[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635969":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":67,"collaborators":54,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":54,"enrollmentInfo":80,"targetDuration":54,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":52,"whyStopped":54,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"King Faisal Specialist Hospital & Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","Standard of care method using tracheal mask (TM) for weaning tracheostomized mechanically ventilated patients",[13],"Device: Tracheal Mask (TM)",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention arm","EXPERIMENTAL","High-flow tracheal oxygen therapy (HFTO) for weaning tracheostomized mechanically ventilated patients",[19],"Device: High-flow tracheal oxygen (HFTO)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","High-flow tracheal oxygen (HFTO)","High-flow tracheal oxygen for weaning tracheosstomized mechanically ventilated patients",[15],[27],"HFTO",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Tracheal Mask (TM)","Standard of care using tracheal mask (TM) oxygen for weaning tracheostomized mechanically ventilated patients",[9],[33],"tracheal mask",[35],{"name":36,"affiliation":37,"role":38},"Zainab Al Duhailib, MBBS, MSc, EDIC","King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","00966112162919","42817","zainajd@gmail.com",{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},"Kafa Abuhdeeb","34423","kabuhdeeb@kfshrc.edu.sa",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"King Faisal Specialist Hospital and Research Centre","RECRUITING","Riyadh",null,"Saudi Arabia","SA",{"type":58,"coordinates":59},"Point",[60,61],46.72185,24.68773,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":54,"email":44},"Zainab Al Duhailib","00966568557353",{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Zainab Alduhailib","Consultant, Critical Care Medicine","100635969","high-flow-tracheal-oxygen-for-weaning-of-tracheostomized-patients-100635969",false,"NCT07559591","High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients","High Flow Tracheal Oxygen for Weaning of Tracheostomized Mechanically Ventilated Patients: A Pilot Randomised Controlled Trial (HFTO WEAN Trial)","HFTO-WEAN","Inclusion Criteria:\n\n1. Adults ≥ 18 years of age\n2. Intensive care unit (ICU) patients with tracheostomy inserted during the index ICU admission.\n3. Mechanically ventilated for ≤60 days.\n4. Successful spontaneous breathing trial for 1 hour.\n\nExclusion Criteria:\n\n1. Planned tracheostomy post head and neck surgery with ICU stay less than 48 hours\n2. Patient transferred from another hospital only if the intubation and tracheostomy dates are unavailable, otherwise would be eligible.\n3. Patient with an imminent plan for palliation and comfort care.\n4. Patient or substitute decision-maker declines consent to the study.\n5. The treating physician declines consent to the study.","ALL","18 Years",{"count":81,"type":82},88,"ESTIMATED","INTERVENTIONAL",[85],"NA","In this pilot randomized controlled trial (RCT), the investigators aim to explore the feasibility of conducting a powered RCT that examines the efficacy and safety of high flow tracheal oxygen (HFTO) in weaning critically ill tracheostomy patients from mechanical ventilation.\n\nObjective of the study\n\n1. To assess the feasibility of conducting a larger RCT as primary objective.\n2. To explore the effect of using HFTO in mechanically ventilated tracheostomized critically ill patients on ventilator-free days (VFD) compared to standard of care method using tracheal mask (TM) as secondary objective.",[88,89,90],"Tracheostomized Patients","Mechanical Ventilation Weaning","High Flow Oxygen Therapy",[92,93,94,95,96,97],"tracheostomized patients","tracheostomy","mechanical ventilation weaning","high flow tracheal oxygen","mechanical ventilation liberation","critically ill","2026-05-29",{"date":100,"type":101},"2026-06-02","ACTUAL",{"date":103,"type":101},"2026-05-17",{"date":105,"type":82},"2027-05",{"name":5,"class":6},1]