[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-hypoxemic-respiratory-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-hypoxemic-respiratory-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,74,100,126,151,172,198,227,249,275,298,331,358,387,411,440,465,491,517,541,565,592,618,645],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100627728","protocolized-weaning-of-high-flow-nasal-cannula-in-adult-patients-100627728",false,"NCT07452406","Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients","Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients: A Stepped-Wedge Cluster Randomized Trial (PRO-WEAN HFNC)","PRO-WEAN HFNC","Inclusion Criteria:\n\n* Adult patients ≥ 18 years\n* Receiving HFNC for ≥12 hours\n* Receiving HFNC to treat acute hypoxemic respiratory failure, defined as requirement of FIO2 ≥ 0.5 to maintain SpO2 at 90-97% and Evidence of increased work of breathing at initiation (e.g., tachypnea with respiratory rate \\> 20-25\u002Fmin, or accessory muscle use), including:\n\n  * Patients using HFNC to avoid intubation\n  * Post-extubated patients who develop acute hypoxemic respiratory failure, regardless of respiratory support device prior to HFNC use.\n* The bedside clinical team determines that HFNC weaning is clinically appropriate\n* Demonstrates clinical stability, defined as:\n\n  * Respiratory rate ≤ 25 breaths per minute without use of accessory respiratory muscles\n  * SpO₂ \\> 90% on HFNC\n  * HFNC FiO₂ ≤ 0.80\n\nExclusion Criteria:\n\n* • Planned procedures requiring intubation\n\n  * Hypercapnia (PaCO2 ≥ 45 mmHg)\n  * Receiving extracorporeal membrane oxygenation (ECMO)\n  * Receiving continuous aerosol therapy via HFNC (e.g., inhaled nitric oxide \\[iNO\\], epoprostenol, or continuous albuterol)\n  * Receiving chronic home use of HFNC, CPAP, or noninvasive ventilation therapy to treat chronic respiratory failure\n  * Receiving HFNC as preventative post-extubation therapy, defined as HFNC use immediately after extubation for less than 48 hr in the absence of clinical signs of respiratory failure.","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","INTERVENTIONAL",[24],"NA","High-flow nasal cannula (HFNC) is a type of oxygen therapy commonly used in adults with breathing problems. While HFNC can help patients avoid breathing tubes and improve oxygen levels, there is no standard method for deciding how and when to reduce and stop this therapy once a patient improves. In many hospitals, these decisions vary from clinician to clinician.\n\nThis study will compare usual care with a standardized step-by-step plan for reducing HFNC support. Eight hospitals will participate and will switch from usual care to the standardized plan at different time points during the study.\n\nThe main goal is to determine whether the standardized weaning plan increases the number of patients who can successfully stop HFNC within 5 days. The study will also evaluate how long patients remain on HFNC, whether they need additional breathing support, and how long they stay in the hospital.\n\nThe results may help develop clearer guidance for safely and efficiently stopping HFNC therapy.",[27,28],"Acute Hypoxemic Respiratory Failure","High-Flow Nasal Cannula Therapy",[30,31,32],"High-flow nasal cannula","Acute hypoxemic respiratory failure","Weaning","NOT_YET_RECRUITING","2026-06-07",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2028-06-28",{"name":43,"class":44},"Rush University Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100643705","predicting-high-flow-nasal-cannula-failure-in-acute-hypoxemic-respiratory-failure-using-metabolomics-and-clinical-data-100643705","NCT07607080","Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data","Metabolomics and Clinical Data to Predict High-Flow Nasal Cannula Failure and Optimize Respiratory Support in Acute Hypoxemic Respiratory Failure","META-RESPIRE","Inclusion Criteria:\n\n* Adult patients (≥18 years old).\n* Admission to the intensive care unit (ICU) with acute hypoxemic respiratory failure (AHRF).\n* Treatment with high-flow nasal cannula (HFNC) as the initial respiratory support strategy.\n* Inclusion within the first 24 hours after HFNC initiation.\n* Provision of informed consent by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Active do-not-resuscitate (DNR) orders or limitation of therapeutic effort.\n* Refusal or inability to provide informed consent.\n* Previous invasive mechanical ventilation before study inclusion.",{"count":55,"type":21},300,"OBSERVATIONAL","The goal of this observational study is to determine whether metabolomic profiles combined with clinical data can predict high-flow nasal cannula (HFNC) failure and help optimize respiratory support in adult patients with acute hypoxemic respiratory failure (AHRF). The main questions it aims to answer are:\n\nCan metabolomic biomarkers identify patients at higher risk of HFNC failure? Does combining metabolomic and clinical data improve the prediction of respiratory support escalation and clinical outcomes?\n\nParticipants will:\n\nReceive standard HFNC treatment according to clinical practice. Undergo collection of clinical, physiological, and laboratory data. Provide blood samples for metabolomic analysis during respiratory support.",[27],[60,61,62,63,64],"Acute Hypoxemic Respiratory Failure (AHRF)","High-Flow Nasal Cannula (HFNC)","Metabolomics","Respiratory Failure Prediction","Noninvasive Respiratory Support","RECRUITING","2026-06-04",{"date":68,"type":37},"2026-06-08",{"date":66,"type":37},{"date":71,"type":21},"2029-05",{"name":73,"class":44},"Hospital del Mar Research Institute (IMIM)",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100586920","targeting-pressure-muscle-index-to-avoid-ventilatory-over-assistance-during-pressure-support-ventilation-100586920","NCT06921655","Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation","Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure","TEMA","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Mechanically ventilated in the ICU\n3. Diagnosis of Acute Hypoxemic Respiratory Failure (AHRF)\n4. Normocapnia or non-severe hypercapnia\n5. Receiving Pressure Support Ventilation (PSV) for at least 24-72 hours\n6. Presence of an arterial line for blood gas sampling\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Known neurological or neuromuscular disorders affecting diaphragm function\n3. Chronic Obstructive Pulmonary Disease (COPD) or hypercapnic respiratory failure\n4. Psychomotor agitation or inadequate sedation",{"count":83,"type":21},36,[24],"The TEMA study (Targeting prEssure-Muscle-index to avoid ventilatory over-Assistance during pressure support ventilation) is a prospective, interventional crossover trial investigating the relationship between pressure support (PS) and tidal volume (Vt) in ICU patients with acute hypoxemic respiratory failure (AHRF) receiving pressure support ventilation (PSV). The study aims to assess whether the Pressure-Muscle Index (PMI)-a marker derived from the difference between plateau and peak inspiratory pressure-can help identify the optimal level of ventilatory assistance, preventing over-assistance and its associated complications such as diaphragm atrophy and patient self-inflicted lung injury (P-SILI). By exploring the sigmoidal relationship between PS and Vt, the study seeks to define a physiological threshold (PMI=0) that may serve as a personalized target for PSV titration.",[27,87],"Mechanical Ventilation Complication",[89,90,27],"Pressure Support","Tidal Volume","2026-06-03",{"date":93,"type":37},"2026-06-05",{"date":95,"type":37},"2025-10-08",{"date":97,"type":21},"2028-12-15",{"name":99,"class":44},"Centre for Medical Sciences",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100606410","association-between-eit-and-ct-during-peep-titration-in-patients-with-acute-respiratory-failure-100606410","NCT07175194","Association Between EIT and CT During PEEP Titration in Patients With Acute Respiratory Failure","Association Between the \"Best\" Positive End-Expiratory Pressure Identified With Electrical Impedance Tomography and the Potential for Hyperinflation and Collapse Assessed With Lung Computed Tomography in Mechanically Ventilated Patients With Acute Respiratory Failure","TAC-EIT-20-5","Inclusion Criteria:\n\n* Adults (≥18 years of age) admitted to our Unit with ARF treated with mechanical ventilation\n* The patient undergoes a lung CT and EIT to guide the setting of PEEP as part of our routine clinical practice\n\nExclusion Criteria:\n\n* The patient cannot undergo a lung CT and\u002For EIT as judged by the attending physician (for instance, transport to the radiology unit may be considered too risky if the patient is extremely severe, or using EIT may be contraindicated because of the presence of a pacemaker)\n* Pregnancy (as this condition alters the respiratory physiology)",{"count":109,"type":21},30,"This observational study will analyze data already collected by the investigators as part of their routine clinical practice from patients with acute respiratory failure (ARF) treated with mechanical ventilation. The study itself does not require any specific intervention.\n\nMechanical ventilation can save the lives of patients with ARF. However, if used improperly, it can exacerbate lung disease and worsen outcomes (Slutsky et al.).\n\nDespite decades of animal and clinical research, it remains unclear how to establish the positive end-expiratory pressure (PEEP) during mechanical ventilation to reduce the risk of lung damage. Several methods have been suggested, but none have consistently proven superior to the others (Sahetya et al.).\n\nAs part of their routine clinical practice, the investigators study the responses to different PEEP levels of patients with ARF undergoing mechanical ventilation by integrating information from various techniques, each examining different aspects of lung morphology and physiology. The methods the investigators use include lung computed tomography (CT) and electrical impedance tomography (EIT). Lung CT is the reference technique for measuring the morphological response to PEEP (Gattinoni et al.). It quantifies the volume of the hyperinflated and non-aerated lung, both of which are related to the risk of mechanical ventilation causing damage (Slutsky et al.). Lung EIT monitors the functional response to PEEP in terms of changes in regional compliance across different PEEP levels. Allegedly, an increase in compliance when PEEP is decreased reveals overdistention, the functional correlate of (worrisome) hyperinflation, at the higher PEEP. A decrease in compliance when PEEP is decreased signals new collapse, the functional correlate of (worrisome) loss of aeration (Franchineau et al.).\n\nIn the Unit where the investigators work, patients with ARF treated with mechanical ventilation are routinely studied as follows. First, a lung CT with a PEEP of 20 cmH2O and then of 5 cmH2O is obtained. Thereafter, a decremental PEEP test is performed with the EIT, where PEEP is decreased from 20 cmH2O down to 5 cmH2O in steps of 2 or 3 cmH2O. Finally, results are analyzed and compared offline.\n\nAt the lung CT, decreasing PEEP from 20 to 5 cmH2O is always associated with some decrease in the volume of the hyperinflated lung and some increase in the volume of the non-aerated lung. However, the magnitude of these two effects varies among individuals, and the net response may be defined as the difference between those two competing effects. If the decrease in the volume of the hyperinflated lung is greater than the increase in the volume of the non-aerated lung, the overall response (i.e., less hyperinflation) can be considered positive. PEEP should then be set closer to 5 than to 20 cmH2O. Diversely, if the decrease in the volume of the hyperinflated lung is smaller than the increase in the volume of the non-aerated lung, the overall response (i.e., more loss of aeration) can be considered negative. PEEP should then be set closer to 20 cmH2O (Protti et al.). Similarly, at the lung EIT, decreasing PEEP from 20 to 5 cmH2O is always associated with compliance improvement in some regions (i.e., less overdistension) and worsening in others (i.e., more collapse). Again, the magnitude of these two opposite effects varies among individuals. According to most experts on lung EIT, PEEP should be set at the level where both overdistension and collapse are minimized (the so-called \"best\" PEEP) (Jonkman et al.).\n\nLung CT requires transfer to the radiology unit, exposure of the patient to radiation, and complex analysis offline. By contrast, lung EIT is virtually risk-free, and analysis can be performed using an automatic algorithm. Nevertheless, lung EIT is less well validated than lung CT. For instance, the assumption that a decrease in compliance in response to a decrease in PEEP is due to new collapse has been questioned (Protti et al., Chiumello et al., Menga et al.). So far, lung CT remains the reference technique for studying individual responses to PEEP, while lung EIT requires further validation.\n\nThis study aims to verify whether the \"best\" PEEP identified using lung EIT is strongly associated with the net response assessed using lung CT, when PEEP is decreased from 20 to 5 cmH2O in patients with ARF treated with mechanical ventilation. If so, this would strengthen the rationale for using the lung EIT (which is safer and simpler than the lung CT) to set PEEP.",[27,112],"Ventilation, Mechanical",[114,115,116],"Positive End-Expiratory Pressure","Computed Tomography","Electrical Impedance Tomography","2026-05-17",{"date":119,"type":37},"2026-05-19",{"date":121,"type":37},"2025-11-01",{"date":123,"type":21},"2027-06",{"name":125,"class":44},"Istituto Clinico Humanitas",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100554594","optimizing-care-in-critically-ill-at-uchealth-by-liberalizing-the-target-o2-in-mechanically-ventilated-icu-patients-100554594","NCT06501118","Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients","Inclusion Criteria:\n\n* Admission to ICU and requiring invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Transferred patients from outside the UCHealth system\\*:\n* Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy\\*:\n* Pregnant women:\n* Prisoners\n* Patients receiving mechanical ventilation for less than twelve hours",{"count":133,"type":21},3600,[24],"A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.",[137,27,138,139,140,141],"Respiratory Failure","Acute Hypoxic Respiratory Failure","Hypoxemia","Hypoxia","Hypoxic Respiratory Failure","2026-05-04",{"date":144,"type":37},"2026-05-08",{"date":146,"type":37},"2024-09-01",{"date":148,"type":21},"2026-07-31",{"name":150,"class":44},"University of Colorado, Denver",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":45},"100587711","awake-prone-positioning-in-spontaneous-breathing-patients-with-acute-hypoxic-respiratory-failure-due-to-pneumonia-100587711","NCT06931938","Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia","Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study","PROSA","Inclusion Criteria:\n\n* The focus of this trial is to treat patients with respiratory failure. The inclusion criteria are selected accordingly. Patients meeting all of the criteria listed below will be included in the study:\n\n  * Patients in the intensive care unit\n  * High possibility of Pneumonia (community-acquired pneumonia or hospital-acquired pneumo-nia) either diagnosed by chest x-ray or computed tomography or clinically diagnosed at least with one of the following signs\n\n    * Appearance of purulent secretions or changes in characteristics (color, odor, quantity, consistency)\n    * Cough or dyspnea or tachypnea\n    * Evocative auscultation\n  * Presence of acute hypoxemic respiratory failure (PaO2\u002FFIO2 ≤ 300 mmHg or SpO2\u002FFiO2 ≤ 315)\n\nExclusion Criteria:\n\n* Patients are excluded from the study if any of the following criteria are met at screening or before ran-domization, a detailed list is shown in the study manual:\n\n  * Age below 18\n  * Pregnant woman\n  * Patient is unlikely\u002Funable to awake prone positioning, or to be compliant as indicated by the treating team\n  * Prolonged need (≥ 4 days) for HFNO, NIV or CPAP before study inclusion\n  * Urgent need for endotracheal intubation\n  * Invasive Mechanical Ventilation\n  * Shock\n\n    o Defined as need for vasopressor ≥ 0.4 mcg\u002Fkg\u002Fmin to maintain a mean blood pressure of ≥ 65 mmHg or systolic blood pressure ≥ 90 mmHg\n  * Participation in another clinical interventional trial in the last 3 months\n  * Previous Participation in the PROSA Trial\n  * Long-term oxygenation therapy (LTOT) or continuous positive airway pressure (CPAP) therapy before hospital admission\n  * Treatment",{"count":160,"type":21},342,[24],"Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesis that awake prone position in patients with AHRF is superior to standard supine\u002Fsemi-recumbent position in terms of reducing the rate of tracheal intubation and\u002For all-cause death within 28 days after randomization.",[27],"2026-04-28",{"date":142,"type":37},{"date":167,"type":37},"2025-04-11",{"date":169,"type":21},"2027-06-30",{"name":171,"class":44},"Universitätsklinikum Hamburg-Eppendorf",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":45},"100628345","bag-cpap-vs-standard-oxygen-therapy-in-acute-hypoxemic-respiratory-failure-100628345","NCT07460427","Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure","Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial","BAGCPAP-R","1. Inclusion criteria\n\n   All patients aged 18 years or older will be included in the study if they meet the following criteria:\n   * De novo acute respiratory distress, characterized by the presence of dyspnea at rest, the use of accessory muscles for breathing, or a respiratory rate of 25 cycles per minute or more.\n   * Hypoxemia, defined as a SpO2\u002FFiO2 ratio less than 315 or a PaO2\u002FFiO2 ratio less than 300 mmHg (if arterial blood gas is available) despite an oxygen therapy of 6 L\u002Fmin. FiO2 will be estimated by the rule of 3% (Coudroy formula)(18,22). SpO2 should be less than 98% when assessing the SpO2\u002FFiO2 ratio.\n2. Exclusion criteria\n\nPatients with one of the following criteria will be excluded from the study:\n\n* Absolute contraindications to CPAP: patient's refusal, uncontrollable vomiting, upper gastrointestinal bleeding, open or sucking chest wound, pneumothorax not drained, craniofacial trauma, severe burns to the face, severe upper airway obstruction, traumatic tetraplegia at the initial stage, tracheostomy.\n* Moderate to massive pleural effusion not drained\n* Cardiac arrest, severe ventricular arrhythmias, and shock defined as the need for vasopressor support (adrenaline, noradrenaline, or dopamine)\n* Altered level of consciousness (GCS below 12), repetitive convulsions, or status epilepticus\n* Do not intubate or resuscitate order before the inclusion in the study\n* Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure",{"count":181,"type":21},250,[24],"Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF.\n\nThis is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.",[27],[186,187,137,188],"CPAP","Randomized controlled trial","Low resource setting","2026-03-16",{"date":191,"type":37},"2026-03-19",{"date":193,"type":21},"2026-04-20",{"date":195,"type":21},"2027-03-20",{"name":197,"class":44},"Prof RWABIHAMA Jean Paul",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100628611","spontaneous-vs-controlled-mechanical-ventilation-in-acute-hypoxemic-respiratory-failure-100628611","NCT07463885","Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure","Spontaneous Versus Controlled Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure: A Feasibility Study and Pilot Trial","SVALBARD","Inclusion Criteria:\n\nWe will include patients who fulfil all the following criteria:\n\n* Acutely admitted to the ICU\n* AND age ≥ 18 years\n* AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours\n* AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation.\n* AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation.\n\nExclusion Criteria:\n\n* Previously randomised into the SVALBARD trial.\n* Informed consent following inclusion expected to be unobtainable\n* Patient under coercive measures\n* Withdrawal from active therapy or brain death deemed imminent.\n* Chronic hypercapnic respiratory failure defined as PaCO2 \\> 8 kPa (60 mm Hg) in the outpatient setting.\n* Listed for lung transplant.\n* Acute heart failure \u002F acute myocardial infarction \u002F cardiac arrest during or causing index ICU admission.\n* Use of home oxygen.\n* Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP\u002FBIPAP) used solely for sleep apnoea disorder.\n* Currently receiving ECMO therapy.\n* Burns \\>70 % total body surface.\n* Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH).\n* Intracranial hypertension.\n* Patients with planned repeat surgical interventions during current stay in ICU.",{"count":207,"type":21},80,[24],"Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain.\n\nThe SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure.\n\nThe primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.",[211,27],"Acute Respiratory Distress Syndrome (ARDS)",[213,31,214,215,216,217,218],"Acute respiratory distress syndrome","Mechanical ventilation","assisted ventilation","controlled ventilation","feasibility trial","randomised clinical trial","2026-03-11",{"date":221,"type":37},"2026-03-13",{"date":39,"type":21},{"date":224,"type":21},"2028-03-30",{"name":226,"class":44},"Oslo University Hospital",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":45},"100618650","phase-2-interleukin-6-guided-treatment-with-dexamethasone-or-tocilizumab-in-patients-hospitalized-with-acute-respiratory-symptoms---a-feasibility-study-100618650","NCT07334379","Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study","IDENTIFY","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Presence of new onset of respiratory symptoms in the previous 14 days upon presentation at the emergency department. Respiratory symptoms are characterized by at least one of the following: cough, dyspnea, or requirement of oxygen supplementation\n3. Requirement of inpatient hospital management\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Patients with known contraindications to dexamethasone or tocilizumab, or any of their components\n3. Allergic reaction to tocilizumab or other monoclonal antibodies\n4. Patients who are using azathioprine or cyclophosphamide\n5. Active tuberculosis infection\n6. Patients who have active hepatic disease or hepatic impairment\n7. ALT or AST \\>3x upper limit of normal\n8. Neutrophil count \\\u003C1000\u002Fmcl\n9. Platelet count \\\u003C50,000\u002Fmm3\n10. Hemoglobin (Hb) below 8.5 g\u002FdL,\n11. White blood cell count (WBC) below 3000\u002Fmm3\n12. Absolute Neutrophil Count (ANC) below 2.0 x 109\u002FL\n13. absolute lymphocyte count below 500\u002Fmm3\n14. total bilirubin above ULN\n15. Triglycerides (TG) above 10 mmol\u002FL (above 900 mg\u002FdL)\n16. Serum creatinine above 1.4 mg\u002FdL in female patients and above 1.6 mg\u002FdL in male patients\n17. Patients already receiving systemic steroids, monoclonal antibodies or other immunosuppressive medications at the time of presentation\n18. Inability to comply with the regulations to avoid conception within 28 days after enrollment\n19. Admission to ICU prior to randomization\n20. Immediate need for intubation\n21. Imminent death\n22. Clinical team refusal\n23. Participation in other drug clinical trials (this criterion will be discussed with the PI)\n24. Reaching \\>72h since hospital admission\n25. Pregnancy (positive pregnancy test) or breastfeeding (which is a contraindication to tocilizumab)",{"count":235,"type":21},60,[237],"PHASE2","Acute hypoxemic respiratory failure (AHRF) happens when the lungs are unable to absorb enough oxygen. The bloodstream is deprived of oxygen which can eventually lead to more severe conditions like multi-organ failure (MOF) and death. AHRF accounts for over 30% of patients to critical care units, thus novel treatments are sorely needed. Research has shown that blood levels of the inflammatory biomarker Interleukin-6 (IL-6) may be a reliable marker for predicting which patients with AHRF will progress into requiring intensive care unit (ICU) admission, MOF, and eventually death. IL-6 levels were shown to reliably peak several days before MOF, ICU admission, and death. Thus, the investigators believe that by identifying patients before the peak of their IL-6 levels, they will be able to administer early treatment to prevent the patient's condition from worsening. The aim of this study is to test the feasibility of a treatment strategy for AHRF based on IL-6 measurement in patients who are admitted to hospital care with AHRF.\n\nPatients who are eligible for the study will have their plasma IL-6 levels measured over 2 days. Patients with elevated IL-6 levels will be randomized into 1 of 3 treatment groups: standard of care only, standard of care plus a single IV infusion of Tocilizumab, or standard of care plus treatment with oral Dexamethasone for 10 days. Patients will then be observed till discharge or up to 28 days, and a follow-up phone interview will be conducted 6 months of the end of the observation period.",[27],"2026-01-05",{"date":242,"type":37},"2026-01-12",{"date":244,"type":37},"2025-10-20",{"date":246,"type":21},"2027-02-26",{"name":248,"class":44},"Lorenzo delSorbo",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":274},"100607478","inthyx--intubation-strategies-for-patients-with-acute-hypoxemic-respiratory-failure-100607478","NCT07189078","IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure","IntHyx","Inclusion Criteria:\n\n* Adult patient\n* Patient admitted to intensive care less than 24 hours ago\n* Acute respiratory failure with hypoxemia defined by either:\n\n  * Oxygen therapy ≥ 10 L\u002Fmin via high-concentration mask required for SpO2 ≥ 92%\n  * High-flow oxygen therapy with FiO2 ≥ 50% required for SpO2 ≥ 92%\n* Informed consent of the patient or a trusted relative (when the patient is unable to give consent)\n\nExclusion Criteria:\n\n* Acute hypercapnic respiratory failure (defined by PaCO2 \\> 45 mmHg)\n* Cardiogenic pulmonary edema\n* Exacerbation of chronic respiratory disease\n* Respiratory failure requiring long-term oxygen therapy\n* Neuromuscular disease\n* Glasgow Coma Scale score ≤ 12\n* Decision to intubate immediately\n* Invasive mechanical ventilation within the previous 7 days\n* Treatment limitation decisions for intubation\n* Person deprived of liberty by judicial or administrative decision : Person undergoing compulsory psychiatric care, person subject to legal protection measures, Pregnant, breastfeeding, or parturient patient",{"count":257,"type":21},200,[24],"Acute hypoxemic respiratory failure requires endotracheal intubation and invasive mechanical ventilation in approximately 30-40% of cases, due to severe hypoxemia and\u002For clinical signs of acute respiratory distress. The primary objectives of invasive mechanical ventilation are to reduce respiratory effort and improve oxygenation. However, this intervention is also associated with both direct and indirect adverse effects, mainly linked to the need for sedation and often neuromuscular blockade. These include hemodynamic compromise, neuromuscular weakness, ventilator-induced lung injury, and infectious complications.\n\nAn ideal intubation strategy would therefore strike a balance: avoiding the risks of delayed intubation-such as refractory hypoxemia, excessive respiratory effort, and patient self-inflicted lung injury (P-SILI)-while limiting complications associated with invasive mechanical ventilation by withholding it in patients who might otherwise recover without. To date, the optimal strategy for achieving this risk-benefit balance remains uncertain.\n\nClinical practice suggests a broad consensus on the necessity of intubation when so-called safety criteria are met: severe hypoxemia (SaO₂\u002FFiO₂ ratio \\\u003C 88), marked respiratory distress (use of accessory muscles, thoracoabdominal paradox, respiratory rate \\> 40\u002Fmin), extra-respiratory manifestations of hypoxia (e.g., altered consciousness), and\u002For uncontrolled hemodynamic instability. Beyond these safety thresholds, however, debate persists. Some advocate for earlier intubation-a so-called liberal approach-triggered by predefined hypoxemia criteria (e.g., SpO₂\u002FFiO₂ \\\u003C 110), with the aim of limiting the deleterious consequences of sustained hypoxemia.\n\nIn routine practice, the criteria guiding intubation vary widely between clinicians and cannot be attributed to strong scientific evidence. This study therefore seeks to compare, in a randomized interventional design, the two main strategies currently applied across centers:\n\n* Liberal intubation strategy: prioritizing the prevention of organ dysfunction related to hypoxemia (notably hypoxic cardiac arrest) and the risk of P-SILI.\n* Restrictive intubation strategy: prioritizing the reduction of invasive mechanical ventilation use, with the goal of minimizing ventilation-related harm and its associated therapeutic burden.",[27],[262,263],"Randomization","Intubation","2025-12-26",{"date":266,"type":37},"2025-12-29",{"date":268,"type":37},"2025-12-13",{"date":270,"type":21},"2027-03",{"name":272,"class":273},"University Hospital, Angers","OTHER_GOV",9,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100614616","early-biological-and-mechanical-profiling-in-sepsis-associated-ards-100614616","NCT07281911","Early Biological and Mechanical Profiling in Sepsis-Associated ARDS","Characterization of Early Biological and Mechanical Profiles in Sepsis-Associated ARDS for Studying Compartamentalization (Serial Bronchoalveolar Lavage and Plasma Biomarkers) to Identify Inflammatory and Hybrid Subphenotypes","EARLY-SARDS","Inclusion Criteria:\n\n* Age ≥18\n* ARDS diagnosis per Berlin definition\n* Sepsis per Sepsis-3 criteria\n* Invasive mechanical ventilation\n* Expected to remain intubated ≥72 hours\n* Consent from surrogate\n\nExclusion Criteria:\n\n* Contraindications to bronchoscopy\u002FBAL\n* Refractory hemodynamic instability\n* Pregnancy\n* Pulmonary transplant patients\n* Surrogate declines participation",{"count":284,"type":21},180,"Sepsis-associated acute respiratory distress syndrome (ARDS) is one of the deadliest and most biologically heterogeneous forms of respiratory failure. Despite uniform diagnostic criteria, patients with septic ARDS show wide variability in inflammatory intensity, alveolar epithelial and endothelial injury, alveolar fluid composition, ventilatory mechanical properties, and clinical evolution. Early identification of these differences may enable better prognostication and more precise treatment.\n\nThis prospective observational study aims to deeply characterize the earliest phases of septic ARDS by integrating serial bronchoalveolar lavage (BAL) at 0, 24 and 72 hours with parallel plasma biomarker profiling and detailed mechanical ventilation data. This design captures the evolving biological and physiological landscape of septic ARDS during its most dynamic window. The central goal is to identify systemic, alveolar, and hybrid bio-mechano-inflammatory subphenotypes that can inform personalized approaches to support, risk stratification, and future interventional trials.",[27,287,288],"Sepsis","ARDS (Acute Respiratory Distress Syndrome)","2025-12-02",{"date":291,"type":37},"2025-12-15",{"date":293,"type":21},"2026-03-01",{"date":295,"type":21},"2027-11-01",{"name":297,"class":44},"Hospital Universitari Vall d'Hebron Research Institute",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":45},"100608609","peep-induced-effects-on-respiratory-drive-and-effort-100608609","NCT07203781","PEEP-induced Effects on Respiratory dRivE and EFfort","Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study","REEF","Inclusion Criteria:\n\n* Age \\> 18 years\n* Acute hypoxemic respiratory failure (AHRF) with a PaO2\u002FFiO2-ratio ≤ 200\n* Patient on invasive assisted mechanical ventilation in pressure support mode exhibiting valid inspiratory efforts (occlusion pressure \\> 5 cmH2O).\n\nExclusion Criteria:\n\n* Pre-existent neuromuscular disease\n* History of chronic respiratory failure requiring long-term oxygen therapy\n* Muscle paralysis\n* Pneumothorax\n* Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)\n* Contra-indications for EAdi or oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known\u002Fsuspected varices).",{"count":307,"type":21},20,[24],"Rationale:\n\nIn patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. While spontaneous breathing improves gas exchange and limits diaphragm atrophy, strong inspiratory efforts may worsen lung and diaphragm injury. Balancing these factors requires refined and tailored strategies, such as the modulation of PEEP. However, the impact of PEEP on neural respiratory drive and inspiratory effort is very heterogenous, and these two entities have only been studied separately in limited subsets of patients and healthy subjects. Additionally, it remains unclear whether the major determinant of PEEP-induced changes in respiratory drive and effort is represented by variations in diaphragm geometry, lung compliance, or by the presence of expiratory muscles recruitment, which may counteract its effect.\n\nObjective:\n\nThe primary objective is to determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation. The secondary objective is to determine the major physiological contributors to PEEP-mediated changes in diaphragm neuromechanical efficiency.\n\nStudy design: Prospective, physiological study. Study population: Invasively mechanically ventilated adult patients admitted to the ICU.\n\nIntervention:\n\nFor each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected.\n\nMain study parameters\u002Fendpoints:\n\nThe primary outcome of the study will be the evaluation of PEEP-mediated changes in diaphragm neuromechanical efficiency (NME).",[311,27],"ARDS (Moderate or Severe)",[313,314,315,316,317,318,319,320,321],"PEEP","effort","drive","PSV","pressure support ventilation","AHRF","ARDS","diaphragm","NME","2025-11-14",{"date":324,"type":37},"2025-11-17",{"date":326,"type":37},"2025-09-02",{"date":328,"type":21},"2026-09",{"name":330,"class":44},"Radboud University Medical Center",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100404354","phase-4-efficacy-of-dexamethasone-in-patients-with-acute-hypoxemic-respiratory-failure-caused-by-infections-100404354","NCT04545242","Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions","Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)","DEXA-REFINE","Inclusion Criteria:\n\n* age 18 years or older;\n* intubated and mechanically ventilated;\n* acute onset of AHRF (as defined by a PaO2\u002FFiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2\u002FFiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2\u002FFiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.\n* Pulmonary or systemic infectious etiology of AHRF.\n\nExclusion Criteria:\n\n* Patients with a known contraindication to corticosteroids,\n* Patient included in another therapeutic clinical trial\n* Lack of informed consent",{"count":340,"type":21},980,[342],"PHASE4","Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.\n\nMethods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg\u002Fd x 10 days or 20 mg\u002Fd x 5 days followed by 10 mg\u002Fd x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.",[27],[346,319,214,347],"Acute respiratory failure","Infection","2025-08-20",{"date":350,"type":37},"2025-08-26",{"date":352,"type":37},"2021-07-06",{"date":354,"type":21},"2026-12-30",{"name":356,"class":44},"Dr. Negrin University Hospital",40,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":366,"studyType":56,"phases":4,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":45},"100450821","endotyping-prehospital-de-novo-acute-hypoxemic-respiratory-failure-100450821","NCT05150483","EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure","EPIPHANY","Inclusion Criteria:\n\n* Adult patients (aged \\>18 years) presenting in the emergency department\n* De novo acute hypoxemic respiratory failure (requiring oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more)\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Not admitted to the hospital\n* Postoperative acute respiratory failure (within one week from surgery)\n* Chronic hypoxemic respiratory failure (requiring long term oxygen therapy at home)\n* Hypercapnic respiratory failure\n* Transferred from another hospital or facility\n* Pregnant women\n* Admitted to the hospital purely to facilitate comfort care\n* Lack of informed consent",{"count":181,"type":21},"28 Days","We attempt to perform dynamic endotyping of critically ill patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). We also attempt to identify what clinical, radiological, physiological and biological variables collected early in the course of AHRF correlate with subsequent mortality and\u002For persistent severe hypoxemia.",[27,369],"Acute Respiratory Distress Syndrome",[371,372,373,374,375,376,377],"critical illness","intensive care unit","endotypes","phenotypes","emergency department","trajectory","mechanical ventilation","2025-08-04",{"date":380,"type":37},"2025-08-07",{"date":382,"type":37},"2021-12-10",{"date":384,"type":21},"2026-04-30",{"name":386,"class":44},"Evangelismos Hospital",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":410},"100524148","weaning-protocol-for-high-flow-nasal-oxygen-therapy-in-intensive-care-100524148","NCT06104956","Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care","Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial","HiFloWEAN","Inclusion Criteria:\n\n* Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2\u002FFiO2 ratio \\\u003C300 mmHg)\n* Treated with HDNO for at least 24 hours in an intensive care unit or continuous care unit\n* Treated with HFNO with a flow rate ≥ 50L\u002Fmin and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion\n* With a ROX index (SpO2\u002FFiO2\u002FRespiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).\n* Had a blood gas test under HFNO within 24 hours of inclusion\n* Participant covered by or entitled to social security\n* Informed consent signed by the patient or its relatives if the patient is incapable; this consent must then be confirmed by the patient as soon as possible\n\nExclusion Criteria:\n\n* Presence of a patient included in the study and not weaned off HFNO in the sector managed by the nurse of the patient assessed for eligibility\n* Concomitant non-invasive ventilation treatment\n* Use of HFNO within 7 days of extubation\n* Chronic obstructive pulmonary disease (Gold grade 3 or 4)\n* Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure\n* Diffuse interstitial lung disease as a medical history\n* Patient with long-term non-invasive ventilation with external positive pressure\n* Patient on long-term oxygen therapy at home\n* Pregnant women, women in labour and breastfeeding mothers\n* Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.\n* Minor\n* Adult subject to a legal protection measure (guardianship, curators, person under court protection)\n* Patient with a medical decision not to intubate\n* Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays","90 Years",{"count":397,"type":21},370,[24],"High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.\n\nThe main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.\n\nThis is a open-label multicentre randomised controlled trial conducted in two parallel groups.\n\nThe primary endpoint is the success rate at Day 7, with success defined as \"definitive\" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.\n\nThe weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.",[27,401],"High-flow Nasal Oxygen Therapy","2025-07-25",{"date":404,"type":37},"2025-07-30",{"date":406,"type":37},"2024-02-17",{"date":270,"type":21},{"name":409,"class":44},"University Hospital, Tours",11,{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":45},"100594480","adiposity-distribution-in-acute-respiratory-failure-100594480","NCT07019987","Adiposity Distribution in Acute Respiratory Failure","Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure","Inclusion Criteria:\n\n* AHRF with PaO2\u002FFiO2 \\\u003C= 300 mmHg) intubated for less than 72 hours\n* Presence of an arterial line for blood gas measurement and blood pressure monitoring\n* 18 years or older\n\nExclusion Criteria:\n\n* Suspected pregnancy, pregnancy or less than six weeks postpartum\n* Younger than 18 years or older than 80 years.\n* Subject enrolled in another interventional research study\n* Presence of pneumothorax\n* Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator\n* Preexisting chronic lung disease or pulmonary hypertension\n* Acute cardiac failure causing pulmonary edema\n* Past medical history of lung malignancy or pneumonectomy, or lung transplant\n* Hemodynamic instability, defined as:\n\n  * Persistent systolic blood pressure \\\u003C90 mmHg and\u002For \\>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* Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury\n* Extracorporeal life support","80 Years",{"count":207,"type":21},[24],"Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution.\n\nTwo common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions.\n\nThis study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments..\n\nPatients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.",[27,423],"Obesity",[425,426,427,428,377,429,430],"acute hypoxemic respiratory failure","obesity","electrical impedance tomography","esophageal manometry","prone positioning","positive end expiratory pressure","2025-06-05",{"date":433,"type":37},"2025-06-13",{"date":435,"type":21},"2028-01-01",{"date":437,"type":21},"2030-06-30",{"name":439,"class":44},"Maurizio F. Cereda, MD",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":45},"100554053","pressure-muscle-index-and-threshold-of-over-assistance-during-pressure-support-ventilation-100554053","NCT06494085","Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation","PressUre-Muscle-index to Identify Patient's Desired Tidal Volume and the Threshold of Over-Assistance During Pressure Support Ventilation","PUMA","Inclusion Criteria:\n\n* \\>18 y.o.\n* Invasively ventilated in Intensive Care Unit.\n* Diagnosed with acute hypoxemic respiratory failure (P\u002FF\\\u003C300 mmHg).\n* Breathing on pressure support ventilation.\n\nExclusion Criteria:\n\n* \\\u003C18 y.o.\n* Contraindication for Electrical Impedence Tomography monitoring (e.g. pacemaker, burns, or - wounds limiting electrode placement).\n* Severe and previously diagnosed neurological and neuromuscular disease.\n* Psychomotor agitation (Sedation Agitation Scale \\> 4).",{"count":307,"type":21},"Pressure support ventilation (PSV) is used to assist the breathing of the intubated patient with some pressure from the ventilator. This support aims at avoiding excessive inspiratory effort, while ensuring a certain degree of training of the patient's inspiratory muscle. Avoiding both minimal and excessive assistance is thus important for the optimal care of the intubated patient ensuring a lung and diaphragm protective ventilation with the goal to liberate the patient from the ventilator as soon as possible.\n\nRecently pressure-muscle-index (PMI), an index of inspiratory effort easy to be measured on the ventilator screen, has been proposed to avoid excessive assistance in PSV. This will be the first prospective study testing the effects of setting pressure support based on PMI to avoid excessive assistance on patients recovering from acute lung injury (acute hypoxemic respiratory failure).",[27],[452,453,454,455],"Mechanical Ventilation","Intensive Care Unit","Pendelluft","Pressure Support Ventilation","2025-05-15",{"date":458,"type":37},"2025-05-20",{"date":460,"type":37},"2024-10-04",{"date":462,"type":21},"2026-02-28",{"name":464,"class":44},"Unity Health Toronto",{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":480,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":45},"100588071","eit-guided-ventilator-settings-in-ahrf-100588071","NCT06936618","EIT-Guided Ventilator Settings in AHRF","Using Electrical Impedance Tomography-Guided Ventilator Settings to Reduce Mechanical Power in Acute Hypoxemic Respiratory Failure : An Exploratory Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with acute hypoxemic respiratory failure within 48 hours\n* Expected to require invasive mechanical ventilation ≥ 48 hours\n* On mechanical ventilation within 24 hours\n* Deep sedation and neuromuscular blockade\n\nExclusion Criteria:\n\n* Pregnancy\n* Body mass index (BMI) \\> 40 kg\u002Fm2\n* Contraindications to using electrical impedance tomography, including\n* Presence of a pacemaker or automatic implantable cardioverter-defibrillator (AICD)\n* Inability to place the belt due to presence of surgical wounds dressing, thoracic or spinal cord trauma, recent thoracic surgery, etc.\n* High risk for PEEP titration\n* Hemodynamic instability defined as mean arterial pressure \\\u003C 65 mmHg despite optimization of fluid status and\u002For use of vasopressors\n* Unstable cardiac arrhythmias\n* Presence of lung bullae greater than 2 cm in diameter, identified on chest X-ray\n* Presence of pneumothorax or pneumomediastinum\n* Right-sided heart failure or severe pulmonary hypertension\n* Neurologic conditions associated with a risk of intracranial hypertension\n* Use of extracorporeal membrane oxygenation (ECMO)\n* Severe chronic respiratory disease, defined as follows: requiring home oxygen therapy, or previous lung function showing (FEV1 less than 20 ml\u002Fkg PBW, or FEV1\u002FFVC less than 50% predicted value), or chronic hypercapnia (PaCO2 greater than 45 mmHg) and\u002For chronic hypoxemia (PaO2 less than 55 mmHg) on FIO2 = 0.21, or radiographic x-ray evidence of any chronic over-inflation or chronic interstitial infiltration, or chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (unable to climb stairs or perform household duties, secondary polycythemia, severe pulmonary hypertension with mean pulmonary arterial pressure greater than 40 mmHg)\n* Decision to withhold life-sustaining treatment or palliative care.\n* Moribund status with an expected survival of less than 24 hours.\n* Refusal to provide informed consent",{"count":473,"type":21},17,[24],"This exploratory study aims to investigate the effect of Electrical Impedance Tomography (EIT)-guided ventilator settings on mechanical power in patients with acute hypoxemic respiratory failure (AHRF), including both ARDS and non-ARDS conditions. Mechanical power, a key factor associated with ventilator-induced lung injury (VILI), will be measured before and after EIT-guided PEEP titration. The study will evaluate feasibility and changes in lung mechanics, gas exchange, and EIT parameters. A total of 17 patients requiring invasive mechanical ventilation will be enrolled at Siriraj Hospital, Mahidol University.",[27,211,477,478,479],"Mechanical Power","Ventilator Induced Lung Injury","Electrical Impedance Tomography (EIT)",[481],"Acute Hypoxemic Respiratory Failure; Electrical Impedance Tomography; Mechanical Power, Ventilator-induced lung injury","2025-04-22",{"date":484,"type":37},"2025-04-27",{"date":486,"type":37},"2024-12-17",{"date":488,"type":21},"2026-12",{"name":490,"class":44},"Mahidol University",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100335022","the-effects-of-music-therapy-on-adult-patients-requiring-mechanical-ventilation-in-the-icu-100335022","NCT03642002","The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU","Inclusion Criteria:\n\n* Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation\n* Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Identified hearing disorder\n* Prior history of chronic respiratory failure requiring mechanical ventilation\n* RASS score of -4, or -5\n* Active seizures, or status epilepticus\n* Cardiac arrest\n* Coma\n* End of life\n* More than 2 vasopressors",{"count":498,"type":21},178,[24],"While most studies in the medical literature that indicate \"music\" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and\u002For its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.",[369,27,502],"Acute Hypercapnic Respiratory Failure",[504,505,506],"music therapy","song of kin","music medicine","2025-04-07",{"date":509,"type":37},"2025-04-09",{"date":511,"type":37},"2018-12-12",{"date":513,"type":21},"2028-12",{"name":515,"class":44},"Icahn School of Medicine at Mount Sinai",3,{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":540},"100516666","pilot-physiological-evaluation-of-an-investigational-mask-with-expiratory-washout-100516666","NCT06007495","Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.","Inclusion Criteria:\n\n* No indication of intubation upon evaluation by physician in the next 2 hours\n* Fits the investigational mask\n\nSpecific for hypercapnic patients 1 of the following criteria\n\n* Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;\n* Patient admitted to hospital with ARF with one criteria for NIV among the following:\n\n  * Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) \\> 45 millimeters of mercury (mmHg) and pH \\\u003C 7.38) or\n  * Post-extubation period within 48 hours, in patients with high risk of re-intubation\n\nSpecific for hypoxemic patients\n\n1 of the following criteria\n\n* Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;\n* Hypoxemic respiratory failure without hypercapnia requiring NIV or;\n* Conventional oxygen therapy (COT) \\> 6 liters per minute (L\u002Fmin) with peripheral oxygen saturation (SpO2) \\\u003C 92%\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Inability to provide informed consent\n* Infectious isolation\n* Facial deformity, burns or morphology that prevents adequate mask placement\n* Claustrophobia\n* Nausea\n* Presence of nasogastric tube\n* Pneumothorax\n* Confusion or loss of consciousness\n* Severe upper gastro-intestinal bleeding\n* Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results",{"count":524,"type":21},32,[24],"The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are:\n\n* Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask\n* How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask.\n\nParticipants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:\n\n* Single-limb NIV with investigation mask (with expiratory washout)\n* Single-limb NIV with conventional mask\n* Dual-limb NIV with conventional mask",[502,27],[529],"Non-invasive Ventilation","2025-03-12",{"date":532,"type":37},"2025-03-14",{"date":534,"type":37},"2024-05-06",{"date":536,"type":21},"2025-12",{"name":538,"class":539},"Fisher and Paykel Healthcare","INDUSTRY",2,{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":45},"100577259","effects-of-face-mask-continuous-positive-airway-pressure-vs-noninvasive-ventilation-vs-high-flow-nasal-oxygen-on-intubation-free-survival-in-acute-hypoxemic-respiratory-failure-the-tripod-randomized-clinical-trial-100577259","NCT06795971","Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intubation-free Survival in Acute Hypoxemic Respiratory Failure: the TRIPOD Randomized Clinical Trial","TRIPOD","Inclusion Criteria:\n\n1. Age≥18 yrs;\n2. A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hg or less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 or less (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or (2) high-flow nasal cannula at 30L\u002Fmin or higher, or (3) standard oxygen with oxygen flow rate of at least 10 L\u002Fmin;\n3. Sign informed consent.\n\nExclusion Criteria:\n\n1. Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.\n2. Previous bout of mechanical ventilation during index hospitalization.\n3. Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.\n4. Moderate to severe cardiac insufficiency (New York Heart Association class \\>II or left ventricular ejection fraction\\\u003C50%) or cardiogenic pulmonary edema.\n5. Hemodynamic dysfunction, defined as vasopressor dose \\> 0.3 µg\u002Fkg\u002Fmin of norepinephrine-equivalent to maintain systolic blood pressure \\> 90 mm Hg.\n6. Impaired consciousness with a Glasgow coma score ≤ 12.\n7. Patients with urgent need for intubation, including respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support.\n8. Patients with contraindication to NIV according to the French consensus conference, patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, upper airway obstruction, hematemesis or severe facial trauma, thoracic or abdominal surgery in the previous 7 days.\n9. A do-not-intubate order at time of inclusion.\n10. Pregnancy.",{"count":549,"type":21},1300,[24],"Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.",[27,553,554,555],"High-Flow Nasal Oxygen Therapy","Noninvasive Ventilation","Continuous Positive Airway Pressure (CPAP)","2025-02-24",{"date":558,"type":37},"2025-02-26",{"date":560,"type":37},"2025-01-23",{"date":562,"type":21},"2027-12-31",{"name":564,"class":44},"Southeast University, China",{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":540},"100544876","closed-loop-o2-use-during-high-flow-oxygen-treatment-of-critical-care-adult-patients-cloudhfot-100544876","NCT06374589","Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)","Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study","CLOUDHFOT","Inclusion Criteria:\n\n* Patient admitted to the ER\n* Requiring NHFO\n* Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician\n* Aged over 18 years\n* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation\n* In case that the consent is given by the relative, patient consent will be requested as soon as the patient will be able to provide informed written consent\n\nExclusion Criteria:\n\nPatients who fulfil any of the following exclusion criteria are not eligible for study participation:\n\n* Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation\n* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \\> 1 mg\u002Fh\n* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar)\n* Severe acidosis (pH ≤ 7.30)\n* Pregnant woman\n* Patients deemed at high risk for need of mechanical ventilation within the next 12 hours\n* Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease\n* Tracheotomized patient\n* Formalized ethical decision to withhold or withdraw life support\n* Patient under guardianship\n* Patient deprived of liberties\n* Patient included in another interventional research study under consent\n* Patient already enrolled in the present study in a previous episode of acute respiratory failure\n\nPost enrollment exclusion criteria\n\n* Apparition of a persistent low quality SpO2 signal\n* Need for an emergent intubation\n* Discharge from ER",{"count":574,"type":21},50,[24],"High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \\[Mauri et al, 2017; Möller et al, 2017\\].\n\nAs hyperoxia is considered not desirable \\[Barbateskovic et al, 2019\\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \\[O'Driscoll et al, 2017; Beasley et al, 2015\\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.\n\nA new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.\n\nA short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \\[Roca et al, 2022\\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.\n\nThe hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO.",[27,502,578,137],"Respiratory Depression",[580,581,582],"Acute respiratory failure (ARF)","HFNC","Closed-loop","2025-01-27",{"date":585,"type":37},"2025-01-28",{"date":587,"type":37},"2024-03-21",{"date":589,"type":21},"2026-05-30",{"name":591,"class":273},"Başakşehir Çam & Sakura City Hospital",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":45},"100549758","early-switch-from-controlled-to-assisted-ventilation-100549758","NCT06438198","Early Switch from Controlled to Assisted Ventilation","Unraveling the (patho)physiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation","SWITCH-SAFE","Inclusion Criteria:\n\n* 18 years old\n* Written informed consent from a legal representative\n* Mechanical ventilation via an endotracheal tube\n* Acute hypoxemic respiratory failure with PaO2\u002FFiO2 ratio \\\u003C 200 mmHg\n* Under continuous sedation with or without paralysis\n\nExclusion Criteria:\n\n* Expected mechanical ventilation duration of \\\u003C48 hours\n* Pure chronic obstructive pulmonary disease exacerbation\n* Pre-existent respiratory muscle disease\n* Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)\n* Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)\n* Known pregnancy\n* Anticipating withdrawal of life support and\u002For shift to palliation as the goal of care",{"count":307,"type":21},[24],"The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2\u002FFiO2 ratio \\\u003C 200 mmHg).\n\nThe intervention is that participants will be switched from controlled to assisted ventilation when PaO2\u002FFiO2 ratio \\> 200 mmHg.\n\nThe primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.",[27,452],[116,605,606,607,608],"Esophageal manometry","Controlled Mechanical Ventilation","Assisted Mechanical Ventilation","Respiratory Monitoring","2024-10-16",{"date":611,"type":37},"2024-10-18",{"date":613,"type":37},"2024-09-15",{"date":615,"type":21},"2026-05",{"name":617,"class":44},"Erasmus Medical Center",{"id":619,"slug":620,"hasResults":11,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":626,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":644},"100416826","rox-index-for-the-timing-of-intubation-in-nasal-high-flow-100416826","NCT04707729","ROX Index for the Timing of Intubation in Nasal High Flow","ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial","ROX-1","Inclusion Criteria:\n\n* All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.\n\n  * Criteria for initiation of NHF if they had a respiratory rate \\> 25 breaths\u002Fmin and\u002For pulse oximetry (SpO2) \\\u003C 92% while receiving standard oxygen administered through a facemask at 10 L\u002Fmn or more.\n  * Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Patients with indication for immediate intubation.\n* Patients treated with NHF for more than 1h prior to randomization.\n* Patients with do-not-intubate order.\n* Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).\n* Patients with no pulmonary infiltrates on chest X-ray\n* Patient with post-extubation AHRF.\n* Awake ECMO.\n* Pregnancy.\n* Refusal to participate or participation in another interventional study with the same primary outcome.","120 Years",{"count":628,"type":21},630,[24],"Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria.\n\nThe objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.",[27],[633,634,635],"High flow nasal cannula","Nasal high flow","High flow oxygen therapy","2024-08-12",{"date":638,"type":37},"2024-08-15",{"date":640,"type":37},"2020-12-09",{"date":642,"type":21},"2025-06-30",{"name":297,"class":44},12,{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":45},"100491147","physiological-effects-of-continuous-negative-external-pressure-for-acute-hypoxemic-respiratory-failure-100491147","NCT05675345","Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure","Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Acute hypoxemic respiratory failure\n* Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan\n* High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)\n* FiO2 ≥ 40%\n* SpO2 ≥ 92%\n\nExclusion Criteria:\n\n* Do-not-intubate order\n* Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)\n* Use of cuirass precluded, e.g. due to:\n\n  * Clinically prescribed prone positioning\n  * Tense ascites\n  * Severe abdominal pain\n  * Abdominal wound or surgery\n  * Pregnancy\n  * Agitated delirium\n* Prior intubation during hospital stay\n* Cardiogenic pulmonary edema\n* Exacerbation of asthma or COPD\n* Chronic lung disease, including:\n\n  * Interstitial lung disease\n  * Cystic fibrosis\n  * Lung mass, lung cancer, or metastasis to the lung\n  * Lung transplant recipient\n  * Any disease that requires home oxygen\n* Glasgow coma score \\\u003C 15\n* Chest tube, pneumothorax, or pneumomediastinum\n* Hemodynamic instability (mean arterial pressure \\\u003C 55 mmHg or norepinephrine-equivalent vasopressor requirement \\> 0.1mcg\u002Fkg\u002Fmin)\n* Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)\n* Unreliable pulse-oximetry tracing\n* Imminent intubation\n* Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study)\n* Attending physician refusal",{"count":307,"type":21},[24],"This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest\u002Fabdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).",[27],[657,658,377,659,660,661],"acute respiratory distress syndrome","noninvasive ventilation","oxygen inhalation therapy","atelectasis","high-flow nasal cannula","2024-02-29",{"date":664,"type":37},"2024-03-04",{"date":666,"type":37},"2024-02-28",{"date":668,"type":21},"2026-12-31",{"name":670,"class":44},"Columbia University"]