[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-insufficiency-requiring-mechanical-ventilation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-insufficiency-requiring-mechanical-ventilation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,85,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100598472","phase-2-a-clinical-trial-of-early-ventilation-in-amyotrophic-lateral-sclerosis-event-als-100598472",false,"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","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34,35,36],"Amyotrophic Lateral Sclerosis (ALS)","Chronic Respiratory Failure","Neuromuscular Disease Patients","Neuromuscular Disease","Respiratory Insufficiency","Respiratory Insufficiency Requiring Mechanical Ventilation","Positive Pressure Ventilation","Non-invasive Ventilation","Non-invasive Ventilation Support","Non-invasive Ventilatory Support",[38,39,40,41],"chronic respiratory failure","chronic neuromuscular respiratory failure","non-invasive ventilation","amyotrophic lateral sclerosis","RECRUITING","2026-06-25",{"date":45,"type":46},"2026-06-26","ACTUAL",{"date":48,"type":46},"2026-06-11",{"date":50,"type":21},"2029-05",{"name":52,"class":53},"University of Pennsylvania","OTHER",3,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":5},"100566486","registry-for-automated-mechanical-ventilation-in-adults-100566486","NCT06655805","Registry for Automated Mechanical VEntilation in Adults","RAVE","Inclusion Criteria:\n\nAge ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.\n\nExclusion Criteria:\n\nExpected to be weaned from HFNO, NIV within 2 hours. Expected to be weaned and extubated from IMV without subsequent need of HFNO or NIV support within 2 hours.\n\nExpected to be transferred to another non-participating ICU within 2 hours. Moribund subject: death expected within 2 hours.",{"count":63,"type":21},1000,"28 Days","OBSERVATIONAL","The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.",[32],[69,70,71,72,73,74],"Real world data","Acute respiratory failure","Respiratory support","Invasive Mechanical Ventilation (IMV)","Non Invasive Ventilation (NIV)","High Flow Nasal Oxygen (HFNO)","2026-01-15",{"date":77,"type":46},"2026-01-16",{"date":79,"type":46},"2024-09-23",{"date":81,"type":21},"2030-12-31",{"name":83,"class":84},"Hamilton Medical AG","INDUSTRY",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":65,"phases":4,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100602202","comparison-of-diaphragm-ultrasound-and-rsbi-for-predicting-weaning-success-in-mechanically-ventilated-icu-patients-100602202","NCT07120438","Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients","Comparison Between Diaphragmatic Ultrasound and Rapid Shallow Breathing Index (RSBI) in Predicting Weaning Success in Patients on Mechanical Ventilation for More Than 48 Hours in the ICU of Dr. Sardjito Hospital, Yogyakarta","Inclusion Criteria:\n\n1. Patients who have been on mechanical ventilation for more than 48 hours\n2. Adult patients aged ≥18 years\n3. Patients who meet the criteria for hemodynamic stability for weaning\n4. Patients or their families have provided written informed consent\n5. Patients with FiO₂ \\\u003C 50%, PEEP level \\\u003C 5 cm H₂O, respiratory rate \\\u003C 30 breaths per minute, PaO₂\u002FFiO₂ \\> 200, and GCS \\> 13\n6. Patients who have successfully completed the Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)\n\nExclusion Criteria:\n\n1. Patients with neuromuscular disorders, anatomical abnormalities of the diaphragm, or diaphragmatic palsy\n2. Patients with a history of severe thoracic trauma affecting diaphragm function on one or both sides\n3. Pregnancy",{"count":93,"type":21},55,"2 Days","The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours.\n\nThe main question it aims to answer is:\n\nWhich is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \\[DE\\] and Diaphragm Thickening Fraction \\[DTF\\]) or RSBI, in patients ventilated \\>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta?\n\nParticipants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes.\n\nSecondary objectives include:\n\n1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.\n2. Evaluating the correlation between DE values and successful weaning.\n3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.\n4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.\n5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.",[97,98,32,99,100,101],"Ventilator Weaning","Mechanical Ventilation","Weaning From Mechanical Ventilation","Weaning From Mechanical Ventilation in Care Unit","Intensive Care Unit Patients",[103,104,105,106,107,108,109],"Diaphragmatic Ultrasound","Rapid Shallow Breathing Index","Diaphragm Thickening Fraction","Diaphragm Excursion","Weaning Prediction","ICU","Weaning Failure","NOT_YET_RECRUITING","2025-08-06",{"date":113,"type":46},"2025-08-13",{"date":115,"type":21},"2025-08",{"date":117,"type":21},"2026-03",{"name":119,"class":53},"Gadjah Mada University",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":54},"100565617","the-efficient-picu-fluid-care-evaluation-100565617","NCT06644508","The Efficient PICU Fluid Care Evaluation","LESSER-2","Inclusion Criteria:\n\n* Age \\\u003C 10 years and weight \\\u003C 35 kg\n* Receiving invasive mechanical ventilation (IMV) due to respiratory failure\n* Inclusion possible within 24 hours of start of IMV\n* Expected duration of IMV \\> 48 hours\n\nExclusion Criteria:\n\n* Preterm (\\\u003C37weeks gestational age)\n* Preexistent (clinical) diagnosis of kidney disease\n* Congenital cardiac defect with hemodynamic consequences or reduced cardiac function\n* (Ongoing) shock with need for fluid resuscitation and\u002For vasoactive drugs\n* Cardiovascular (including diuretics) drug use on admission (home medication)\n* Pre-existent (clinical) diagnosis of liver failure\n* Right of left heart failure\n* Pulmonary hypertension\n* ECMO treatment\n* Receiving total parenteral nutrition on admission which won't be stopped\n* Failure to include within 12 hours after start of IMV\n* Expected duration of IMV \\\u003C 48 hours\n* Parents or caretakers unable to understand\u002Fspeak Dutch language\n* Surgery \\\u003C 48 hours","10 Years",{"count":129,"type":21},90,[131],"NA","The goal of this clinical trial is to evaluate and prevent fluid overload in critically ill, mechanically ventilated children. The main questions it aims to answer are:\n\n1. What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?\n2. What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?\n\nResearchers will compare the effects of strict adherence to the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) guidelines regarding fluid balance (i.e. restricting fluid intake and preventing a positive fluid balance) to current local practice.\n\nFrom the start to the end of invasive mechanical ventilation participants will be treated according to local practice or with the strict aim to prevent a positive fluid balance. Aiming to prevent a positive fluid balance, if this is possible given the clinical context, is at descretion of the attending physician. Minimal caloric intake requirements must be met.\n\nParticipants are studied for ten days during invasive mechanical ventilation or until discharge from the intensive care",[32,134,135],"Fluid Overload","Fluid Balance",[31,137,138,135,139,134,140,141,142],"Mechanical ventilation","Fluids","Edema","Lenght of mechanical ventilation","Childeren","Maintenance fluids","2024-10-14",{"date":145,"type":46},"2024-10-16",{"date":147,"type":21},"2024-10",{"date":149,"type":21},"2025-05",{"name":151,"class":53},"Radboud University Medical Center"]