[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632667":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":18,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":18,"enrollmentInfo":42,"targetDuration":18,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":53,"whyStopped":18,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":18},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Expérimental : ECLS","EXPERIMENTAL","* ECLS catheter s inserted, and EC LS initiated no later than 12h after randomization\n* Vt decreased to a min of 3 ml\u002Fkg PBW (by 0.5ml\u002Fkg every 30 min) to reach ΔP 9-11 cm H2O and at least 5 cm H 2 O ΔP decrease\n* PEEP adjusted to keep the same mean airway pressure\n* Pump outflow set at 2-4 L\u002Fmin , based on the need of blood oxygenation\n* RR decreased to a min of 12\u002Fmin with gas flow rate adjusted to maintain PaCO2 45 mmHg.\n* Protocolized weaning of ECLS",[13],"Procedure: ECLS",{"label":15,"type":16,"description":17,"interventionNames":18},"Control : Conventional Treatment Arm","NO_INTERVENTION","* Conventional management of ARDS\n* Ventilatory settings:\n\n  * Volume assist control mode,\n  * VT 6 ml\u002Fkg of predicted body weight\n  * PEEP adjusted for Pplateau 28 29 cmH2O ;\n  * FiO2 for 88%≤SaO2≤95% or 55 mmHg≤PaO2≤80 mm Hg\n  * RR up to 35\u002Fmn, for a PaCO2 resulting in 7.30\\\u003CpH\\\u003C7.42",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","ECLS","* ECLS catheters inserted, and EC LS initiated no later than 12h after randomization\n* Vt decreased to a min of 3 ml\u002Fkg PBW (by 0.5ml\u002Fkg every 30 min) to reach ΔP 9 -11 cmH2O and at least 5 cm H2O ΔP decrease\n* PEEP adjusted to keep the same mean airway pressure\n* Pump outflow set at 2-4 L\u002Fmin , based on the need of blood oxygenation\n* RR decreased to a min of 12\u002Fmin with gas flowrate adjusted to maintain PaCO2 45 mmHg.\n* Protocolized weaning of ECLS",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Alain COMBES, Professor of medicine","CONTACT","+33142163818","alain.combes@aphp.fr",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100632667","ultraprotective-lung-ventilation-with-respiratory-extracorporeal-life-support-for-ards-100632667",false,"NCT07516665","Ultraprotective Lung Ventilation With Respiratory Extracorporeal Life Support for ARDS","NOVAEOLIA","Inclusion Criteria:\n\n1. Intubation and Invasive mechanical ventilation ≤ 7 days\n2. Presence of all of the following conditions for ≤48 hours:\n\n   * 80 ≤ PaO2\u002FFiO2 ≤300 with PEEP \\>5 cmH2O\n   * Bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   * Respiratory failure not fully explained by cardiac failure or fluid overload\n3. One of the following criteria (with Vt set at 6 mL\u002Fkg PBW):\n\n   * DeltaP ≥15 cm H2O OR\n   * Ventilatory ratio ≥2.2\n4. Signed Informed consent from a close relative or surrogate or a family member. According to the specifications of emergency inclusion, randomization without the close relative\u002Fsurrogate consent could be performed if the patient is unable to give his\u002Fger consent and when the close relative\u002Fsurrogate\u002Ffamily member are absent. Close relative\u002Fsurrogate\u002Ffamily member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his\u002Fher consent for the continuation of the trial when his\u002Fher condition will allow.\n5. Social security registration (AME excluded)\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Pregnancy or breastfeeding\n3. Catheter access to femoral vein or jugular vein impossible\n4. Expected duration of mechanical ventilation \\\u003C 48 hours\n5. Chronic restrictive or obstructive (COPD) respiratory insufficiency with home ventilation or oxygen therapy\n6. Currently receiving ECLS therapy\n7. Severe cardiac failure or ongoing acute coronary syndrome\n8. Heparin-induced thrombocytopenia\n9. Severe underlying pre-existing condition with expected six-month mortality \\>50%\n10. Contraindication for systemic anticoagulation (including platelet count \\\u003C50G\u002FL)\n11. Patient moribund, decision to limit therapeutic interventions\n12. Acute brain injury or irreversible neurological pathology\n13. Bone marrow transplantation within the last 1 year\n14. Actual body weight exceeding 1 kg per centimeter of height\n15. Prior enrolment in the trial","ALL","18 Years",{"count":43,"type":44},290,"ESTIMATED","INTERVENTIONAL",[47],"NA","Acute respiratory distress syndrome (ARDS) accounts for approximately 10% of all ICU admissions and 23% of patients requiring mechanical ventilation (MV). Despite advances in care, hospital mortality remains high, ranging from 34% in mild cases to 46% in severe ARDS. Positive-pressure MV remains the cornerstone of ARDS management. However, when excessive stress and strain are applied to the lung parenchyma, it can exacerbate lung injury, leading to ventilator-induced lung injury (VILI). VILI substantially contributes to morbidity and mortality in ARDS. Strategies that reduce tidal volume (Vt), driving pressure (ΔP, defined as plateau pressure minus PEEP), and respiratory rate (RR) can lower the mechanical power (PowerRS), i.e., the energy delivered to the lungs by the ventilator. This reduction in pulmonary stress and strain may lessen VILI and potentially improve survival. Nonetheless, reducing Vt to \\\u003C6 ml\u002Fkg in order to achieve plateau pressures \\\u003C23-25 cm H₂O, driving pressures \\\u003C9-11 cm H₂O, and RR \\\u003C15-20\u002Fmin can result in severe hypercapnia. This, in turn, may increase intracranial pressure, promote pulmonary hypertension, impair myocardial contractility, reduce renal perfusion, and trigger endogenous catecholamine release. Thus, such \"ultraprotective\" MV strategies are not feasible for most ARDS patients managed with conventional ventilation. The neutral findings of the REST trial further suggested that low-flow extracorporeal CO₂ removal (ECCO₂R) devices may provide insufficient CO₂ clearance to enable ultraprotective ventilation while adequately controlling respiratory acidosis. Moreover, since partial lung derecruitment may occur with substantial Vt reduction, extracorporeal membrane oxygenation (ECMO) may be necessary, particularly in patients with PaO₂\u002FFiO₂ \\\u003C120-130 at the time of Vt reduction. Therefore, respiratory extracorporeal life support (ECLS)-ranging from high-flow ECCO₂R to mid-flow venovenous ECMO (VV-ECMO)-can be employed in this setting. These modalities facilitate further reductions in ventilatory intensity while ensuring adequate oxygenation and CO₂ removal.",[50],"Acute Respiratory Distress Syndrome (ARDS)",[22,52],"Acute Respiratory Distress Syndorme (ARDS)","NOT_YET_RECRUITING","2026-04-09",{"date":56,"type":57},"2026-04-14","ACTUAL",{"date":59,"type":44},"2026-05-11",{"date":61,"type":44},"2028-08",{"name":5,"class":6}]