[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568995":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":215,"collaborators":18,"id":217,"slug":218,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":219,"sex":225,"minAge":226,"maxAge":18,"enrollmentInfo":227,"targetDuration":18,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":238,"overallStatus":244,"whyStopped":18,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Fondation Hôpital Saint-Joseph","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hypoxemic extubation group","EXPERIMENTAL","Randomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 \\\u003C 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the \"hypoxemic extubation group\" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours.",[13],"Other: early extubation of hypoxemic patients",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional extubation group","NO_INTERVENTION","Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%.\n\nAfter extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"early extubation of hypoxemic patients","patient extubated after the spontaneous ventilation trial despite the presence of hypoxemia defined by SpO2 ≤ 90% either in T-piece under 6 L\u002Fmin, or under FiO2 = 40% if SBT is performed in spontaneous ventilation with minimal inspiratory assistance.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Thibaut GENTY, M.D","CONTACT","0140942260","t.genty@gphsj.fr",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Francois GJ STEPHAN, M.D; Ph.D","0140948580","f.stephan@ghpsj.fr",[35,55,71,90,106,122,133,145,158,170,183,199],{"facility":36,"status":18,"city":37,"state":18,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"centre hospitalier Victor Dupouy","Argenteuil","95107","France","FR",{"type":42,"coordinates":43},"Point",[44,45],2.24744,48.94788,{"lat":45,"lon":44},[48,52],{"name":49,"role":27,"phone":50,"phoneExt":18,"email":51},"Gaetan Plantefeve, MD","0134231445","gaetan.plantefeve@ch-argenteuil.fr",{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"Gaetan Plantefeve","SUB_INVESTIGATOR",{"facility":56,"status":18,"city":57,"state":18,"zip":58,"country":39,"countryCode":40,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"CHRU de Besançon","Besançon","25030",{"type":42,"coordinates":60},[61,62],6.01815,47.24878,{"lat":62,"lon":61},[65,69],{"name":66,"role":27,"phone":67,"phoneExt":18,"email":68},"Sebastien Pili-Floury, MD, PhD","03 81 66 81 66","spilifloury@chu-besancon.fr",{"name":70,"role":54,"phone":18,"phoneExt":18,"email":18},"Sebastien Pili-Floury",{"facility":72,"status":18,"city":73,"state":18,"zip":74,"country":39,"countryCode":40,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Marie Lannelongue Hospital","Le Plessis-Robinson","92350",{"type":42,"coordinates":76},[77,78],2.27078,48.78889,{"lat":78,"lon":77},[81,84,87],{"name":82,"role":27,"phone":28,"phoneExt":18,"email":83},"Thibaut Genty, MD","t.genty@ghpsj.fr",{"name":85,"role":27,"phone":86,"phoneExt":18,"email":33},"francois stéphan, MD, PhD","0144128580",{"name":88,"role":89,"phone":18,"phoneExt":18,"email":18},"Thibaut Genty","PRINCIPAL_INVESTIGATOR",{"facility":91,"status":18,"city":92,"state":18,"zip":93,"country":39,"countryCode":40,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Hôpital Saint Eloi, CHU Montpellier","Montpellier","34090",{"type":42,"coordinates":95},[96,97],3.87635,43.61093,{"lat":97,"lon":96},[100,104],{"name":101,"role":27,"phone":102,"phoneExt":18,"email":103},"Samir Jaber, MD, PhD","04 67 33 72 71","s-jaber@chumontpellier.fr",{"name":105,"role":54,"phone":18,"phoneExt":18,"email":18},"Samir Jaber",{"facility":107,"status":18,"city":108,"state":18,"zip":109,"country":39,"countryCode":40,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"CHU la pitié salpêtrière","Paris","75013",{"type":42,"coordinates":111},[112,113],2.3488,48.85341,{"lat":113,"lon":112},[116,120],{"name":117,"role":27,"phone":118,"phoneExt":18,"email":119},"Jean Michel Constantin, MD, PhD","01.42.16.22.59","jean-michel.constantin@aphp.fr",{"name":121,"role":54,"phone":18,"phoneExt":18,"email":18},"Jean Michel Constantin",{"facility":107,"status":18,"city":108,"state":18,"zip":109,"country":39,"countryCode":40,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},{"type":42,"coordinates":124},[112,113],{"lat":113,"lon":112},[127,131],{"name":128,"role":27,"phone":129,"phoneExt":18,"email":130},"Adrien Bougle, MD, PhD","01 42 16 29 91","adrien.bougle@aphp.fr",{"name":132,"role":54,"phone":18,"phoneExt":18,"email":18},"Adrien Bougle",{"facility":134,"status":18,"city":108,"state":18,"zip":109,"country":39,"countryCode":40,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"CHU la pitié Salpêtrière",{"type":42,"coordinates":136},[112,113],{"lat":113,"lon":112},[139,143],{"name":140,"role":27,"phone":141,"phoneExt":18,"email":142},"Antoine Monsel, MD, PhD","01 42 17 58 89","antoine.monsel@aphp.fr",{"name":144,"role":54,"phone":18,"phoneExt":18,"email":18},"Antoine Monsel",{"facility":146,"status":18,"city":108,"state":18,"zip":147,"country":39,"countryCode":40,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Institut mutualiste Montsouris","75014",{"type":42,"coordinates":149},[112,113],{"lat":113,"lon":112},[152,156],{"name":153,"role":27,"phone":154,"phoneExt":18,"email":155},"Alexy Tran Dinh, MD","01 56 61 61 88","Alexy.tran-dinh@imm.fr",{"name":157,"role":54,"phone":18,"phoneExt":18,"email":18},"Alexy Tran Dinh",{"facility":159,"status":18,"city":108,"state":18,"zip":147,"country":39,"countryCode":40,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"réanimation polyvalente hopital saint joseph groupe hospitalier Paris saint Joseph",{"type":42,"coordinates":161},[112,113],{"lat":113,"lon":112},[164,168],{"name":165,"role":27,"phone":166,"phoneExt":18,"email":167},"Cédric Bruel, MD","0144127856","cbruel@ghpsj.fr",{"name":169,"role":54,"phone":18,"phoneExt":18,"email":18},"Cédric Bruel",{"facility":171,"status":18,"city":108,"state":18,"zip":172,"country":39,"countryCode":40,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"hôpital george Pompidou","75015",{"type":42,"coordinates":174},[112,113],{"lat":113,"lon":112},[177,181],{"name":178,"role":27,"phone":179,"phoneExt":18,"email":180},"Bernard Cholley, MD, PhD","0156092515","bernard.cholley@aphp.fr",{"name":182,"role":54,"phone":18,"phoneExt":18,"email":18},"Bernard Cholley",{"facility":184,"status":18,"city":185,"state":18,"zip":186,"country":39,"countryCode":40,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"CHU de Reims","Reims","51092",{"type":42,"coordinates":188},[189,190],4.02853,49.26526,{"lat":190,"lon":189},[193,197],{"name":194,"role":27,"phone":195,"phoneExt":18,"email":196},"Salvatore Muccio, MD","03 10 73 66 50","smuccio@chu-reims.fr",{"name":198,"role":54,"phone":18,"phoneExt":18,"email":18},"Salvatore Muccio",{"facility":200,"status":18,"city":201,"state":18,"zip":202,"country":39,"countryCode":40,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Centre Cardiologique Du Nord","Saint-Denis","93200",{"type":42,"coordinates":204},[205,206],2.35387,48.93564,{"lat":206,"lon":205},[209,213],{"name":210,"role":27,"phone":211,"phoneExt":18,"email":212},"Jean Michel Maillet, MD","0149334141","jm.mailletmascarel@gmail.com",{"name":214,"role":54,"phone":18,"phoneExt":18,"email":18},"Jean Michel Maillet",{"type":216,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100568995","postoperative-extubation-in-hypoxemic-patients-100568995",false,"NCT06688487","Postoperative Extubation in Hypoxemic Patients","Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial","EPHYRE","Inclusion Criteria:\n\n* Francophone patient affiliated to a health insurance plan;\n* Patient having granted free, informed and written consent to participate in the study;\n* Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L\u002Fmin or FiO2 40% during spontaneous breathing trial.\n\nExclusion Criteria:\n\n* Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);\n* Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L\u002Fmin or FiO2 = 50%;\n* Presence of poor clinical tolerance of SBT defined by polypnoea above 30\u002Fmin, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;\n* Presence of an ineffective cough or major bronchial congestion;\n* Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and\u002For ventilatory support after extubation;\n* Anatomical factors precluding the use of NIV or high-flow oxygen therapy, notably facial or cervico-facial malformations;\n* Tracheostomized patient;\n* History of obstructive ventilatory disorders with indication for NIV post-extubation, chronic obstructive pulmonary disease (COPD) GOLD score III\u002FIV;\n* History of obstructive sleep apnea syndrome with equipment;\n* cardiogenic pulmonary edema;\n* Patient on extracorporeal membrane oxygenation (ECMO) at the time of inclusion;\n* Patient under guardianship or curatorship;\n* Minor patients;\n* Patient deprived of liberty or under court protection;\n* Pregnant or breast-feeding women;\n* Patient in therapeutic limitation with decision not to re-intubate.","ALL","18 Years",{"count":228,"type":229},152,"ESTIMATED","INTERVENTIONAL",[232],"NA","The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:\n\nDoes early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).",[235,236,237],"Hypoxemia","Extubation","Postoperative Respiratory Complication",[239,240,241,242,243],"extubation","hypoxemia","postoperative respiratory complication","weaning","facilitative non invasive strategy","NOT_YET_RECRUITING","2024-11-12",{"date":247,"type":248},"2024-11-14","ACTUAL",{"date":250,"type":229},"2024-11-18",{"date":252,"type":229},"2027-01-31",{"name":5,"class":6},12]