[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643156":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":24,"enrollmentInfo":103,"targetDuration":24,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":118,"whyStopped":24,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm HHFO in first","EXPERIMENTAL","HHFO in first: in this arm, the first of the two consecutive apnea tests is performed under HHFO, followed by a second apnea test under CPAP.",[13,14],"Other: Apnea test under HHFO followed by an apnea test under CPAP.","Other: Apnea test under CPAP followed by an apnea test under HHFO.",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm CPAP in first.","CPAP in first: in this arm, the first of the two consecutive apnea tests is performed under CPAP, followed by a second apnea test under HHFO.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Apnea test under HHFO followed by an apnea test under CPAP.","For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.",[16,9],null,{"type":6,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Apnea test under CPAP followed by an apnea test under HHFO.",[16,9],[29,47,61,74],{"facility":30,"status":24,"city":31,"state":24,"zip":24,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Chu Angers","Angers","France","FR",{"type":35,"coordinates":36},"Point",[37,38],-0.55202,47.47156,{"lat":38,"lon":37},[41,45],{"name":42,"role":43,"phone":24,"phoneExt":24,"email":44},"Aurore ARMAND, MD","CONTACT","auarmand@chu-angers.fr",{"name":42,"role":46,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":48,"status":24,"city":49,"state":24,"zip":24,"country":32,"countryCode":33,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Chu de Nantes","Nantes",{"type":35,"coordinates":51},[52,53],-1.55336,47.21725,{"lat":53,"lon":52},[56,59],{"name":57,"role":43,"phone":24,"phoneExt":24,"email":58},"jaen-Baptiste LASCARROU, MD","jeanbaptiste.lascarrou@chu-nantes.fr",{"name":60,"role":46,"phone":24,"phoneExt":24,"email":24},"Jean-Baptiste LASCARROU, MD",{"facility":62,"status":24,"city":63,"state":24,"zip":24,"country":32,"countryCode":33,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Chu Orleans","Orléans",{"type":35,"coordinates":65},[66,67],1.90407,47.90248,{"lat":67,"lon":66},[70,73],{"name":71,"role":43,"phone":24,"phoneExt":24,"email":72},"Damien BARRIER","damien.barrier@chu-orleans.fr",{"name":71,"role":46,"phone":24,"phoneExt":24,"email":24},{"facility":75,"status":24,"city":76,"state":24,"zip":24,"country":32,"countryCode":33,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Chru de Tours","Tours",{"type":35,"coordinates":78},[79,80],0.70398,47.39484,{"lat":80,"lon":79},[83,86],{"name":84,"role":43,"phone":24,"phoneExt":24,"email":85},"Sophie JACQUIER, MD","s.jacquier@chu-tours.fr",{"name":84,"role":46,"phone":24,"phoneExt":24,"email":24},{"type":88,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[90],{"name":91,"class":92},"Fisher and Paykel Healthcare","INDUSTRY","100643156","efficacy-of-high-flow-humidified-oxygen-hfho-in-apneic-oxygenation-for-apnea-testing-a-comparison-with-continuous-positive-airway-pressure-cpap-100643156",false,"NCT07640009","Efficacy of High-Flow Humidified Oxygen (HFHO) in Apneic Oxygenation for Apnea Testing: A Comparison With Continuous Positive Airway Pressure (CPAP)","Efficacy of High-Flow Humidified Oxygen in Apneic Oxygenation During Apnea Testing Compared With Continuous Positive Airway Pressure: A Randomized Multicenter Crossover Trial","APNEAFLO2W","Inclusion Criteria:\n\n* Adult intensive care unit patients\n* fulfilling all criteria for clinical brain death, for whom confirmation of the absence of spontaneous breathing requires performance of an apnea test\n* And for whom consent to participate in the study was sought from a trusted person or a family member\n\nExclusion Criteria:\n\n* History of chronic obstructive pulmonary disease (COPD) classified as GOLD stage III or IV.\n* Current extracorporeal life support, including veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO).\n* PaO₂\u002FFiO₂ ratio ≤ 150 on the most recent arterial blood gas analysis, obtained within 24 hours prior to the screening visit.\n* Presence of at least one clear or absolute contraindication to the procurement of at least one organ.\n* Presence of a high cervical spinal cord injury.\n* Patient in the prone position and\u002For with a contraindication to placement in the supine position at 30°.\n* Minor patient.\n* Protected adult under legal guardianship or curatorship.\n* Individual under judicial protection (safeguard of justice).\n* Individuals deprived of liberty.\n* Individual not covered by a social security or health insurance system.\n* Pregnant or breastfeeding woman.","ALL","18 Years",{"count":104,"type":105},28,"ESTIMATED","INTERVENTIONAL",[108],"NA","Brain death (BD) is characterized by a severe brain injury resulting in irreversible loss of all brain and brainstem functions, while other organs may remain viable. The diagnosis of BD is based on the presence of coma, absence of brainstem reflexes, and absence of spontaneous breathing confirmed by an apnea test. In France, the apnea test is mandatory prior to organ procurement. The apnea test aims to demonstrate that hypercapnia, a strong ventilatory stimulus, does not induce any respiratory movements.\n\nIn current practice, the apnea test is performed by disconnecting the patient from mechanical ventilation for 8-10 minutes while administering oxygen. Oxygenation strategies during apnea vary across French centers. Although the use of continuous positive airway pressure (CPAP) is recommended, a substantial proportion of tests are still performed without positive end-expiratory pressure (PEEP) effect, using either an open T-piece or an intratracheal oxygen catheter. These methods are associated with a higher risk of complications, such as hypoxemia, and potential adverse effects on organ function, which is particularly relevant in the context of organ donation.\n\nHumidified high-flow oxygen (HHFO), delivered via a specialized device connected to the endotracheal tube, provides high flow rates (up to 60 L\u002Fmin), allows precise adjustment of the fraction of inspired oxygen (FiO₂ up to 1.0), and generates a minimal PEEP effect. HHFO is routinely used in intensive care units. While its feasibility during apnea testing has been reported, its efficacy during BD diagnosis has not been well evaluated.\n\nPreliminary observations in intensive care patients with clinical brain death suggest that HHFO can be safely used during the apnea test, allowing achievement of hypercapnia and confirmation of absence of spontaneous respiration while maintaining better oxygenation compared with conventional oxygen delivery via an open T-piece.\n\nThis study aims to evaluate the efficacy of HHFO for apneic oxygenation during the apnea test, in comparison with the recommended method using CPAP.",[111],"Death, Brain",[113,114,115,116,117],"Intensive Care Unit","Humidified high-flow oxygen therapy","Continuous positive airway pressure","Apnea testing","Brain death","NOT_YET_RECRUITING","2026-06-05",{"date":121,"type":122},"2026-06-10","ACTUAL",{"date":124,"type":105},"2026-09-15",{"date":126,"type":105},"2028-09-15",{"name":5,"class":6},4]