[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647839":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":24,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":24,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-flow oxygen","EXPERIMENTAL","Maximum tolerated flow (up to 50-60 L\u002Fmin), humidification chamber temperature set at 37 °C and FiO2 titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. Flow reduction will be allowed in case of intolerance and\u002For according to patients' requirements: flow ≥30 L\u002Fmin will be mandatory in all enrolled patients.\n\nWeaning from high-flow will not be considered before 24 hours from study enrolment and will be discouraged until the patient is considered for intensive care unit discharge.\n\nAfter weaning, patients will receive conventional oxygen.",[13],"Other: Oxygen therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional oxygen","ACTIVE_COMPARATOR","Patients will receive standard oxygen therapy via a heat and moisture exchanger (Tracheolife) or a Venturi tracheal mask device connected to a humidified source of oxygen. Oxygen flow or VenturiMask FiO2 will be titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. The use of tracheal high-flow will not be allowed under any circumstances in patients in this group.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Oxygen therapy","Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Domenico Luca Grieco","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Domenico Luca Grieco, MD","CONTACT","+393397681623","domenicoluca.grieco@unicatt.it",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Tommaso Rosà, MD","+393401427210","tommasoros22@gmail.com",[40],{"facility":41,"status":24,"city":42,"state":24,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"ICU, Fondazione Policlinico A. Gemelli IRCCS","Rome","00198","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],12.51133,41.89193,{"lat":50,"lon":49},{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100647839","trcheal-high-flow-for-weaning-from-mechanical-ventilation-100647839",false,"NCT07714564","Trcheal High-flow for Weaning From Mechanical Ventilation","Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial","TRACFLOW","Inclusion Criteria:\n\n* Tracheostomy\n* Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation\n* Hypoxemia (PaO2\u002FFiO2\\\u003C300) while on mechanical ventilation\n\nExclusion Criteria:\n\n* anticipated need for long-term mechanical ventilation\n* scheduled reconnections to mechanical ventilation\n* neuromuscular disease\n* chronic ventilator dependence\n* planned nocturnal home ventilation","ALL","18 Years",{"count":65,"type":66},500,"ESTIMATED","INTERVENTIONAL",[69],"NA","Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.",[72,73,74],"Tracheostomy","Mechanical Ventilation","Hypoxemic Respiratory Failure","NOT_YET_RECRUITING","2026-07-15",{"date":78,"type":79},"2026-07-20","ACTUAL",{"date":81,"type":66},"2026-10-01",{"date":83,"type":66},"2029-04-30",{"name":5,"class":6},1]