusion Criteria\n\n1. Patients with severe AHRF who have an underlying immunocompromised condition\n2. Within 48 hours of fulfilling the AHRF inclusion criteria as well as PaO2\u002FFiO2 \\\u003C300 or a SaO2\u002FFiO2 \\\u003C 315 on non-invasive respiratory support (venturi mask, non-invasive ventilation or high flow nasal oxygen as per the FiO2 requirements above) or invasive ventilation.\n\nPatients may be enrolled from the wards or ICU.\n\nImmunocompromised patients include:\n\n1. Any patients requiring long term (\\>30 days) corticosteroids (\\>20 mg\u002Fday),\n2. Any patients receiving non-corticosteroid immunosuppressive medications within the prior 3 months,\n3. Acquired or inherited immunodeficiency syndrome,\n4. Recipients of solid organ transplant,\n5. Active hematologic malignancy (diagnosis or receiving treatment within prior 6 months),\n6. Active solid tumor (diagnosis or receiving treatment within the prior 6 months) or\n7. Any patients who have undergone allogeneic or autologous hematopoietic cell transplant in the prior 6 months (HCT).\n\n   ESCAPE Domain Exclusion Criteria\n   1. Patients whom are deemed palliative.\n\n   WAVEFORM Domain Inclusion Criteria\n\n   1\\. Patient is intubated at the time of eligibility assessment.\n\n   WAVEFORM Domain Exclusion Criteria\n   1. PaO2\u002FFiO2 \\>300 mm Hg or (S\u002FF \\>250, if PaO2\u002FFiO2 has not been measured) at the time of eligibility assessment.\n   2. Duration of mechanical ventilation during current ICU admission is ≥72 hours.\n   3. Receiving ECLS without continuous invasive mechanical ventilatory support.\n\n   IMV-ECLS Domain Inclusion Criteria\n\n   1\\. Patients with AHRF (as defined in platform inclusion criteria #1 above) who have been consented for cannulation for VV-ECLS or who have been initiated on VV-ECLS within 6 hours at the time of randomization\n\n   IMV-ECLS Domain Exclusion Criteria 1. Patients receiving ECLS for the primary intention of extracorporeal CO2 removal 2. Patients expected to be liberated from ECLS within \\\u003C24 hours 3. History of recent pneumothorax or pneumomediastinum (\\\u003C3 months at the time of eligibility assessment\u002Frandomization) 4. Patients receiving ECLS for the primary intention of bridge to lung transplantation (at the time of eligibility assessment\u002Frandomization)\n\n   IMPROV Domain Inclusion Criteria\n   1. Patients receiving invasive mechanical ventilation for AHRF as defined by the PRACTICAL platform trial criteria above.\n   2. Within 7 calendar days of intubation\n\n   IMPROV Domain Exclusion Criteria\n   1. Patient is expected to be liberated from mechanical ventilation within 24 hours\n   2. Known or suspected chronic hypercapnic respiratory failure defined as PaCO2\\>60mmHg in the outpatient setting\n   3. Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not including nocturnal CPAP applied by nasal or face mask or home tracheotomy if not ventilated\n   4. Known pneumothorax or pneumomediastinum without chest tube placement sustained during current ICU admission\\* (re-confirm immediately prior to randomization)\n   5. Patient is admitted primarily for acute brain injury (stroke, traumatic brain injury, etc.)\n   6. Previously diagnosed chronic neuromuscular disorder\n   7. Patient has an implantable cardiac defibrillator or pacemaker\n   8. Planned to be transferred to another hospital before ICU discharge\n   9. Already receiving a regimen of inspiratory muscle training using external resistive device or diaphragm neurostimulation",{"count":239,"type":22},6250,[25],"PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients.\n\nUtilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices.\n\nThe platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes.\n\nA domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. A domain may also be a non-interventional study that addresses observational research questions by collecting specific data or outcomes that are not collected as part of other domains. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies and mechanistic pathways within the same patient.\n\nOnce feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain. These adaptive analyses will compute the posterior probabilities of superiority, futility, inferiority, or equivalence for pre-specified comparisons within domains. Each of these potential conclusions will be pre-defined prior to commencing the intervention trial. Decisions about trial results (e.g., concluding superiority or equivalence) will be based on pre-specified threshold values for posterior probability. The primary outcome of interest, the definitions for superiority, futility, etc. (i.e., the magnitude of treatment effect) and the threshold values of posterior probability required to reach conclusions for superiority, futility etc., will vary from intervention to intervention depending on the phase of investigation and the nature of the intervention being evaluated. All of these parameters will be pre-specified as part of the statistical design for each intervention trial.\n\nIn general, domains will be designed to evaluate treatment effect within four discrete clinical states: non-intubated patients, intubated patients with low respiratory system elastance (\\\u003C2.5 cm H2O\u002F(mL\u002Fkg)), intubated patients with high respiratory system elastance (≥2.5 cm H2O\u002F(mL\u002Fkg)), and patients requiring extracorporeal life support. Where appropriate, the model will specify dynamic borrowing between states to maximize statistical information available for trial conclusions. In this perpetual trial design, different interventions may be added or dropped over time.\n\nWhere possible, the platform will be embedded within existing data collection repositories to enable greater efficiency in outcome ascertainment. Standardized systems for acquiring both physiological and biological measurements are embedded in the platform, to be acquired at sites with appropriate training, expertise, and facilities to collect those measurements.",[28,243,244],"Extracorporeal Membrane Oxygenation Complication","Mechanical Ventilation Pressure High","2026-05-01",{"date":247,"type":33},"2026-05-07",{"date":249,"type":33},"2023-04-30",{"date":251,"type":22},"2027-03-31",{"name":253,"class":40},"University Health Network, Toronto",89,{"id":256,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":26,"conditions":259,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":266,"locationsCount":41},"100410564",{"count":21,"type":22},[25],[28],"2026-04-17",{"date":262,"type":33},"2026-04-22",{"date":35,"type":33},{"date":265,"type":22},"2026-06-01",{"name":39,"class":40},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":41},"100633570","high-flow-nasal-cannula-after-major-abdominal-surgery-to-prevent-postoperative-pulmonary-complications-100633570","NCT07528404","High-Flow Nasal Cannula After Major Abdominal Surgery to Prevent Postoperative Pulmonary Complications","High-Flow Nasal Cannula for Prevention of Early Postoperative Pulmonary Complications After Major Abdominal Surgery: A Prospective Single-Center Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* Undergoing major abdominal surgery under general anesthesia.\n* Major abdominal surgery is defined as one of the following:\n\n  1. Upper gastrointestinal surgery: total gastrectomy, distal gastrectomy, proximal gastrectomy, or esophagogastric junction surgery.\n  2. Lower gastrointestinal surgery: right or left hemicolectomy, low anterior resection, anterior resection, total colectomy, abdominoperineal resection, or segmental small bowel resection with anastomosis.\n  3. Hepatobiliary and pancreatic surgery: hepatic resection (≥1 segment), right or left hepatectomy, central hepatectomy, distal pancreatectomy, pancreaticoduodenectomy (Whipple procedure), or bile duct resection with reconstruction.\n  4. Other moderate-to-major intra-abdominal procedures involving major organ resection or reconstruction, as determined by the investigator (e.g., complex cholecystectomy with extensive adhesiolysis, intra-abdominal tumor resection).\n* Actual anesthetic duration ≥ 3 hours, confirmed at the end of surgery.\n* Able to undergo immediate extubation at the end of surgery and be transferred to the post-anesthesia care unit or intensive care unit with spontaneous breathing.\n* Provided written informed consent before surgery. Final enrollment will occur only if the actual surgical procedure and anesthetic duration meet all eligibility criteria after surgery.\n\nExclusion Criteria:\n\n* Requirement for postoperative invasive mechanical ventilation. Failed extubation immediately after surgery.\n* Severe intraoperative instability preventing routine postoperative recovery (e.g., major hemodynamic instability, massive bleeding, or cardiopulmonary resuscitation).\n* Requirement for continuous oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation before surgery.\n* Thoracic surgery within 4 weeks before the index surgery. Inability to receive HFNC because of upper airway or nasal anatomical limitations.\n* Planned reoperation at the completion of the index surgery.\n* Inability to complete study participation or follow-up because of impaired decision-making capacity or practical inability to complete follow-up.\n* Any condition that, in the investigator's judgment, makes study participation inappropriate.","19 Years",{"count":276,"type":22},580,[25],"Major abdominal surgery is associated with a substantial risk of early postoperative pulmonary complications, including atelectasis, hypoxemia, pneumonia, and increased need for respiratory support. High-flow nasal cannula (HFNC) provides warmed and humidified oxygen at high flow rates and may improve oxygenation, reduce respiratory workload, and support lung volume during the immediate postoperative period. However, whether routine prophylactic HFNC after major abdominal surgery reduces clinically significant postoperative pulmonary complications remains uncertain.\n\nThis prospective, single-center, randomized controlled trial will evaluate whether prophylactic HFNC applied for 24 hours immediately after extubation reduces postoperative pulmonary complications compared with standard postoperative respiratory care in adult patients undergoing major abdominal surgery under general anesthesia with an actual anesthetic duration of 3 hours or longer.",[156,280,281,28],"Atelectasis","Pneumonia",[283,284,285,286,287,288,289],"High-flow nasal cannula","HFNC","PPC","Major abdominal surgery","Postoperative respiratory support","Postoperative pulmonary complications","Randomized controlled trial","2026-04-07",{"date":292,"type":33},"2026-04-14",{"date":169,"type":22},{"date":295,"type":22},"2027-12-31",{"name":297,"class":40},"Uijeongbu St. Mary Hospital",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":320,"leadSponsor":321,"locationsCount":4},"100630217","vela-generation-ii-usability-and-performance-of-a-non-invasive-ventilation-mask-100630217","NCT07484802","Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.","Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask. A Prospective Self-Controlled Study.","Inclusion Criteria:\n\n* Adults that are stable on prescribed NIV\n* Able to receive NIV therapy on a sub-nasal mask\n* Are 21 years old or older\n\nExclusion Criteria:\n\n* Contraindicated for NIV\n* NIV is likely to fail and\u002For intubation be required, at the doctor's discretion\n* CPAP or bilevel pressure of ≥ 30 cmH2O required\n* Do not fit the investigation mask or the standard mask\n* Pregnancy (tested under standard care)\n* Unable to tolerate NIV for the duration of the investigation\n* Unable to understand the consent process","21 Years",{"count":183,"type":22},[25],"Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with different ventilators, in people receiving NIV therapy for respiratory distress or respiratory insufficiency.\n\nThe main question(s) it aims to answer are:\n\n* Does the new mask reduce breathing rate compared with a standard NIV mask?\n* Does the ventilator perform as expected when used with the new mask, including pressure delivery and leak?\n* Do clinicians and participants find the new mask fits and functions well?\n\nThree iterations of the new mask (vented, non-vented, dual limb) will be compared to standard of care to see if the mask reduces the need to breathe and performs consistently across ventilators compared with usual NIV masks.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ What Participants Will Do Participants will wear two different NIV masks, each for one hour, during a single study session lasting approximately 2.5 hours.\n\nParticipants will be asked to:\n\n* Wear a small, stick on carbon dioxide (CO₂) sensor on the skin.\n* Use their usual NIV mask for one hour while ventilator data are collected.\n* Switch to the investigational mask for one hour while ventilator data are collected.\n* Choose whether to return to their original mask or remain on the investigational mask after the study period.\n* Caregiver opinion on the mask will be collected.\n\nParticipants may also choose (optional):\n\n* To have three small blood samples taken (These samples are optional, and participants can still take part in the study if they decline them.)\n\n  * One when they agree to take part in the study\n  * One when the investigational mask is fitted\n  * One after wearing the investigational mask for one hour\n* To provide feedback on how the two masks felt and performed.\n\nDuring the study, researchers will collect data from the ventilator, including:\n\n* Breathing rate and depth\n* NIV pressure settings\n* Amount of air leak Research staff will also complete a short form assessing how well the mask fit and functioned. Participants will remain in the study until the investigational mask is removed.",[28,310],"Respiratory Failure",[312,313,314,315],"Airway washout","Fisher and Paykel healthcare","optiNIV","vela gen 2","2026-03-18",{"date":318,"type":33},"2026-03-20",{"date":169,"type":22},{"date":295,"type":22},{"name":322,"class":115},"Fisher and Paykel Healthcare",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":340,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100555352","non-inferiority-of-continuing-oral-intake-versus-fasting-in-patients-with-acute-respiratory-failure-100555352","NCT06510972","Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure","Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial","JEUN-TUBE","Inclusion Criteria:\n\n* Male or female ≥ 18 years old\n* Participant affiliated to a social security scheme\n* Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin\n* Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours.\n* Criteria for acute hypoxaemic respiratory failure defined as.\n\n  * Respiratory rate \\> 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission.\n  * PaO2\u002FFiO2 \\\u003C 200 mmHg or equivalent SpO2 (oxygen saturation)\u002FFiO2 (fraction of inspired oxygen) i.e. \\\u003C 235 (measured under at least 10 L\u002Fmin high concentration mask)\n\nExclusion Criteria:\n\n* Patient with criteria for immediate intubation:\n\n  * Persistent or worsening respiratory failure (respiratory rate \\> 40\u002Fmin, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) \\\u003C 7.25, copious tracheal secretions, hypoxia with SpO2 \\\u003C 90% despite FiO2 \\> 80% for more than 5 minutes without technical dysfunction).\n  * Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion).\n  * Neurological failure (Glasgow score \\\u003C 8).\n  * Cardiac or respiratory arrest\n* Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome).\n* Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc.\n* Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy\n* Patient already on invasive mechanical ventilation on admission\n* Limitation of therapies including a decision not to intubate\n* Incapacitated adult (guardianship or curators)\n* Pregnant, parturient or breast-feeding women\n* Tracheostomised patient\n* Patient already included for the first time in this study",{"count":332,"type":22},754,[25],"Fasting in intensive care is mainly studied in mechanically ventilated patients or those in the weaning phase. Recent research challenge the common assumption of fasting and suggests that continuing enteral nutrition before extubation may be beneficial. Fasting is also practiced before procedures (e.g., tracheostomy, endoscopy) or surgeries, based on anesthetic guidelines. Yet, no data address fasting in non-intubated ICU patients with acute respiratory failure, despite frequent caloric deficits and inadequate nutritional intake.\n\nAspiration risk often justifies fasting, but studies indicate that swallowing reflexes remain intact in patients receiving high-flow nasal oxygen or non-invasive ventilation. Moreover, although intubation carries a 2-5.9% aspiration risk, rapid sequence induction mitigates this, questioning the necessity of preventive fasting. Despite its prevalence, this practice lacks scientific validation and guideline support.\n\nPatient discomfort is also significant. Hunger and thirst are major sources of distress, and evidence from anesthesiology suggests that allowing fluid intake pre-anesthesia reduces discomfort. Extrapolating these findings to ICU patients could improve well-being.\n\nIn conclusion, fasting in ICU patients may contribute to discomfort, dehydration, and malnutrition, while its protective benefits remain uncertain. We hypothesize that maintaining oral intake does not increase the risk of intubation or aspiration-related complications.",[28,336,337,338,339],"Fasting","Dysphagia","Swallowing Disorder","Aspiration",[341,342,343,344,345,346],"acute respiratory failure","fasting","oral intake","aspiration","intubation","high-flow nasal oxygen","2026-02-13",{"date":349,"type":33},"2026-02-18",{"date":351,"type":33},"2025-02-05",{"date":353,"type":22},"2028-03",{"name":355,"class":40},"University Hospital, Tours",14,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":4},"100625423","compliance-guided-abdominal-wall-closure-strategy-in-large-ventral-hernia-repair-100625423","NCT07422441","Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair","Impact of a Compliance-Guided Intraoperative Abdominal Wall Closure Decision Strategy on Early Postoperative Respiratory Failure After Large Ventral Hernia Repair Following Preoperative Botulinum Toxin A","CLOSE-STAT","Inclusion Criteria:\n\n* Age 18 years or older\n* Elective repair of a large ventral abdominal wall hernia (including incisional hernia)\n* Preoperative botulinum toxin A preparation performed as part of the local prehabilitation pathway\n* Preoperative abdominal CT available\n* General anesthesia with mechanical ventilation and feasibility of standardized intraoperative respiratory mechanics measurements\n\nExclusion Criteria:\n\n* Severe preoperative respiratory failure judged to preclude standardized intraoperative respiratory mechanics assessment\n* Inability to obtain reliable static respiratory system compliance measurements at predefined timepoints\n* Hemodynamic instability preventing protocolized measurements (as judged by the anesthesiologist)",{"count":366,"type":22},50,[25],"People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.",[370,371,156,28],"Hernia, Ventral","Hernia Incisional",[373,374,375,376,377,378,379],"adbominal wall closure","static compliance","respiratory system compliance","intraoperative monitoring","intra-abdominal pressure","complex hernia repair","botulinum toxin a","2026-02-12",{"date":382,"type":33},"2026-02-20",{"date":382,"type":22},{"date":385,"type":22},"2026-11-01",{"name":387,"class":40},"Swissmed Hospital",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":394,"sex":17,"minAge":50,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":408,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":41},"100557114","percutaneous-cryoablation-of-intercostal-nerves-for-the-treatment-of-rib-fractures-100557114","NCT06533904","Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures","Inclusion Criteria:\n\n* \\> 18 years old\n* \\> 2 rib fractures\n* Verbal Pain score \\> 5\n* Incentive Spirometry \\\u003C 60% of predicted\n\nExclusion Criteria:\n\n* Isolated Fractures of Ribs 1-3 and\u002For 10-12\n* Posterior Rib Fracture \\\u003C 4 cm from costovertebral joint\n* Sternal, Clavicle, Scapula Fracture\n* Thoracic Spinal Fracture of any type\n* Open Abdominothoracic Surgery\n* Unstable Spine\n* Extensive Subcutaneous Emphysema\n* BMI \\> 35\n* Plan for Rib Plating\n* Chronic Opioid Use\n* Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy\n* Coagulopathy, Shock at time of ablation\n* Inability to participate in activities of daily living prior to injury\n* Home O2 use prior to trauma\n* Inhalation Injury\n* Rib Fractures due to cardiopulmonary resuscitation\n* Life Expectancy \\\u003C 6 months\n* \\> 48 hours from injury\n* Pregnant, Incarcerated",true,"80 Years",{"count":397,"type":22},30,[25],"The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are:\n\nDoes percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium?\n\nResearchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery.\n\nParticipants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.",[401,402,403,28,404,405,406,310,407],"Trauma","Rib Fractures","Chest Wall Disorder","Pain, Chest","Rib Trauma","Rib Fracture Multiple","Respiratory Distress Syndrome",[401,310,409,28,402,410,411,412,413],"Respiratory Distress","Chest Wall Trauma","Percutaneous Cryoablation","Multimodal Pain Therapy","Multimodal Pain Regimen","2026-02-05",{"date":416,"type":33},"2026-02-09",{"date":418,"type":22},"2026-09",{"date":420,"type":22},"2028-07",{"name":422,"class":40},"Loma Linda University",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":41},"100402770","partial-neuromuscular-blockade-in-acute-hypoxemic-respiratory-failure-100402770","NCT04524585","Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure","PNEUMA","Inclusion Criteria:\n\nPatients supported on invasive mechanical ventilation for moderate to severe AHRF (PaO2\u002FFiO2 \\\u003C 150 mm Hg or FiO2 ≥ 60% with an SpO2 ≤ 97% or receiving venovenous extracorporeal membrane oxygenation)\n\nExclusion Criteria:\n\n1. Contraindication to neuromuscular blockade (allergy, history of malignant hyperthermia)\n2. Contraindication to ulnar nerve stimulation (bilateral peripheral neuropathy, skin burns on both wrists)\n3. Previous history of a formally diagnosed neuromuscular disorder",{"count":431,"type":22},23,[25],"PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with moderate to severe acute hypoxemic respiratory failure (AHRF) supported with invasive mechanical ventilation.",[28,435,436],"Neuromuscular Blockade","Mechanical Ventilation","2025-12-30",{"date":439,"type":33},"2026-01-06",{"date":441,"type":33},"2020-10-01",{"date":443,"type":22},"2027-03-01",{"name":253,"class":40},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":41},"100509473","combined-respiratory-training-in-persons-with-als-100509473","NCT05913882","Combined Respiratory Training in Persons With ALS","Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS","Inclusion Criteria:\n\n1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.\n2. Disease duration from symptom onset of ≤ 2 years,\n3. Lung volume recruitment and expiratory muscle strength training naïve,\n4. Reduced peak cough flow (% predicted for age and gender).\n\nExclusion Criteria:\n\n1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.\n2. Use of prescription cough assist or non-invasive volume ventilation devices.\n3. Enrollment in another research investigation that might impact cough or respiratory function.\n4. Diagnosis of frontotemporal dementia or advanced cognitive impairment.\n5. Tracheostomy placement\u002FUse of invasive mechanical ventilation.\n6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).","90 Years",{"count":454,"type":22},34,[25],"The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:\n\n1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.\n2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.\n3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.",[458,28,337],"ALS",[460,461,462,463],"Breathing","Swallowing","Exercise","Bulbar","2025-12-16",{"date":466,"type":33},"2025-12-23",{"date":468,"type":33},"2023-08-22",{"date":470,"type":22},"2026-09-30",{"name":472,"class":40},"Nova Southeastern University",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100553276","noninvasive-ventilation-facemasks-favoring-carbon-dioxide-washout-100553276","NCT06483984","Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout","Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure","MASHUP","Inclusion Criteria:\n\nAcute respiratory failure with\n\n* PaCO2 ≥ 45 mmHg;\n* Arterial pH \\\u003C 7.35;\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Respiratory rate \\\u003C 12 bpm;\n* Immediate need for intubation;\n* Haemodynamic instability (Systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) and\u002For lactic acidosis (lactate \\>5 mmol\u002FL) and\u002For clinically diagnosed shock;\n* Metabolic Acidosis;\n* Recent head surgery or anatomy that prevent the application of facemasks;\n* Any contraindications to oesophageal balloon insertion and\u002For electrical impedance tomography (EIT) belt placement.\n* Any contraindications to facemask noninvasive ventilation.",{"count":21,"type":22},[25],"The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure",[28],"2025-09-29",{"date":487,"type":33},"2025-09-30",{"date":489,"type":33},"2024-11-15",{"date":491,"type":22},"2026-10-01",{"name":493,"class":40},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",2,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":494},"100607398","the-impact-of-low-versus-high-positive-end-expiratory-pressure-on-diaphragm-function-ventilation-efficiency-and-lung-mechanics-100607398","NCT07188038","The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics","The Impact of Low Versus High Positive End-Expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics During Pressure Support Ventilation: A Randomized Interventional Crossover Study","INFLATE-ICU","Inclusion Criteria:\n\n* Mechanical ventilation with pressure support or mechanical ventilation with possibility to transition to pressure support\n* Oxygen requirement ≤ 50%\n* Pressure support ≤ 12 cmH2O\n* PEEP ≤ 12 cmH2O\n* Age ≥ 18 years\n* Adequate intravascular volume status\n\nExclusion Criteria:\n\n* Circulatory instability\n* Brain death diagnosis\u002Fbrain death evaluation\n* Norepinephrine dose \\> 0.4 µg\u002Fkg\u002Fmin\n* Muscle relaxation administered within 2 hours\n* Pregnancy\n* Contraindication to esophageal catheterization (e.g., esophageal varices)\n* Conditions with increased risk of pneumothorax (such as severe COPD (Chronic Obstructive Pulmonary Disease) or extensive emphysema)\n* Untreated pneumothorax\n* Symptomatic airway obstruction\n\nDiscontinuation criteria during ongoing study intervention:\n\n* Heart rate \\> 120 beats\u002Fmin\n* Systolic blood pressure \\> 180 mmHg\n* Inspired oxygen fraction \\> 70%\n* Respiratory rate \\> 35\u002Fmin\n* RASS (Richmond Agitation Sedation Scale) ≥ 2\n* Doubling of norepinephrine dose or increase of norepinephrine dose to \\> 0.5 µg\u002Fkg\u002Fmin to maintain mean arterial pressure\n* Bradycardia \\\u003C 45 beats\u002Fmin",{"count":7,"type":22},[25],"The goal of this interventional study is to evaluate the effect of different positive end-expiratory pressures (PEEP) on lung and diaphragm function in patients mechanically ventilated with pressure support ventilation in the intensive care unit. The main questions aim to answer:\n\nDoes higher PEEP level affect diaphragm contractions and ventilatory efficiency? Does higher PEEP level limit inspiratory efforts? Does higher PEEP level affect lung compliance?\n\nThe participants will be subjected to three different PEEP levels during pressure support ventilation:\n\nLow PEEP (4 cmH2O), Medium PEEP (10 cmH2O), High PEEP (16 cmH2O).\n\nThe lung and diaphragm function will be evaluated using high-resolution esophageal manometry, electrical activity of the diaphragm, external diaphragm ultrasound and spirometric ventilator data.",[310,507,281,28],"ARDS (Acute Respiratory Distress Syndrome)",[509,510,511,512,513,514,515,516],"Positive end-expiratory pressure","PEEP","pressure support ventilation","assisted breathing","Inspiratory effort","Inspiratory drive","Ventilation efficiency","Diaphragm","2025-09-15",{"date":519,"type":33},"2025-09-23",{"date":521,"type":22},"2025-10-01",{"date":295,"type":22},{"name":524,"class":174},"Vastra Gotaland Region",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":533,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":41},"100535403","phase-4-early-sedation-with-dexmedetomidine-vs-placebo-in-older-ventilated-critically-ill-patients-100535403","NCT06251375","Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients","Sedation Practice in Intensive Care Evaluation (SPICE IV) Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients: A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial","SPICEIV","Inclusion Criteria:\n\n1. Age ≥ 65 years\n2. Intubated and receiving invasive mechanical ventilation in an intensive care unit\n3. The treating clinicians believe that the patient will remain intubated and ventilated until the day after tomorrow (i.e. unlikely to be extubated the following day)\n4. The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.\n\nExclusion Criteria:\n\n1. Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours, with an additional 6-hour grace period, a total of 18 hours, in an intensive care unit\n2. Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury\n3. Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness\n4. Admission as a consequence of a suspected or proven drug overdose or burns\n5. Administration of or need for ongoing neuromuscular blockade\n6. A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization\n7. Heart rate less than 55 beats per minute or a high grade atrio-ventricular block in the absence of a functioning pacemaker\n8. Known sensitivity to dexmedetomidine\n9. Acute fulminant hepatic failure with EITHER\n\n   1. hepatic encephalopathy OR\n   2. bilirubin (\\>300 µmol\u002Fl) and INR (\\>3.5), or both, without prior hepatic dysfunction.\n10. Receiving full time residential nursing care\n11. Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment\n12. Underlying disease that makes survival to 90 days unlikely\n13. Previously enrolled in the SPICE IV study","65 Years",{"count":535,"type":22},300,[537],"PHASE4","Sedation remains a ubiquitous and crucial component of intensive care treatments in critically ill mechanically ventilated patients. Sedation relieves anxiety, reduces distress, and promotes tolerance of endotracheal intubation and associated life-sustaining interventions such as mechanical ventilation, cardiovascular assistance, and renal support. Thus, choosing the optimal sedative agent is vital to patient comfort, safety, and survival. Despite more than 20 years of intensive care sedation research, there is still no consensus on what constitutes best sedation practice. The Society of Critical Care Medicine, the premier critical care organisation in North America, published the 2018 Clinical Practice Guidelines on the management of Pain, Agitation\u002FSedation, Delirium, Immobility and Sleep (PADIS) disruption (chaired by our primary applicant W.A.) and issued weak recommendations to provide analgesia before sedation, to target light sedation whenever clinically feasible, and to use either dexmedetomidine or propofol over midazolam for the sedation of mechanically ventilated critically ill patients. Similarly, the American Thoracic Society produced a set of Clinical Practice Guidelines to promote liberation and weaning from mechanical ventilation in critically ill patients, with weak recommendations for the use of non-benzodiazepines as primary sedatives and to target light sedation when clinically possible. A weak recommendation was issued in an Intensive Care Medicine Rapid Practice Guideline published in 2022 to use dexmedetomidine over propofol for sedation of critically ill adults, if the desired outcome is a reduction in delirium. These guidelines, however, do not consider age-dependent pharmacokinetics and pharmacodynamics, illness severity, timing of sedative administration, operative vs medical reason for admission, or the changing dynamics of sedation practice at different phases of critical illness. The lack of high-level evidence to inform sedation practice in the critically ill has led to approaches that are mainly opinion-based and lack the support of evidence from large multicentre, international randomised clinical trials.",[28],[436,541,542,543],"Sedation","Randomized Control Trial","Acute Respiratory Failure","2025-09-03",{"date":546,"type":33},"2025-09-10",{"date":548,"type":22},"2025-09-07",{"date":550,"type":22},"2028-01-31",{"name":552,"class":40},"St. Joseph's Healthcare Hamilton",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":394,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":579},"100523947","multicenter-homevent-home-values-and-experiences-navigation-track-100523947","NCT06102330","Multicenter HomeVENT: Home Values and Experiences Navigation Track","HomeVENT","Inclusion Criteria:\n\n1. English- or Spanish-speaking\n2. Males and females; Age 18 and over.\n3. Parent of a child facing a decision about home ventilation within 30 days. A \"parent\" will be defined as any self-identified primary caregiver (parents, grandparents, etc).\n\n   or Physician of a child whose parents are enrolled in the study; physician must be engaged in the home ventilation decision.\n4. Provision of signed and dated informed consent form (parent) or completion of oral consent (physician)\n5. Stated willingness to comply with all study procedures and availability for the duration of the study\n6. Access to necessary resources if choose to participate via internet or telephone\n\nExclusion Criteria:\n\n1. Excluding children as they cannot be legal decision-makers\n2. Non-English or Non-Spanish speaking parents, as the intervention website\u002F videos are only available in those two languages.",{"count":561,"type":22},600,[25],"This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a child. The investigators hypothesize that the intervention will increase family preparedness for decision-making and will improve clinician-family shared-decision making. Half of families will be assigned to \"usual care\" arm and half to the \"intervention\" arm. Intervention families will view the study website with study staff and will answer questions related to website content. All families will be interviewed and surveyed at 1, 6 and 12 months after enrollment. Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed and surveyed at 1 month.",[565,28,566],"Pediatric ALL","Communication",[568,569],"chronic ventilation","decision-making","2025-07-30",{"date":572,"type":33},"2025-08-03",{"date":574,"type":33},"2024-02-06",{"date":576,"type":22},"2030-12",{"name":578,"class":40},"Johns Hopkins University",4,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":594,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":41},"100579103","effectiveness-of-platform-based-lateralization-therapy-in-reducing-interface-pressure-between-the-patient-and-the-support-surface-100579103","NCT06819943","Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface","PREVENT-ICU","Inclusion Criteria\n\n* Adult and elderly patients, aged 18 years or older;\n* Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning.\n\nExclusion Criteria\n\n* Requirement of norepinephrine \\> 0.3 mcg\u002Fkg\u002Fmin or mean arterial pressure \\\u003C 60 mmHg, despite the use of vasopressor agents;\n* Cardiac arrhythmias or bleeding leading to hemodynamic instability;\n* Neurological diseases or symptoms;\n* Spinal cord injury, such as paraplegia;\n* Cardiac pacemaker dependence;\n* Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome;\n* Air leakage from chest drains, presence of pneumothorax or undrained subcutaneous emphysema;\n* Presence of pre-existing pressure injuries in bony prominences (sacral, occipital, scapular, or calcaneal) at admission;\n* Medical refusal to include the patient in the study.",{"count":7,"type":22},[25],"Pressure injury (PI) is characterized as damage to the skin and\u002For underlying tissues resulting from sustained pressure or a combination of pressure and shear forces between the patient and the support surface. Prolonged pressure is a well-established risk factor in the development of PIs. Frequent repositioning and routine patient care have been recognized for decades as integral components of PI prevention and treatment protocols.\n\nThe duration of interface pressure is as critical as its magnitude. When interface pressure exceeds the mean capillary blood pressure, blood flow can be compromised, leading to ischemia in affected areas, which may progress to necrosis if sustained over time. Furthermore, it is widely accepted in the literature that tissue becomes at risk when interface pressure exceeds 30 to 32 mmHg.\n\nIn this context, continuous lateral rotation therapy (CLRT) offers a potential alternative for managing critically ill patients. CLRT involves continuous mechanical rotation of the patient in the lateral plane. However, its effects on skin integrity remain poorly understood. Despite the rationale behind and widespread recommendation of repositioning, the lack of robust evaluations on how repositioning impacts interface pressure creates uncertainty, underscoring the need for high-quality trials to assess different strategies for implementation.\n\nAlthough lateralization is a pragmatic strategy for preventing pressure injuries, its use in critically ill patients requires an integrated assessment of respiratory, hemodynamic, and gastroesophageal effects. Therefore, this study proposes an innovative approach by evaluating, for the first time, the effectiveness of automated postural change with simultaneous monitoring of tissue integrity, pulmonary function, cardiovascular stability, and gastroesophageal protection. The aim is to optimize pressure injury prevention, improve pulmonary mechanics, ensure hemodynamic stability, and preserve gastroesophageal safety in critically ill patients.",[28,591,592,593],"Pressure Injury","Intensive Care Medicine","ARDS",[595,596],"Continuous Lateral Rotation Therapy","Rotation Therapy","2025-06-17",{"date":599,"type":33},"2025-06-22",{"date":601,"type":33},"2024-06-01",{"date":603,"type":22},"2027-10",{"name":605,"class":40},"University of Sao Paulo General Hospital",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":41},"100580981","home-versus-hospital-based-niv-care-in-mnd-100580981","NCT06844370","Home Versus Hospital Based NIV Care in MND","Home Initiation and Monitoring of Non-invasive Ventilation (NIV) Versus Hospital-based Care in People with Motor Neurone Disease (MND) : a Randomised Control Trial (RCT) and Qualitative Study","HoHoNIV","Inclusion Criteria:\n\n* Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND.\n* Indications to NIV: daytime pCO2 \\>6.0 kPa or\u002Fand symptoms of ventilatory failure (e.g. orthopnoea, paroxysmal nocturnal dyspnoea, morning drowsiness) in the presence of significant diaphragmatic weakness confirmed by respiratory muscle tests\n\nExclusion Criteria:\n\n* Cognitive impairment precluding understanding of the study protocol and valid consent\n* Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive pulmonary disease (COPD), morbid obesity) causing or contributing to respiratory failure\n* Immediate need to start NIV (\\\u003C24hrs) and\u002For acute illness requiring inpatient treatment e.g. intravenous antibiotics for pneumonia (in addition to the need for NIV)\n* Lack of a sufficient social\u002Fprofessional network to support NIV application at home\n* Not wishing to accept home NIV",{"count":183,"type":22},[25],"Non-invasive ventilation (NIV) is commonly offered to people with Motor Neurone Disease (MND) who have breathing difficulties. It improves their quality of life and can prolong life by 6 months or more. It is initially used at night and typically set up during a hospital admission. By the time that they develop respiratory failure and need to start NIV, however, most patients require wheelchairs or have other significant health problems. Repeated travel to hospitals is increasingly difficult with increasing disability. It is possible to start and monitor NIV treatment at home. This may be more convenient for selected patients, though starting NIV is quite complex; it is not known if home treatment is as safe and effective as hospital-based treatment.\n\nTo establish this, 60 patients with MND who have indications for NIV will be recruited. They will be randomly allocated to a home-based treatment (home NIV set up plus home visits supported by telemonitoring) or hospital-based care (inpatient NIV set up plus outpatient NIV monitoring) and followed up at 1, 4 and 7 months. Alongside measures of treatment effectiveness, assessment of patient and carer preferences, quality of life, and cost-effectiveness will be undertaken.\n\nIn the additional qualitative part on this study, interviews with patients who took part in the main study and their carers will be conducted to understand in more depth their perspective on what makes for a good or bad experience with NIV, how the environment (home vs hospital) influences their NIV experience and what personal factors determine NIV use. Findings from the interviews will inform the design of a truly patient-centred NIV service.",[618,28],"Motor Neurone Disease",[620],"non invasive ventilation","2025-02-19",{"date":623,"type":33},"2025-02-25",{"date":625,"type":33},"2024-03-06",{"date":418,"type":22},{"name":628,"class":174},"Papworth Hospital NHS Foundation Trust",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":394,"sex":17,"minAge":50,"maxAge":637,"enrollmentInfo":638,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":640,"conditions":641,"keywords":645,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":494},"100508869","diaphragm-dysfunction-and-ultrasound-perioperatively-100508869","NCT05906030","Diaphragm Dysfunction and Ultrasound Perioperatively","Diaphragm Dysfunction and Respiratory Complications in the Perioperative Setting- Can Diaphragm Ultrasound Aid Prediction?","DiaphPeriop","Inclusion Criteria:\n\nAdults undergoing elective (study 1) or acute (study 2) abdominal, pelvic or vascular surgery\n\nExclusion Criteria:\n\n* \\\u003C18 years\n* Underlying chronic respiratory disease\n* Patients not able to give informed consent","100 Years",{"count":639,"type":22},160,"This study aims at determining whether diaphragm ultrasound examining diaphragm thickening fraction, excursion and density before and after surgery can predict respiratory complications in the postoperative period.\n\nPatients scheduled for major elective abdominal, pelvic or vascular surgery will be included in the study and diaphragm ultrasound is performed before surgery and after surgery in the postoperative ward. Physiological parameters, laboratory parameters, data on surgery and anesthesia and comorbidities will be registered. Complications such as pneumonia, desaturation, need for intubation and other respiratory events up to 30 days will be registered and later correlated with the diaphragm measurements.",[28,281,642,643,644],"Desaturation of Blood","Tachypnea","Atelectasis, Postoperative",[646,647,648,281,649],"Diaphragm dysfunction","Postoperative complication","Respiratory complication","Respiratory insufficiency","2025-01-27",{"date":652,"type":33},"2025-01-29",{"date":654,"type":33},"2024-09-01",{"date":656,"type":22},"2027-09-01",{"name":658,"class":40},"Karolinska University Hospital",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":395,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":41},"100576459","phase-2-the-evaluation-of-the-effectiveness-and-safety-of-nalbuphine-hydrochloride-injection-for-analgesia-in-icu-patients-a-multicenter-randomized-single-blinded-parallel-two-step-trial-100576459","NCT06785571","The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial","Inclusion Criteria:\n\n1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h\n2. patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form\n\nExclusion Criteria:\n\n1. Allergy or unsuitability to any composition of study drugs or propofol\n2. Living expectancy of less than 48 hours\n3. Neurological disorder and any other condition interfering with sedation assessment\n4. Gastrointestinal obstruction\n5. Asthmatic\n6. Abdominal compartment syndrome\n7. Serious hepatic dysfunction (CTP 10-15)\n8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \\\u003C 29 ml\u002Fmin\u002F1.73m2\n9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug\u002Fkg\u002Fmin to maintain proper blood pressure)\n10. Need deep sedation or paralytics\n11. Anticipation to receive operations (including tracheotomy)\n12. Abuse of controlled substances or alcohol\n13. Pregnancy, lactation, or an intention of gestation in 6 months\n14. Inclusion in another interventional trial in the past 30 days\n15. Other conditions deemed unsuitable to be included",{"count":666,"type":22},204,[54,668],"PHASE3","The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.",[28],"2025-01-19",{"date":673,"type":33},"2025-01-21",{"date":675,"type":33},"2023-08-30",{"date":677,"type":22},"2025-10-31",{"name":679,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":394,"sex":17,"minAge":687,"maxAge":688,"enrollmentInfo":689,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":691,"conditions":692,"keywords":698,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":41},"100574234","respiratory-functions-thoracoabdominal-movements-and-exercise-capacity-in-neuromuscular-diseases-100574234","NCT06756633","Respiratory Functions, Thoracoabdominal Movements and Exercise Capacity in Neuromuscular Diseases","Evaluation of Respiratory Functions, Thoracoabdominal Movements, and Exercise Capacity in Neuromuscular Diseases","1. Duchenne Muscular Dystrophy (DMD)\n\n   -Inclusion Criteria: Clinically diagnosed with Duchenne Muscular Dystrophy. Age above 5 years. Able to breathe independently. Willing to participate in the study.\n\n   -Exclusion Criteria: Presence of cognitive problems that affect the assessment results. History of pulmonary surgery. Advanced heart failure.\n2. Spinal Muscular Atrophy (SMA)\n\n   -Inclusion Criteria: Clinically diagnosed with Spinal Muscular Atrophy. Age above 5 years. Able to breathe independently. Willing to participate in the study.\n\n   -Exclusion Criteria: Presence of cognitive problems that affect the assessment results. History of pulmonary surgery. Advanced heart failure.\n3. Healthy Controls\n\n   * Inclusion Criteria:\n\nNo diagnosis of neuromuscular diseases. Age above 5 years. Able to breathe independently. Willing to participate in the study.\n\n-Exclusion Criteria: Presence of cognitive problems that affect the assessment results. History of pulmonary surgery. Advanced heart failure.","5 Years","15 Years",{"count":690,"type":22},42,"The clinical trial titled \"Investigation of Respiratory Functions, Thoracoabdominal Movements, and Exercise Capacity in Neuromuscular Diseases\" aims to evaluate the respiratory functions, thoracoabdominal movements, and exercise capacity in children with Duchenne Muscular Dystrophy (DMD) and Spinal Muscular Atrophy (SMA) compared to healthy controls. The study will use spirometry, structured light plethysmography (SLP), the six-minute walk test, and the six-minute pegboard ring test to assess these functions. This trial will be conducted at the Lokman Hekim University Muscle and Nerve Diseases Application and Research Center from May 2024 to Dec 2025.",[693,694,28,695,696,697],"Neuromuscular Diseases in Children","Respiratory Function Impaired","Duchenne Muscular Dystrophy","Spinal Muscular Atrophy","Plethysmography",[699,700,701,702],"Duchenne muscular dystrophy","Spinal muscular atrophy","respiratory function tests","plethysmography","2024-12-25",{"date":705,"type":33},"2025-01-03",{"date":707,"type":33},"2024-04-01",{"date":709,"type":22},"2025-12-28",{"name":711,"class":174},"Lokman Hekim University"]