[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ards-acute-respiratory-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ards-acute-respiratory-distress-syndrome":626},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,47,72,94,119,146,177,202,222,248,270,298,323,358,385,409,425,440,456,473,503,524,548,570,596],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645198","time-controlled-adaptive-ventilation-tcav-compared-with-conventional-ventilation-in-patients-with-moderate-to-severe-acute-respiratory-distress-syndrome-ards-secondary-to-community-acquired-pneumonia-100645198",false,"NCT07679802","Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients With Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia","Efficacy and Safety of Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Requiring Invasive Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia","EARLY-TCAV","Inclusion Criteria:\n\n* Intensive care unit hospitalisation for ARDS with a PaO₂\u002FFiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation\n* Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea\n* Onset of symptoms ≤ 7 days\n* Invasive ventilation initiated ≤ 24 hours\n* Affiliation to a social security program\n* Patient for whom written consent has been obtained from a trusted person or a family member, or inclusion in a situation of immediate life-threatening emergency\n\nExclusion Criteria:\n\n* Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)\n* Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)\n* Pneumothorax, drained or undrained, with a persistent pleural air leak\n* COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home\n* Circulatory support via VV-ECMO or VA-ECMO\n* Presence of a patent foramen ovale\n* Active limitation of therapies\n* Increased intracranial pressure\n* Sickle cell disease\n* Burns \\> 30%\n* Expected invasive mechanical ventilation for less than 48 hours\n* A person covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code\n* Pregnant or breastfeeding women\n* A not emancipated minor\n* Adults subject to legal protective measures (guardianship, conservatorship, judicial protection) or inability to give consent\n* Persons deprived of liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1","ALL","18 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"NA","ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to \"ventilation-induced lung injury\" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.\n\nEvaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.\n\nThe measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.\n\nThe TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.",[28],"ARDS (Acute Respiratory Distress Syndrome)",[30,31,32,33],"ARDS","APRV","TCAV","Invasive ventilation","NOT_YET_RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":22},"2026-10-01",{"date":42,"type":22},"2028-11-30",{"name":44,"class":45},"Central Hospital, Nancy, France","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100616550","real-time-algorithm-driven-ventilation-feedback-to-improve-lung-protective-ventilation-in-patients-with-ards-realvent-study-100616550","NCT07307066","Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)","REALVENT","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening\n* Initiation of invasive mechanical ventilation within the past 24 hours\n* PaO₂\u002FFiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂\u002FFiO₂ ≤ 235 with SpO₂ ≤ 97%\n* Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules\n* Respiratory failure not fully explained by cardiac failure or fluid overload\n* Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment\n\nExclusion Criteria:\n\n* Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening\n* Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours\n* Pregnancy\n* Known neuromuscular disease affecting spontaneous respiratory effort\n* Prisoners or individuals unable to provide informed consent or surrogate consent\n* Simultaneous enrollment in another interventional ICU study\n* Lack of digital infrastructure for real-time ventilator waveform acquisition","75 Years",{"count":56,"type":22},208,[25],"The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.",[28,60,61,62],"VILI (Ventilator-induced Lung Injury)","Respiratory Failure","Critical Illness","RECRUITING","2026-06-29",{"date":37,"type":38},{"date":67,"type":38},"2025-12-30",{"date":69,"type":22},"2027-02-28",{"name":71,"class":45},"Peking Union Medical College Hospital",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100644886","observational-non-interventional-biomarker-and-endotyping-study-100644886","NCT07675265","Observational, Non-interventional Biomarker and Endotyping Study","Observational Biomarker Study for the Evaluation of Response and Validation of Endotypes in Acute Respiratory Distress Syndrome","OBSERVE-ARDS","Inclusion Criteria:\n\n* Age ≥18 years\n* ARDS Diagnosis (New Global Definition of ARDS)\n* Timing: Acute onset within 7 days\n* Radiology: Bilateral pulmonary opacities\n* Hypoxia:\n\nNon-intubated ARDS: PaO2:FIO2\\\u003C300mmHg or SpO2:FIO2\\\u003C315 (if SpO2\\\u003C97%) on HFNO with flow of \\>30 L\u002Fmin or NIV\u002FCPAP with at least 5 cm H2O end-expiratory pressure; or Intubated ARDS: PaO2:FIO2\\\u003C300 mm Hg or SpO2:FIO2\\\u003C315 (if SpO2\\\u003C97%)\n\n* ICU admission\n* Enrolled within 72 hours of meeting inclusion criteria\n\nExclusion Criteria:\n\n• Primary cardiogenic pulmonary edema",{"count":81,"type":22},1200,"OBSERVATIONAL","The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop unsupervised, therapy-specific treatment-prediction algorithms over a 24 month period.",[28],"2026-06-23",{"date":35,"type":38},{"date":88,"type":22},"2026-07",{"date":90,"type":22},"2029-03",{"name":92,"class":93},"Prenosis, Inc.","INDUSTRY",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":46},"100635888","early-phase-1-a-single-dose-dose-escalation-clinical-trial-on-the-safety-tolerability-and-efficacy-of-lyophilized-powder-for-inhalation-of-recombinant-human-keratinocyte-growth-factor-2-rh-kgf-2-in-the-treatment-of-patients-with-acute-respiratory-distress-syndrome-100635888","NCT07558538","A Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n1. Aged ≥18 years and \\\u003C80 years, male or female.\n2. Definite diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition.\n3. Patients with PaO₂\u002FFiO₂ \\\u003C 200 mmHg and receiving invasive mechanical ventilation via endotracheal intubation.\n4. Diagnosis of ARDS confirmed no more than 72 hours prior to enrollment.\n5. No plan for parenthood within 1 year and agree to take effective contraceptive measures during the study period. Female participants of childbearing potential must have a negative serum pregnancy test.\n6. The subject fully understands the purpose of the study, as well as the nature, methods, and potential reactions of the investigational drug. The subject voluntarily signs the informed consent form to participate in the study and agrees to comply with the requirements of the study protocol. If the subject is unable to provide consent or has limited capacity to consent, consent must be obtained from the subject's legal guardian.\n\n   \\-\n\nExclusion Criteria:\n\n1. Use of inhaled pulmonary vasodilators (e.g., nitric oxide or prostaglandins).\n2. Current receipt or planned receipt of extracorporeal membrane oxygenation (ECMO) during the study period.\n3. Expected survival \\\u003C 3 months due to causes other than respiratory failure.\n4. Cerebrovascular or cardiovascular events within 3 months prior to study drug administration, including unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) \\\u003C 40%, or clinically significant arrhythmia or conduction abnormality.\n5. Inability to tolerate single-use bronchoscopic imaging catheter examination, including but not limited to the following: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction or unstable angina within 4-6 weeks prior to screening; severe cardiac dysfunction; uncorrectable bleeding tendency (platelet count \\\u003C 60 × 10⁹\u002FL), such as severe coagulation disorders, uremia, or severe pulmonary hypertension; severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae.\n6. History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product.\n7. Breastfeeding or pregnant women.\n8. Participation in any drug clinical trial within 3 months prior to enrollment.\n9. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.","80 Years",{"count":102,"type":22},24,[104],"EARLY_PHASE1","This study is a randomized, blank-controlled, open-label, single-dose, dose-escalation clinical study of rhKGF-2 in patients with ARDS.\n\nThe trial is designed with three dose groups (5 mg, 10 mg, and 15 mg), which will be escalated sequentially from the lowest dose group to the highest dose group. Each dose group will enroll 8 subjects, randomized in a 6:2 ratio according to the order of enrollment, to receive either the corresponding dose of rhKGF-2 (6 subjects) or serve as a blank control (2 subjects). Each subject will receive a single dose, administered once via a disposable bronchoscopic catheter.\n\nAll subjects will receive the trial intervention on top of standard ARDS treatment (see Concomitant Medications for details). Following the completion of drug administration, subjects will enter a 28-day follow-up period. Outcome measures include adverse events (AE), vital signs, laboratory parameters, oxygenation index (PFR), chest imaging changes, etc., to evaluate the safety, tolerability, and efficacy of the treatment.",[107,28],"ARDS (Moderate or Severe)",[28,109],"rh-KGF2","2026-06-09",{"date":112,"type":38},"2026-06-11",{"date":114,"type":38},"2026-05-14",{"date":116,"type":22},"2026-12-30",{"name":118,"class":45},"Shanghai Zhongshan Hospital",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":18,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":46},"100602558","lung-injury-is-one-of-the-primary-causes-of-morbidity-and-mortality-in-critically-ill-patients-these-patients-will-be-monitored-for-1-immune-cell-activation-2-blood-based-biomarkers-in-vitro-models-derived-from-these-samples-will-be-treated-with-novel-agent-pip-2-to-evaluate-its-efficacy-100602558","NCT07125079","Lung Injury is One of the Primary Causes of Morbidity and Mortality in Critically Ill Patients. These Patients Will be Monitored for: 1) Immune Cell Activation 2) Blood-based Biomarkers. In Vitro Models Derived From These Samples Will be Treated With Novel Agent PIP-2 to Evaluate Its Efficacy.","Blood-based Biomarkers of Acute Lung Injury\u002FAcute Respiratory Distress Syndrome","ALI\u002FARDS","Inclusion Criteria: ARDS patients with mild and moderate to severe ARDS. This will be based on PaO2\u002FFiO2 in the range of 100 mmHg (severe) and moderate (100-200 mm Hg) and mild (200-300 mm Hg) -\n\nExclusion Criteria: Pregnant women, children will be excluded.\n\n\\-","21 Years","90 Years",{"count":130,"type":22},36,"Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) is a condition where high levels of inflammation damage the lung. This is a highly morbid condition with no specific pharmacologic therapies. The investigators posit that ARDS is caused due to an exaggerated activation of immune cells and that blockade of this activation may reduce lung damage\u002Finjury and help in ARDS management and possibly recovery. To test this hypothesis, the investigators propose to generate an in vitro immune cell model and test a novel (reactive oxygen species) blocking agent PIP-2 on this model. The investigating team will obtain blood of ARDS patients and isolate immune cells (specifically peripheral blood mononuclear cells or PBMC) and monitor the activation of these cells and their blockade by PIP-2. This is entirely an in vitro study.",[28],[134,30,135,136,137],"ROS","PIP-2","immune cells","peripheral blood mononuclear cells",{"date":139,"type":38},"2026-06-10",{"date":141,"type":38},"2025-05-20",{"date":143,"type":22},"2027-11-20",{"name":145,"class":45},"University of Pennsylvania",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":157,"studyType":82,"phases":4,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":46},"100643020","balance-ards-deconvolution-by-bronchoalveolar-lavage-multiomics-and-radiomics-100643020","NCT07633366","BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics and Radiomics","Check the BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics Profiling and Radiomics","BALance","Inclusion Criteria:\n\n* male and female\n* aged 18 years or over\n* signed consent form\n* depending on the study group: Confirmed ARDS according to the Berlin criteria (see below, Groups B and D) Confirmed severe CAP requiring mechanical ventilation and intensive care (see below, Groups B and C) Ventilated patients without signs of ARDS (see below, Group E)\n\nExclusion Criteria:\n\n\\- under 18 years of age",true,{"count":156,"type":22},130,"4 Years","Acute respiratory distress syndrome (ARDS) is a major contributor to ICU mortality and is characterised by hypoxaemia and pulmonary oedema. Pathomechanisms include barrier breakdown, immunopathology, haemostatic derailment and dysbiosis; however, the actual sequence of events and how they cumulatively lead to lung failure remains unclear. Although ARDS is frequently triggered by pneumonia, it can also occur as a result of trauma, aspiration or non-pulmonary causes. Importantly, ARDS is highly heterogeneous; growing evidence points to aetiology-specific pathomechanisms - a circumstance that explains why attempts to develop specific drugs or timely diagnostic markers have so far failed.\n\nA comprehensive analysis of key microenvironmental and haemostasis-related parameters of the lung, combined with multidimensional quantitative image features derived from chest CT scans (radiomics), will enable us to i) identify ARDS phenotypes with different biological characteristics and ii) generate new hypotheses regarding aetiology- or subgroup-specific mechanisms, molecular markers and therapeutic options.\n\nOur approach is based on ICU management of our patients guided by bronchoalveolar lavage fluid (BALF). Together with previously sampled cases and new samples collected as part of this study, our cohort will consist of patients with i) COVID-19-associated ARDS, ii) ARDS associated with other viral pneumonia, iii) ARDS associated with bacterial pneumonia, and iv) ARDS of non-pulmonary origin. Bacterial and fungal co-infections and superinfections are recorded in all patients and taken into account in the stratification. Patients with pneumonia without ARDS, as well as ventilated patients without underlying lung disease, serve as controls. To characterise the microbial lung microenvironment, the investigators combine data from routine microbiological diagnostics with microbiome sequencing and metabolomics. In addition, the investigators conduct comprehensive and longitudinal immune and haemostatic profiling by regularly analysing immune cells, cytokines and parameters of immune thrombosis in BALF and blood. Multi-omics integration then identifies phenotypic subgroups by merging all multimodal datasets - including radiomics. Selected samples from identified clusters are then further characterised using single-cell sequencing to uncover specific features\u002Fmarkers and pathomechanisms of the respective ARDS subtypes.\n\nAlthough it is clear that the pathogenesis of ARDS is multifactorial, comprehensive studies that integrate all relevant parameters are rare. Radiomics is increasingly recognised as a powerful tool for capturing the clinical status of ARDS in detail; however, to date, this imaging data has not been systematically linked to other omics readouts. The investigators aim to bridging this gap by conducting a thorough investigation across various ARDS aetiologies in the present study, incorporating all identifiable key factors.\n\nOur interdisciplinary team comprises basic immunologists, infectious disease and computational biologists, as well as clinicians with expertise in ARDS, infectious diseases, immunothrombosis and radiology.",[28],[30,161,162,163,164,165,166,167],"BALF","COVID-19","Influenza","Co-Infection","Pneumonia","viral","bacterial","2026-06-02",{"date":170,"type":38},"2026-06-08",{"date":172,"type":22},"2026-06-01",{"date":174,"type":22},"2030-06-01",{"name":176,"class":45},"Medical University of Vienna",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100640581","titration-of-positive-end-expiratory-pressure-comparison-between-manual-thoracic-or-abdominal-compression-and-electrical-impedance-tomography-100640581","NCT07623590","Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography","TICTAC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Moderate to severe ARDS according to the Berlin criteria\n* Patient receiving sedation and continuous curarization\n* Free and informed consent from the patient or their loved one\n\nExclusion Criteria:\n\n* ECMO\n* Pneumothorax\n* Chest trauma in the last 3 months\n* Uncontrolled shock (noradrenaline \\> 5 mg\u002Fh)\n* Pregnant or breastfeeding woman\n* Protected adult within the meaning of the law\n* Lack of social security\n* Patient under AME",{"count":185,"type":22},30,[25],"Patients with acute respiratory distress syndrome are placed on mechanical ventilation, and the adjustment of ventilator parameters is an important step in their care, in particular positive expiratory pressure, applied at the end of breathing.\n\nThe goal of this study is to learn if continuous anterior chest compression works as well as electrical impedance tomography for positive expiratory pressure titration.\n\nResearchers will compare the two methods for each patient, in a randomly determined order : continuous anterior chest compression and electrical impedance tomography.\n\nParticipants will :\n\n* have a pep titration with both techniques\n* be included in the study for 28 days",[28],[190,30,191],"EIT","PEEP","2026-05-29",{"date":194,"type":38},"2026-06-03",{"date":196,"type":38},"2025-04-07",{"date":198,"type":22},"2027-05-05",{"name":200,"class":45},"Centre Hospitalier Saint Joseph Saint Luc de Lyon",2,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":100,"enrollmentInfo":209,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":220,"locationsCount":46},"100641064","eit-evaluation-of-the-impact-of-inhaled-nitric-oxide-on-ventilationperfusion-mismatch-in-ards-patients-receiving-noninvasive-respiratory-support-100641064","NCT07617298","EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation\u002FPerfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support","EIT Evaluation of the Impact of Inhaled Nitric Oxide on Ventilation\u002FPerfusion Mismatch in ARDS Patients Receiving Noninvasive Respiratory Support: A Prospective Physiological Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender unlimited;\n2. Non invasive ventilation (NIV) with PEEP or CPAP ≥ 5 cmH2O or nasal high flow oxygen therapy (hfnc) with flow rate ≥ 30 l\u002Fmin met the diagnostic criteria of non intubated ARDS according to the new global definition of ARDS: pao2\u002Ffio2 ≤ 300MMHG or spo2\u002Ffio2 ≤ 315 (SpO2 ≤ 97%);\n3. Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;\n4. Patients with spontaneous breathing and clear consciousness can cooperate with instructions and hold breath for ≥ 8s;\n\nExclusion Criteria:\n\n1. There are signs of worsening respiratory failure requiring immediate intubation: respiratory rate \\> 40 times \u002F min with severe use of auxiliary respiratory muscles or contradictory breathing, or Paco ₂ \\> 50 mmHg and pH \\\u003C 7.25;\n2. Hemodynamic instability or the presence of refractory shock; That is, the vasoactive drugs increased by more than 30% within 6 hours, or the norepinephrine dose exceeded 0.5 μ g \u002Fkg\u002Fmin;\n3. There are contraindications to EIT monitoring, such as thoracic implantable defibrillator \u002F pacemaker, large area of severe skin damage on the chest, serious allergy to electrode patches, etc;\n4. There are contraindications to the use of iNO: such as severe left ventricular dysfunction, active bleeding, etc;\n5. Patients with intracranial hypertension, severe arrhythmia or digestive tract obstruction;\n6. Pneumothorax and massive pleural effusion were not treated;\n7. Chronic kidney disease;\n8. Pregnant or lactating women;\n9. Participating in other studies;\n10. The investigator judged that there were any other circumstances not suitable for participation in this study. -",{"count":210,"type":22},40,"This study aimed to quantitatively evaluate the immediate effect of inhaled nitric oxide on the ventilation \u002F perfusion ratio in ARDS patients receiving nasal high flow oxygen therapy or noninvasive ventilation using electrical impedance tomography.",[28],[30,214],"inhaled nitric oxide","2026-05-24",{"date":172,"type":38},{"date":35,"type":22},{"date":219,"type":22},"2027-12-31",{"name":221,"class":45},"Ming Zhong",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":154,"sex":18,"minAge":19,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":201},"100627510","phase-1-clinical-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-ht31-1-for-treating-ards-100627510","NCT07449572","Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS","A Phase 1\u002F2A, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 (hCitH3-mAb) in Healthy Volunteers and in Patients With Mild-to-Moderate ARDS: Part A (Healthy Volunteers)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age 18 to 65 years old, inclusive, at the time of consent.\n2. Able and willing to provide written informed consent and to comply with all study procedures and requirements.\n3. Healthy as determined by medical history, physical examination, and baseline investigations. No clinically significant abnormalities on physical exam.\n4. Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm², inclusive.\n5. Vital signs and 12-lead ECG without clinically significant abnormalities, in the investigator's judgment, at screening (e.g., resting blood pressure and heart rate within normal limits).\n6. Screening clinical laboratory tests (hematology, chemistry, liver and kidney function, etc.) within normal ranges or not clinically significant as judged by the investigator.\n7. Female volunteers must be of non-childbearing potential (either surgically sterile by tubal ligation, bilateral oophorectomy or hysterectomy at least 6 months prior, or postmenopausal for ≥1 year) OR if of childbearing potential must agree to use 2 approved effective contraceptions from screening through at least 90 days after the last dose. Acceptable methods include hormonal contraception, intrauterine device, or barrier methods with spermicide.\n8. Male volunteers with partners of childbearing potential must agree to use 2 approved effective contraception (e.g., condom plus spermicide) from screening through 90 days after their dose of study drug.\n9. Able to communicate well with the investigator and comply with study requirements (e.g., availability for all follow-up visits).\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. History of any severe allergy or hypersensitivity to drugs, or known hypersensitivity to any monoclonal antibody (including prior biologic therapy reactions).\n2. Known autoimmune disease or immunodeficiency condition, including a positive test for HIV at screening.\n3. Active or chronic viral hepatitis infection: positive screening test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody.\n4. History of tetanus infection, or receipt of tetanus toxoid vaccine within 6 months prior to first dose of study drug. (Rationale: CitH3 is associated with NETs, and recent tetanus immunization may confound immune status or antibody responses).\n5. Receipt of any live attenuated vaccine within 4 weeks prior to first dose, or any inactivated vaccine within 2 weeks prior to first dose. (This is to avoid confounding immune activation or risk to the volunteer's health).\n6. History of any significant acute or chronic illness that, in the investigator's opinion, could interfere with the trial or pose additional risk in administering the investigational drug. Examples include significant cardiovascular, hepatic, renal, gastrointestinal, hematologic, neurologic, psychiatric, or respiratory conditions that are not well-controlled.\n7. Recent major surgery (within 3 months prior to screening) or planned elective surgery during the study period. (Minor outpatient procedures are allowed at the investigator's discretion.)\n8. Difficulty with venous access or an inability to tolerate blood draws, such that required PK sampling would be compromised.\n9. History of drug or alcohol abuse: positive urine drug screen at screening for illicit substances, or a history of significant drug abuse in the past 5 years. Regular use of cannabis is also exclusionary unless stopped prior to study.\n10. Positive screening alcohol breath test, or history of excessive alcohol intake (more than \\~14 units per week; 1 unit = 360 mL beer, 150 mL wine, or 45 mL of 40% spirit) within 6 months. Any indication of alcoholism or inability to refrain from alcohol during study participation.\n11. Use of any prescription or over-the-counter medications, herbal remedies, or supplements within 14 days prior to first dose, except hormonal contraceptives or occasional acetaminophen. (Any necessary medications may be reviewed by the investigator for approval if unlikely to interfere with study outcomes).\n12. Participation in another clinical trial of an investigational drug or device within 4 weeks (or 5 half-lives of that investigational product, whichever is longer) prior to dosing.\n13. Donation of \\>400 mL of blood (or significant blood loss of similar volume) within 3 months prior to screening, or donation of \\>200 mL within 1 month prior. (This is to avoid anemia or confounding volume loss).\n14. Receipt of any blood products or immunoglobulin therapy within 90 days before dosing.\n15. Chronic use of immunosuppressive medications (systemic corticosteroids, immunomodulators) within 45 days before dosing (inhaled\u002Ftopical steroids for mild conditions may be permitted).\n16. Regular use of nicotine products (smoking more than 5 cigarettes per day or equivalent) within 3 months prior to screening, or inability to refrain from tobacco\u002Fnicotine during the study.\n17. Pregnant or breastfeeding women. (Female volunteers must have a negative pregnancy test and not be nursing.)\n18. Any other condition that, in the opinion of the investigator, makes the volunteer unsuitable for study participation (e.g. inability to comply with protocol, or any factor that would jeopardize the volunteer's safety or the validity of the data).","65 Years",{"count":102,"type":22},[232],"PHASE1","This Phase 1\u002F2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source.\n\nThe current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.",[28],[236,237,238],"Acute Respiratory Distress Syndrome (ARDS)","Single Ascending Dose","Monoclonal Antibody","2026-05-20",{"date":241,"type":38},"2026-05-22",{"date":243,"type":22},"2026-05",{"date":245,"type":22},"2026-11",{"name":247,"class":93},"HTIC, Inc",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":255,"maxAge":128,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100592211","effect-of-eit-guided-peep-in-ards-patients-100592211","NCT06990477","Effect of EIT-guided PEEP in ARDS Patients","Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age≥18 years\n2. Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \\[PaO2\\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)\n3. Diagnosis of ARDS less than 72 hours\n\nExclusion Criteria:\n\n1. Expected to be mechanically ventilated for less than 48 hours\n2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV\n3. Undrained pneumothorax or subcutaneous emphysema\n4. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)\n5. Severe neuromuscular disease\n6. Hemodynamic instability\n7. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome\n8. Severe other organs dysfunction with a low expected survival (7 days) or palliative care\n9. Solid organ or hematologic tumors with the expected survival time less than 30 days\n10. Participating in other clinical trials within 30 days\n11. Pregnancy\n12. Refusal to sign the informed consent","19 Years",{"count":257,"type":22},2400,[25],"Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.",[28],"2026-05-19",{"date":241,"type":38},{"date":264,"type":22},"2026-05-13",{"date":266,"type":22},"2029-02-20",{"name":268,"class":45},"Southeast University, China",3,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":4},"100637472","influence-of-lung-recruitment-potential-on-peep-titration-strategies-in-ards-patients-100637472","NCT07603310","Influence of Lung Recruitment Potential on PEEP Titration Strategies in ARDS Patients.","Influence of the Lung Recruitment Potential on the Response to Two PEEP Titration Strategies in Patients With Acute Respiratory Distress Syndrome (ARDS)","RECRUIT-PEEP","Inclusion Criteria:\n\n* Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: acute onset, bilateral opacities not fully explained by heart failure or fluid overload, and PaO2\u002FFiO2 \\\u003C= 200 mmHg with PEEP \\>= 5 cmH2O.\n* ARDS duration \\\u003C 36 hours since fully meeting Berlin consensus criteria.\n* Relative hemodynamic stability: absence of refractory shock, defined as norepinephrine dose \\\u003C= 0.5 mcg\u002Fkg\u002Fmin.\n\nExclusion Criteria:\n\n* Evidence of active pulmonary air leaks (bronchopleural fistula, pneumothorax, pneumomediastinum).\n* Severe uncorrected hemodynamic instability (norepinephrine \\> 0.5 mcg\u002Fkg\u002Fmin).\n* Contraindications for esophageal balloon placement (esophageal obstruction, known perforation, recent esophageal surgery, severe esophagitis).\n* Elevated intracranial pressure or conditions where hypercapnia-induced increases in intracranial pressure must be avoided (intracranial hemorrhage, cerebral contusion, cerebral edema, mass effect with midline shift on CT).\n* Known pregnancy.\n* Severe coagulopathy (platelet count \\\u003C 5,000\u002FuL or INR \\> 3).\n* Airway opening pressure higher than 15 cmH2O (AOP \\> 15 cmH2O).\n* History of severe neuromuscular disease or chronic respiratory disease.\n* Having received invasive mechanical ventilation for more than 96 hours.\n* Inability to obtain informed consent or refusal by the legal representative.\n* Contained laparotomy (open abdomen).",{"count":279,"type":22},52,[25],"Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and diffuse alveolar collapse, often requiring invasive mechanical ventilation. Non-individualized mechanical ventilation settings can cause ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP) prevents alveolar collapse, but its effect varies among individuals. The recruitment-to-inflation (R\u002FI) ratio evaluates bedside lung recruitment potential. This pilot study aims to compare two individualized PEEP titration strategies-one guided by the best static respiratory compliance and another guided by transpulmonary pressure via an esophageal balloon-and evaluate how baseline lung recruitment potential alters the early physiological responses to these interventions. Both strategies are preceded by an identical, standardized pressure-controlled initial lung recruitment maneuver to establish a baseline recruitment state.",[28],[284,285,286,287,288,289,290],"Acute Respiratory Distress Syndrome","Positive End-Expiratory Pressure","Respiratory Mechanics","Lung Volume Measurements","Esophageal Monitoring","Ventilator-Induced Lung Injury","Artificial Respiration","2026-05-18",{"date":241,"type":38},{"date":172,"type":22},{"date":295,"type":22},"2027-09-30",{"name":297,"class":45},"Hospital Dr. Franco Ravera Zunino",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":4},"100636598","phase-2-continuous-vs-bolus-neuromuscular-blockade-regimens-in-moderate-to-severe-hypoxemic-respiratory-failure-and-ards-cobra-100636598","NCT07567768","Continuous vs Bolus Neuromuscular Blockade Regimens in Moderate to Severe Hypoxemic Respiratory Failure and ARDS (COBRA)","The Effect of Continuous vs Bolus Neuromuscular Blockade Regimens for Patients With Moderate to Severe Hypoxemic Respiratory Failure and ARDS (COBRA): A Pilot Randomized Controlled Trial","COBRA","Inclusion Criteria:\n\nAge ≥18 years\n\n* Mechanically ventilated and on a controlled ventilation mode\n* Diagnosis of moderate to severe ARDS (PaO₂\u002FFiO₂ ≤150 mmHg on PEEP ≥5 cm H₂O)\n* Bilateral pulmonary infiltrates consistent with ARDS\n* Randomized within 24 hours of meeting ARDS criteria\n\nExclusion Criteria:\n\n* Pregnancy\n* Known allergy or contraindication to rocuronium\n* Neuromuscular disorders (e.g., myasthenia gravis, Guillain-Barré syndrome)\n* Brain death or decision for withdrawal of life-sustaining therapy\n* Enrollment in a conflicting interventional trial",{"count":307,"type":22},100,[309],"PHASE2","Current clinical guidelines, such as those from the Surviving Sepsis Campaign and ARDSNet, recommend short-term NMBA use for patients with moderate to severe ARDS who exhibit persistent ventilator dyssynchrony or high plateau pressures despite deep sedation . However, they do not provide clear recommendations regarding the mode of administration. As a result, clinicians are left to extrapolate from limited or indirect evidence, which may lead to practice variation, uncertainty, and suboptimal care.\n\nThis pilot randomized controlled trial is designed to directly address this critical gap by comparing intermittent bolus administration versus continuous infusion of NMBAs in a pragmatic, real-world ICU setting. The study will assess feasibility metrics necessary to plan a definitive trial and generate preliminary clinical data on safety and effectiveness. By clarifying the comparative benefits and risks of each approach, the results may influence practice guidelines, reduce variation in care, and improve patient outcomes and reduce practice variation.patient outcomes, optimize resource use, and inform future guidelines on the management of moderate to severe ARDS.",[28],[30,313,314],"Neuromuscular Blockade","mechanical ventilation","2026-05-11",{"date":114,"type":38},{"date":318,"type":22},"2027-01-01",{"date":320,"type":22},"2028-01-01",{"name":322,"class":45},"University of Calgary",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":154,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":335,"conditions":336,"keywords":340,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":269},"100556548","phase-3-recommend-platform-trial-100556548","NCT06526533","RECOMMEND Platform Trial","Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)","RECOMMEND","PLATFORM INCLUSION CRITERIA:\n\n* Patients receiving ECMO\n* Patients enrolled in the EXCEL Registry - NCT03793257\n\nPLATFORM EXCLUSION CRITERIA:\n\n* Treating clinician regards death as imminent and inevitable\n* Treating clinician determines it is not in the patient's best interests\n\nRBC TRANSFUSION DOMAIN INCLUSION CRITERIA:\n\n• Aged 18 years or older\n\nRBC TRANSFUSION DOMAIN EXCLUSION CRITERIA:\n\n* Contraindication to RBC transfusion (including known patient preference)\n* Limitations of care put in place either through patient wishes or the treating medical teams.\n* Participant has already received ECMO \\>12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start of ECMO is defined as the arrival time into the initial ICU (post-surgery)\n* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow\n* The treating physician deems the study is not in the patient's best interest\n* The treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds\n* Actively listed for a solid organ transplant and has not yet received one\n* Suspected or confirmed to be pregnant\n* Previous ECMO treatment during the same hospital admission",{"count":332,"type":22},600,[334],"PHASE3","The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO)\n\nThe main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO.\n\nResearchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort.\n\nParticipants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.",[337,28,338,339,62],"Extracorporeal Membrane Oxygenation Complication","Intensive Care Medicine","Cardiac Arrest (CA)",[341,342,343,344,345,346,347,348,349,350],"ECMO","ICU","Platform Trial","Australia","Cardiac","Respiratory","VA","VV","eCPR","Adaptive",{"date":264,"type":38},{"date":353,"type":38},"2026-03-23",{"date":355,"type":22},"2029-06",{"name":357,"class":45},"Australian and New Zealand Intensive Care Research Centre",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":46},"100637709","phase-2-ondansetron-for-the-prevention-of-patient-self-inflicted-lung-injury-in-patients-with-ards---pilot-rct-100637709","NCT07588217","Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT","A Pilot, Randomized, Controlled Clinical Trial Evaluating Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury Through Inhibition of Respiratory Drive in Patients With Acute Respiratory Distress Syndrome (OSIRIS-1)","OSIRIS-1","Inclusion Criteria:\n\n* Moderate-to-severe ARDS with all of the following:\n* Hypoxemic respiratory failure with PaO2:FiO2 \\\u003C 200 (on IMV with PEEP ≥ 5)\n* Precipitated within 1 week of an acute condition\n* Bilateral opacities on chest radiography and computed tomography or bilateral B lines and\u002For consolidations on ultrasound not fully explained by effusions, atelectasis, or nodules\u002Fmasses\n* Pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema\u002Ffluid overload\n* Hypoxemia\u002Fgas exchange abnormalities not primarily attributable to atelectasis\n* IMV initiated \\\u003C 96 hours\n* Extubation not anticipated within 24 hours\n\nExclusion Criteria:\n\n* Neuromuscular disease impairing spontaneous breathing\n* Pregnancy\n* Liver cirrhosis (Child B or C) or other severe impairment of hepatic function\n* Bradycardia (baseline pulse\\\u003C50\u002Fmin) on screening day\n* Known long QT syndrome\n* History of sustained ventricular tachycardia\n* Active digestive \u002F abdominal infection44\n* QTc prolongation \\> 470 msec in men and \\> 480 msec in women on screening day\n* On a medication at high risk of QT prolongation (Table 5)50\n* On two or more serotonergic medications (Table 6)51\n* Hypersensitivity \u002F intolerance to 5-HT3 antagonists\n* Patient deemed unlikely to survive past 24 hours or being transitioned to a fully palliative philosophy of care",{"count":367,"type":22},76,[309,334],"Acute Respiratory Distress Syndrome (ARDS) is a serious condition where the lungs become inflamed, leading to severe breathing difficulties. Despite advances in medical care, ARDS remains a life-threatening illness with a high risk of death and long-term complications. One way doctors help ARDS patients is by using special ventilation techniques to protect the lungs from further damage. However, this often requires heavy sedation or even paralyzing medications, which can lead to other problems like delirium, muscle weakness, and longer hospital stays. Allowing patients to breathe on their own might offer benefits, but it also comes with risks. Many ARDS patients have a very strong urge to breathe, which can cause them to overexert their lungs, potentially leading to additional lung damage, known as patient selfinflicted lung injury (P-SILI). Our early research suggests that a medication called ondansetron, commonly used to prevent nausea, might help reduce this strong breathing drive in ARDS patients, possibly preventing further lung injury. The OSIRIS research program is designed to explore whether ondansetron can protect ARDS patients from P-SILI, ultimately improving their chances of survival and reducing long-term complications. The first part of this program, OSIRIS-1, is a small pilot study where we will test the feasibility of running a larger, more definitive trial. We will randomly assign ARDS patients to receive either ondansetron or a placebo, given intravenously four times a day, and monitor their heart rhythms closely to ensure safety. We will also track how well patients stick to the study plan and whether ondansetron helps reduce their breathing drive and lung strain. If successful, this research could lead to new ways of treating ARDS that rely less on heavy sedation, potentially improving outcomes for these critically ill patients and setting the stage for larger, more comprehensive studies in the future.",[28,371,372],"Invasive Mechanical Ventilation","Patient-Self Inflicted Lung Injury",[374,375,376,377],"ondansetron","5HT3 antagonist","respiratory drive","respiratory effort","2026-05-08",{"date":114,"type":38},{"date":40,"type":22},{"date":382,"type":22},"2029-10-01",{"name":384,"class":45},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":210},"100570010","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-a-vilobelimab-100570010","NCT06701682","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab","Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization\n\nExclusion Criteria:\n\n* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.",{"count":393,"type":22},200,[309],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort A: Participants will be randomized to receive either a placebo or vilobelimab.\n\nThis record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[236,30,28,284],[398,399,30,284,400],"BARDA","JUST BREATHE","Acute Respiratory Failure","2026-05-07",{"date":378,"type":38},{"date":404,"type":38},"2025-06-21",{"date":406,"type":22},"2028-09",{"name":408,"class":93},"PPD Development, LP",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":390,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":210},"100570009","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-b-paridiprubart-100570009","NCT06701669","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:\n\n\\- ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n-Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80",{"count":393,"type":22},[309],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort B: Participants will be randomized to receive either a placebo or paridiprubart.\n\nThis record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[236,30,28,284],[398,399,30,284,400],{"date":378,"type":38},{"date":422,"type":38},"2025-06-10",{"date":406,"type":22},{"name":408,"class":93},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":390,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":439,"locationsCount":210},"100570117","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards-master-record-100570117","NCT06703073","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)","Inclusion Criteria:\n\n* Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements\n* Participant is at least 18 years of age or older at the time of consent.\n* Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.\n\nNote that participants on noninvasive ventilation may be screened.\n\n* Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply\n* Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).\n\nExclusion Criteria:\n\n* Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.\n* Participant with pulmonary edema due to cardiogenic pulmonary edema\u002Ffluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.\n* Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.\n* Participant is known to be pregnant, nursing, or with a positive (urine and\u002For serum test) pregnancy test.\n* Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.\n* Participant is not expected to survive for 72 hours.\n* Participant has been on invasive mechanical ventilation or ECMO for more than 48 hours for ARDS at the time of consent.\n* Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation\n* Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.\n* Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.\n* Participant has NY Heart Association Class IV congestive heart failure.\n* Participant has a known allergy to any study medication or any of its excipients.\n* Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication.\n\nNOTE: Patients on chronic low dose immunosuppressive therapy may be enrolled at the discretion of the investigator in consultation with the medical monitor.\n\n* Participant is undergoing active cancer systemic chemotherapy.\n* Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.\n* Participant with concurrent infections or history of the following:\n\n  1. Known active tuberculosis,\n  2. Known active Hepatitis B, or\n  3. HIV and a CD4 count less than 50 or a detectable viral load of \\>200 copies\u002FmL HIV RNA.\n* Participant received treatment with any other investigational drugs within 30 days prior to consent.\n* Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.\n* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n\nParticipant may have additional cohort-specific requirements.",{"count":332,"type":22},[309],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.\n\nThis record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.",[236,30,28,284],[398,399,30,284,400],{"date":378,"type":38},{"date":422,"type":38},{"date":406,"type":22},{"name":408,"class":93},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":390,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":210},"100570008","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-c-bevacizumab-100570008","NCT06701656","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of mild, moderate or severe, based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant has a known allergy or hypersensitivity to the active substance\u002Fexcipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies\n* Participant with established cirrhosis and Child-Pugh Score of 7 or greater\n* Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \\\u003C 2+\n* The hospitalized participant has a history or currently experiencing the following:\n\n  1. Participant must not have an international normalized ratio (INR) \\>1.5 and\u002For aPTT \\>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and\u002For activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.\n  2. Participant with recent serious hemorrhage or history of recent hemoptysis \\> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.\n  3. Participant with inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.\n  4. Participant with a history of hypertensive crisis or hypertensive encephalopathy.\n  5. Participant with a history of Grade ≥ 4 venous thromboembolisms.\n  6. Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.\n  7. Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.\n  8. Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.\n  9. Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).\n  10. Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.\n  11. Participant with a platelet count of \\\u003C75×109\u002FL.\n  12. Participant with current or recent (\\\u003C10 days prior to initiation of study treatment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n  13. Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.\n  14. Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.",{"count":393,"type":22},[309],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort C: Participants will be randomized to receive either a placebo or bevacizumab.\n\nThis record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[236,30,28,284],[398,399,30,284,400],{"date":378,"type":38},{"date":453,"type":38},"2025-10-28",{"date":406,"type":22},{"name":408,"class":93},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":472,"locationsCount":46},"100599398","prone-position-assessed-by-3d-eit-100599398","NCT07083973","Prone Position Assessed by 3D EIT","Prone Position Assessment by 3D EIT in ARDS Patients","Inclusion Criteria:\n\n* patients on mechanical ventilation.\n* Diagnosis of ARDS was based on the Berlin definition\n* Patients in need of prone position because of clinical condition\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Pregnant women;\n* Ribcage malformation\n* Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).",{"count":185,"type":22},"To investigate global and regional changes in lung ventilation and perfusion induced by prone position in ARDS patients assessed by 3D-EIT. And to investigate the difference between 2D-EIT and 3D-EIT in prone position monitoring.",[28,61],"2026-01-23",{"date":468,"type":38},"2026-01-26",{"date":470,"type":38},"2024-10-31",{"date":116,"type":22},{"name":71,"class":45},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":128,"enrollmentInfo":479,"targetDuration":480,"studyType":82,"phases":4,"briefSummary":481,"conditions":482,"keywords":491,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":4},"100619962","the-caribbean-registry-of-extracorporeal-membrane-oxygenation-ecmo-from-the-university-hospital-in-martinique-100619962","NCT07351435","The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique","Inclusion Criteria:\n\n* All consecutive patients implanted with a veno-venous extracorporeal membrane oxygenation device or extracorporeal membrane oxygenation device by the HeartTeam from the University Hospital of Martinique (UHM) from January 2010\n\nExclusion Criteria:\n\n* Patients with incomplete data (primary endpoint and less than 80% secondary study outcomes)",{"count":81,"type":22},"1 Year","The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.",[483,484,485,486,487,488,28,489,339,490,400],"Cardiogenic Shock","Malignant Arrhythmias","Ischemic or Valvular Heart Failure","Drepanocytosis and Thoracic Syndrome","Pulmonary Thromboembolisms","Sepsis","Intoxication","Postcardiotomy Heart Failure",[492,493],"acute heart failure","respiratory insufficiency","2026-01-09",{"date":496,"type":38},"2026-01-20",{"date":498,"type":22},"2026-02-01",{"date":500,"type":22},"2033-06-30",{"name":502,"class":45},"University of Genova",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":510,"targetDuration":511,"studyType":82,"phases":4,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":46},"100618103","cyclic-on-off-switching-of-pulmonary-blood-flow-in-moderate-to-severe-ards-100618103","NCT07327268","Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS","Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS Patients With Mechanical Ventilation","Inclusion Criteria:\n\n1. Adult patients with mechanical ventilation\n2. diagnosis of moderate to severe ARDS no more than 72 hours\n\nExclusion Criteria:\n\n1. Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease\n2. Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)\n3. Undrained pneumothorax or pneumomediastinum,\n4. Hemodynamic instability\n5. Pregnancy\n6. Refusal by family or the attending physician to participate in the study.",{"count":210,"type":22},"28 Days","Although the theoretical model of \"cyclic on-off switching of pulmonary blood flow\" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution. Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow. However, if 3D-EIT can help to identify \"cyclic on-off switching of pulmonary blood flow\" is still unclear.",[28,514,515],"Electrical Impedance Tomography (EIT)","Pulmonary Perfusion","2025-12-25",{"date":518,"type":38},"2026-01-08",{"date":520,"type":22},"2026-01-01",{"date":522,"type":22},"2026-08-31",{"name":268,"class":45},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":46},"100616759","lung-eit-image-guide-ventilation-in-ards-100616759","NCT07309783","Lung EIT Image Guide Ventilation in ARDS","Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL","Inclusion Criteria:\n\n* Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:\n\n  1. Triggered by acute risk factors such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not entirely or predominantly attributable to cardiogenic causes or fluid overload, and hypoxemia\u002Fgas exchange impairment is not mainly due to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if predisposing risk factors exist.\n  2. Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.\n  3. Bilateral opacities on chest radiograph or CT, or bilateral B-lines and\u002For consolidation on ultrasound, not fully explained by effusion, atelectasis, or nodules\u002Fmasses.\n  4. PaO₂\u002FFiO₂ ≤ 300 mm Hg or SpO₂\u002FFiO₂ ≤ 315 (if SpO₂ ≤ 97%).\n* ARDS onset within 1 week.\n* Mechanical ventilation ≤ 72 hours.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy.\n* Contraindications to EIT application (e.g., local skin lesions, cardiac pacemaker).\n* Contraindications to prone positioning (e.g., increased intracranial pressure, intra-abdominal hypertension, spinal fractures).\n* Evidence of barotrauma such as pneumothorax, mediastinal emphysema, or subcutaneous emphysema.\n* End-stage disease.\n* Informed consent not signed by legal guardians or family.",{"count":532,"type":22},574,[25],"The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS).\n\nThe main questions it aims to answer are:\n\nDoes the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes.\n\nAdult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization:\n\nEIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver).\n\nControl group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance.\n\nBoth groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points.\n\nPrimary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.",[28],[30,537,538,539,540],"EIT-guided ventilation strategy","EIT-guided prone positioning","EIT-guided PEEP setting","RCT","2025-12-16",{"date":67,"type":38},{"date":544,"type":22},"2025-12-20",{"date":546,"type":22},"2029-06-20",{"name":71,"class":45},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":46},"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":557,"type":22},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.",[560,488,28],"Acute Hypoxemic Respiratory Failure","2025-12-02",{"date":563,"type":38},"2025-12-15",{"date":565,"type":22},"2026-03-01",{"date":567,"type":22},"2027-11-01",{"name":569,"class":45},"Hospital Universitari Vall d'Hebron Research Institute",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100583445","free-for-weaning-ecmo-vs-respiratory-driven-study-100583445","NCT06876415","Free for Weaning ECMO vs Respiratory Driven Study","Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study","FORWARD","Inclusion Criteria:\n\n* Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study\n* Patient on veno-venous ECMO with weaning criteria, including:\n* Resolution of the cause of ARDS\n* Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg\u002Fkg\u002Fmin for at least 3 hours\n* Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)\n* Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml\u002Fkg of predicted body weight (PBW)\n* ECMO membrane sweep flow ≤ 2 L\u002Fmin\n* Patient protected by social security\n\nExclusion Criteria:\n\n* Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),\n* Patient with treatment limitation at the time of inclusion,\n* Patient in the time frame of exclusion from another research protocol at the time of consent signing,\n* Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.",{"count":579,"type":22},50,[25],"In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.\n\nSchematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).\n\nRecent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was \"forced,\" i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.\n\nTherefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.",[28],[584,585],"veno-venous ECMO","Decannulation","2025-11-18",{"date":588,"type":38},"2025-11-19",{"date":590,"type":38},"2025-07-29",{"date":592,"type":22},"2027-09",{"name":594,"class":45},"Assistance Publique Hopitaux De Marseille",4,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":201},"100607398","the-impact-of-low-versus-high-positive-end-expiratory-pressure-on-diaphragm-function-ventilation-efficiency-and-lung-mechanics-100607398","NCT07188038","The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics","The Impact of Low Versus High Positive End-Expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics During Pressure Support Ventilation: A Randomized Interventional Crossover Study","INFLATE-ICU","Inclusion Criteria:\n\n* Mechanical ventilation with pressure support or mechanical ventilation with possibility to transition to pressure support\n* Oxygen requirement ≤ 50%\n* Pressure support ≤ 12 cmH2O\n* PEEP ≤ 12 cmH2O\n* Age ≥ 18 years\n* Adequate intravascular volume status\n\nExclusion Criteria:\n\n* Circulatory instability\n* Brain death diagnosis\u002Fbrain death evaluation\n* Norepinephrine dose \\> 0.4 µg\u002Fkg\u002Fmin\n* Muscle relaxation administered within 2 hours\n* Pregnancy\n* Contraindication to esophageal catheterization (e.g., esophageal varices)\n* Conditions with increased risk of pneumothorax (such as severe COPD (Chronic Obstructive Pulmonary Disease) or extensive emphysema)\n* Untreated pneumothorax\n* Symptomatic airway obstruction\n\nDiscontinuation criteria during ongoing study intervention:\n\n* Heart rate \\> 120 beats\u002Fmin\n* Systolic blood pressure \\> 180 mmHg\n* Inspired oxygen fraction \\> 70%\n* Respiratory rate \\> 35\u002Fmin\n* RASS (Richmond Agitation Sedation Scale) ≥ 2\n* Doubling of norepinephrine dose or increase of norepinephrine dose to \\> 0.5 µg\u002Fkg\u002Fmin to maintain mean arterial pressure\n* Bradycardia \\\u003C 45 beats\u002Fmin",{"count":7,"type":22},[25],"The goal of this interventional study is to evaluate the effect of different positive end-expiratory pressures (PEEP) on lung and diaphragm function in patients mechanically ventilated with pressure support ventilation in the intensive care unit. The main questions aim to answer:\n\nDoes higher PEEP level affect diaphragm contractions and ventilatory efficiency? Does higher PEEP level limit inspiratory efforts? Does higher PEEP level affect lung compliance?\n\nThe participants will be subjected to three different PEEP levels during pressure support ventilation:\n\nLow PEEP (4 cmH2O), Medium PEEP (10 cmH2O), High PEEP (16 cmH2O).\n\nThe lung and diaphragm function will be evaluated using high-resolution esophageal manometry, electrical activity of the diaphragm, external diaphragm ultrasound and spirometric ventilator data.",[61,28,165,608],"Respiratory Insufficiency",[610,191,611,612,613,614,615,616],"Positive end-expiratory pressure","pressure support ventilation","assisted breathing","Inspiratory effort","Inspiratory drive","Ventilation efficiency","Diaphragm","2025-09-15",{"date":619,"type":38},"2025-09-23",{"date":621,"type":22},"2025-10-01",{"date":219,"type":22},{"name":624,"class":625},"Vastra Gotaland Region","OTHER_GOV","ARDS: Acute Respiratory Distress Syndrome"]