[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-distress-syndrome-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-distress-syndrome-adult":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,76,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100404367","phase-2-trial-of-therapeutic-hypothermia-in-patients-with-ards-100404367",false,"NCT04545424","Trial of Therapeutic Hypothermia in Patients With ARDS","Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients With ARDS","CHILL","Inclusion Criteria:\n\n1. endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;\n2. admitted to a participating ICU\n3. radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema\n4. P\u002FF ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P\u002FF ratio may be inferred from SpO2 values based on Table 3 from Brown et al as long as following conditions are met:\n\n   1. SpO2 values are 80-96%\n   2. SpO2 is measured ≥10 min after any change in FIO2\n   3. PEEP is ≥ 8 cm H2O\n   4. the pulse oximeter waveform tracing is adequate\n   5. the qualifying inferred P\u002FF ratio is confirmed 1-6h after initial determination.\n5. access to an LAR to provide consent.\n6. Criteria 3 AND 4 must be met within 72h of enrollment and randomization, not be fully explained by hydrostatic pulmonary edema, and must have occurred within 7 days of exposure to an ARDS-risk factor (including continuous exposure to persistent processes (e.g. sepsis, pneumonia, COVID-19).\n\n   * Patients may be enrolled and decision about randomization delayed if all criteria other than P\u002FF ratio ≤ 200 are met and then randomized if and when the P\u002FF ratio ≤200 (as long as this occurs within 72h of randomization). Patients on high flow nasal oxygen or non-invasive pressure ventilation may be consented if they meet criteria for starting the 72h ARDS window but may not be enrolled and randomized until they are intubated.\n\nExclusion Criteria:\n\n1. Missed moderate-severe ARDS window (\\>72hrs) - Window starts when patient is intubated with a qualifying P\u002FF ratio of ≤ 200 with PEEP ≥ 8 cm H2O or on high flow nasal oxygen with well-fitting nasal cannula with flow ≥ 40 LPM and FiO2 ≥ 0.65 or on non-invasive pressure ventilation with PEEP ≥ 8 cm H2O and FiO2 ≥ 0.6.\n2. Missed NMB window: (\\>48 hrs)\n3. Missed mechanical ventilation window (\\>7 days)\n4. Refractory hypotension (continuous infusion of \\>0.3 mcg\u002Fkg\u002Fmin of norepinephrine or equivalent dose of other vasopressors within 2 hours prior to randomization)\n5. Core temperature \\\u003C35°C for ≥6 hours while not receiving CRRT on day of randomization\n6. Significant, active bleeding (\\>3u blood products and\u002For surgical\u002FIR intervention) on day of randomization\n7. Platelets \\\u003C10K\u002Fmm3 (uncorrected) on day of randomization\n8. Active hematologic malignancy and not expected to survive 6 months\n9. Skin process that precludes cooling device\n10. Moribund, not likely to survive 72h\n11. Pre-morbid condition makes it unlikely that patient will survive 28 days\n12. Do Not Resuscitate status at time of randomization (excluding patients receiving full support EXCEPT CPR for cardiac arrest)\n13. Not likely to remain intubated for ≥48h\n14. Physician of record unwilling to participate\n15. Severe underlying lung disease\n\n    1. Needs \\> 2 LPM or \\>28% continuous home O2 (adjusted for altitude)\n    2. On BIPAP (except for OSA)\n    3. Prior lung transplantation\n16. Pregnant at time of randomization\n17. BMI consistently \\>50 kg\u002Fm2\n18. Known NYHA class IV heart disease\n19. Acute Coronary Syndrome (MI, unstable angina) within 30 days of randomization\n20. Cardiac arrest within 30 days of randomization with sequelae likely to increase mortality and\u002For time to ventilator liberation.\n21. Burns over \\>20% of the body surface\n22. Severe chronic liver disease (Child-Pugh score 12-15)\n23. Previously randomized in CHILL study\n24. Simultaneous enrollment in another inpatient interventional trial started during the current hospitalization.\n25. On ECMO during the current hospitalization.","ALL","18 Years","85 Years",{"count":21,"type":22},340,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \\~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over \\~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7.",[28],"Respiratory Distress Syndrome, Adult",[30,31],"ards","targeted temperature management","RECRUITING","2025-11-05",{"date":35,"type":36},"2025-11-10","ACTUAL",{"date":38,"type":36},"2021-06-29",{"date":40,"type":22},"2026-10-31",{"name":42,"class":43},"University of Maryland, Baltimore","OTHER",19,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100314024","phase-3-inhaled-dornase-alpha-to-reduce-respiratory-failure-after-severe-trauma-100314024","NCT03368092","Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma","A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit","TRAUMADORNASE","Inclusion Criteria:\n\n* Adult (\\>18) patient of either sex affiliated to the National Health Service\n\n  * Severe trauma patient (either blunt or penetrating), Injury Severity Score \\> 15\n  * Under mechanical ventilation for an expected duration \\> 48h\n  * Admitted in the ICU\n  * Signed informed consent from the patient's relative\n  * Patient equipped with an indwelling arterial catheter\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n\n  * Opposition from the patient or his\u002Fher relatives\n  * Protected major (Guardianship)\n  * Contraindication to the use of dornase alfa\n  * Known intolerance to dornase alfa",{"count":54,"type":22},500,[56],"PHASE3","Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).\n\nConsidering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).\n\nThe primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).\n\nThe secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:\n\n* an improvement in static lung compliance\n* a reduction in mechanical ventilation duration \u002F an increase in ventilation-free ICU days\n* a reduction in the length of ICU stay\n* a reduction in the hospital length of stay\n* a reduction in multi-organ failure\n* a reduction in ventilator-associated pneumonia (VAP)\n* a reduction in mortality at day 28",[59,28],"Multiple Trauma",[61,62,63,64,65],"severe trauma","acute respiratory distress syndrome","damage-associated molecular patterns","neutrophil extracellular traps","dornase alfa","2025-08-04",{"date":68,"type":36},"2025-08-08",{"date":70,"type":36},"2019-03-04",{"date":72,"type":22},"2027-12-01",{"name":74,"class":43},"University Hospital, Strasbourg, France",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":75},"100531715","the-efficacy-of-p01-guided-sedation-protocol-in-critically-ill-patients-receiving-invasive-mechanical-ventilation-a-randomized-controlled-trial-100531715","NCT06203405","The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital\n2. Age ≥18 years old\n3. Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)\n\nExclusion Criteria:\n\n1. Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients\n2. Patients receiving mechanical ventilation for \\>72 hours before enrollment\n3. Patients receiving neuromuscular blocking agents prior to randomization\n4. Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy\n5. Patients with severe metabolic acidosis (arterial pH \\\u003C7.2) who do not have a plan for renal replacement therapy\n6. Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases\n7. Post-cardiac arrest patients\n8. Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C\n9. Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs\n10. Pregnancy\n11. Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments\n12. Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment",{"count":83,"type":22},214,[85],"NA","This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.",[88,89,28,90,91],"Respiratory Failure","Critical Illness","Lung Injury","Mechanical Ventilation Complication",[93,94,95,96,97],"acute respiratory failure","sedation","respiratory drive monitoring","mechanical ventilation","intensive care unit","2025-05-19",{"date":100,"type":36},"2025-05-22",{"date":102,"type":36},"2023-12-22",{"date":104,"type":22},"2026-06-30",{"name":106,"class":43},"Siriraj Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100553691","high-flow-nasal-oxygen-for-acute-hypoxemic-respiratory-failure-in-the-emergency-room-100553691","NCT06489379","High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room","High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study","GLAMOUR","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* PaO2\u002FFiO2 ratio between 250 and 150 mmHg or SpO2\u002FFiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;\n* Respiratory rate(RR)≤35breaths\u002Fmin,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;\n* PaCO2 ≤ 45 mmHg;\n* Unilateral or bilateral infiltrate(s), as detected with chest radiography and\u002For computed tomography and\u002For with lung ultrasound not fully explained by effusions, atelectasis, or nodules\u002Fmasses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.\n\nExclusion Criteria:\n\n* Respiratory failure due to:\n\n  * Acute asthma or COPD exacerbation,\n  * Cardiac failure or fluid overload as primary cause of respiratory failure;\n* Unstable angina or ongoing acute myocardial infarction;\n* Acute respiratory acidosis with pH \\\u003C 7.35 and PaCO2 \\> 45 mmHg;\n* Hemodynamic instability and\u002For use of vasopressors\u002Finotropes;\n* Altered mental status (Kelly \\>3), see Figure 1;(18)\n* Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and\u002For burns, uncooperative patient, cranial\u002Fthoracic\u002Fabdominal open wounds);\n* Indications to urgent intubation performed according to the clinician in charge;\n* Body Mass Index \\> 35 kg\u002Fm2;\n* Pregnancy;\n* Patient's refusal to participate.",{"count":116,"type":22},234,[85],"The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.",[28],"NOT_YET_RECRUITING","2024-07-03",{"date":123,"type":36},"2024-07-05",{"date":125,"type":22},"2024-07",{"date":127,"type":22},"2026-07",{"name":129,"class":43},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]