[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578672":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":181,"collaborators":26,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":26,"enrollmentInfo":193,"targetDuration":26,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group : near apneic ventilation","EXPERIMENTAL","Patients will received near apneic ventilation during the first 3 days of ECMO.",[13],"Device: ECMO + near apneic ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care : ultra-protective lung ventilation","ACTIVE_COMPARATOR","Patients will receive ultra-protective lung ventilation as it uses on usual care on ECMO.",[19],"Device: ECMO + ultra-protective lung ventilation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ECMO + near apneic ventilation","Near apneic ventilation will be use during the first 3 days of ECMO. Patients will be ventilated in BIPAP\u002FAPRV or pressure-controlled ventilation. PEEP will be set to maintain the same mean airway pressure obtained during the standardized ventilation period pre-randomization to prevent lung derecruitment (PEEP ≥15cmH2O). If BIPAP\u002FAPRV is used, an RR of 2-4\u002Fmin will be set with high pressure set at 30cmH20 for 3 sec. If pressure-controlled ventilation is selected, a respiratory rate of two sigh breaths\u002Fmin with 30 cmH2O plateau pressure will be applied. Each sigh breath will be of three seconds duration.\n\nNeuromuscular blockade and sedation could be used at the discretion of the attending physician. After 3 days on ECMO, apneic ventilation could be pursued (at the physician's discretion). If not, ultra-protective lung ventilation will be applied (i.e standard of care). Prone positioning on ECMO will be left to the physicians' discretion.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ECMO + ultra-protective lung ventilation","Ultra-protective lung ventilation will be used up to the ECMO weaning. This group will receive ultra-protective lung ventilation with BIPAP\u002FAPRV or VCV mode setting a PEEP \\>10 cmH2O, ΔP 14-15 cmH2O, RR 15-20\u002Fmin, Vt 3-4ml\u002Fkg and lowest FiO2 to maintain SpO2\\>92%.\n\nThe use of prone positioning during ECMO will be left at the physician's discretion.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Matthieu SCHMIDT, MD","CONTACT","01 42 16 29 37","matthieu.schmidt@aphp.fr",[38,55,67,80,93,106,118,131,144,155,168],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Avicenne Hospital","RECRUITING","Bobigny","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.45012,48.90982,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":54},"Johanna OZIEL","01 48 95 52 41","johanna.oziel@aphp.fr",{"facility":56,"status":40,"city":57,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Haut Levèque Hospital - CHU Bordeaux","Bordeaux",{"type":45,"coordinates":59},[60,61],-0.58046,44.84124,{"lat":61,"lon":60},[64],{"name":65,"role":34,"phone":26,"phoneExt":26,"email":66},"Benjamin REPUSSEAU","Benjamin.Repusseau@chu-bordeaux.fr",{"facility":68,"status":40,"city":69,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Henri Mondor Hospital","Créteil",{"type":45,"coordinates":71},[72,73],2.46569,48.79266,{"lat":73,"lon":72},[76],{"name":77,"role":34,"phone":78,"phoneExt":26,"email":79},"Armand MEKONTSO-DESSAP","01 45 17 85 11","armand.dessap@aphp.fr",{"facility":81,"status":40,"city":82,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Croix-Rousse Hospital - HCL","Lyon",{"type":45,"coordinates":84},[85,86],4.84789,45.74906,{"lat":86,"lon":85},[89],{"name":90,"role":34,"phone":91,"phoneExt":26,"email":92},"Jean-Christophe RICHARD","+33 4 72 04 17 62","j-christophe.richard@chu-lyon.fr",{"facility":94,"status":40,"city":95,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"North Hospital - APHM","Marseille",{"type":45,"coordinates":97},[98,99],5.38107,43.29695,{"lat":99,"lon":98},[102],{"name":103,"role":34,"phone":104,"phoneExt":26,"email":105},"Christophe GUERVILLY","+33 4 91 96 58 42","christophe.guervilly@ap-hm.fr",{"facility":107,"status":40,"city":108,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Mercy Hospital - CHR Metz","Metz",{"type":45,"coordinates":110},[111,112],6.17269,49.11911,{"lat":112,"lon":111},[115],{"name":116,"role":34,"phone":26,"phoneExt":26,"email":117},"Benjamin PEQUIGNOT","benjamin.pequignot@chr-metz-thionville.fr",{"facility":119,"status":40,"city":120,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Brabois Hospital - CHRU Nancy","Nancy",{"type":45,"coordinates":122},[123,124],6.18496,48.68439,{"lat":124,"lon":123},[127],{"name":128,"role":34,"phone":129,"phoneExt":26,"email":130},"Matthieu KOSZUSTKI","+33 3 83 15 30 17","m.koszutski@chru-nancy.fr",{"facility":132,"status":40,"city":133,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"CHU Orléans","Orléans",{"type":45,"coordinates":135},[136,137],1.90407,47.90248,{"lat":137,"lon":136},[140],{"name":141,"role":34,"phone":142,"phoneExt":26,"email":143},"François BARBIER","+33 2 38 22 99 39","francois.barbier@chu-orleans.fr",{"facility":145,"status":40,"city":146,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Pitié-Salpêtrière Hospital","Paris",{"type":45,"coordinates":148},[149,150],2.3488,48.85341,{"lat":150,"lon":149},[153],{"name":154,"role":34,"phone":35,"phoneExt":26,"email":36},"Matthieu SCHMIDT",{"facility":156,"status":40,"city":157,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Pontchaillou Hospital - CHU Rennes","Rennes",{"type":45,"coordinates":159},[160,161],-1.67431,48.11109,{"lat":161,"lon":160},[164],{"name":165,"role":34,"phone":166,"phoneExt":26,"email":167},"Arnaud GACOUIN","+33 2 99 28 97 31","arnaud.gacouin@chu-rennes.fr",{"facility":169,"status":40,"city":170,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"CHU Tours","Tours",{"type":45,"coordinates":172},[173,174],0.70398,47.39484,{"lat":174,"lon":173},[177],{"name":178,"role":34,"phone":179,"phoneExt":26,"email":180},"Emmanuelle MERCIER","+33 2 47 47 38 55","emmanuelle.mercier@univ-tours.fr",{"type":182,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100578672","phase-3-continuous-positive-airway-pressure-on-venovenous-extracorporeal-membrane-oxygenation-for-acute-respiratory-distress-syndrome-100578672",false,"NCT06814340","\"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme\"","\"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme\" - CALMDOWN","CALMDOWN","Inclusion Criteria:\n\n1. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.\n2. Obtain informed consent from a close relative or surrogate. 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\u002Fher 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.\n3. French Social security registration (except AME)\n\nExclusion Criteria:\n\n1. Age \\\u003C 18\n2. Pregnancy or breastfeeding\n3. Initiation of VV-ECMO \\> 48 h (maximum tolerance : +2h)\n4. Cardiac arrest with cumulated no flow time \\>10 minutes before ECMO (within 48 hours prior to inclusion)\n5. Irreversible neurological pathology\n6. End-stage chronic lung disease\n7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma\n8. Irreversible ARDS with no hope for lung function recovery\n9. Patient moribund on the day of randomization, SAPS II \\>90\n10. Liver cirrhosis (Child B or C)\n11. Lung transplantation\n12. Burns on more than 20 % of the body surface\n13. Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study\n14. Individuals under guardianship, or permanently legally incompetent adults","ALL","18 Years",{"count":194,"type":195},280,"ESTIMATED","INTERVENTIONAL",[198],"PHASE3","The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation).\n\nThe study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.\n\nIndeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.",[201,202],"Acute Respiratory Distress Syndrome","Extracorporeal Membrane Oxygenation Complication",[204,205,206],"ECMO","ARDS","CPAP","2026-04-08",{"date":209,"type":210},"2026-04-13","ACTUAL",{"date":212,"type":210},"2025-05-06",{"date":214,"type":195},"2030-05-06",{"name":5,"class":6},11]