[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524148":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":195,"collaborators":26,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":26,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group : Imposed weaning protocol","EXPERIMENTAL","The flow of the HFNO will remain high (50-60 L\u002Fmin) guaranteeing the effectiveness of the HFNO on the wash-out of the anatomical space. At the same time, weaning will begin with a gradual reduction in FiO2 of 0.1 every 4 hours. To achieve this reduction, the patient will have to meet the safety targets of a stable respiratory rate at rest (no increase) and pulsed oxygen saturation (SpO2). The SpO2 target will be 92-95%. Once the FiO2 has stabilised at 0.4 for 4 hours, the nurse will initiate a 10 L\u002Fmin reduction in the flow of HFNO every 4 hours. The oxygen therapy support may be changed for standard oxygen when the HFNO flow rate is 40L\u002Fmin with an FIO2 of 0.4 for 4 consecutive hours.",[13],"Drug: HFNO weaning protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Weaning methods will be left to the free choice of the practitioner. Any change in the HFNO setting must be made on medical prescription. A minimum SpO2 objective is required (SpO2 ≥92%).",[19],"Drug: HFNO Standard of care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","HFNO weaning protocol","Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"HFNO Standard of care","Weaning methods will be left to the free choice of the practitioner.",[15],[32],{"name":33,"affiliation":34,"role":35},"Mai-Anh NAY, MD","CHRU Orléans","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","02.38.51.44.46","+33","mai-anh.nay@chr-orleans.fr",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Marie LECLERC","02.47.47.46.64","m.leclerc@chu-tours.fr",[47,64,77,90,105,118,131,144,157,169,182],{"facility":48,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Intensive care, University Hospital, Blois","RECRUITING","Blois","France","FR",{"type":54,"coordinates":55},"Point",[56,57],1.32912,47.59432,{"lat":57,"lon":56},[60,62],{"name":61,"role":38,"phone":26,"phoneExt":26,"email":26},"Julien GROUILLE, MD",{"name":63,"role":35,"phone":26,"phoneExt":26,"email":26},"Julien GROUILLE",{"facility":65,"status":49,"city":66,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Intensive care unit, University Hospital, Bourg-en-Bresse","Bourg-en-Bresse",{"type":54,"coordinates":68},[69,70],5.2258,46.20574,{"lat":70,"lon":69},[73,75],{"name":74,"role":38,"phone":26,"phoneExt":26,"email":26},"Salman Mohammad",{"name":76,"role":35,"phone":26,"phoneExt":26,"email":26},"Salman MOHAMMAD",{"facility":78,"status":49,"city":79,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Intensive care, University Hospital, Bourges","Bourges",{"type":54,"coordinates":81},[82,83],2.4,47.08333,{"lat":83,"lon":82},[86,88],{"name":87,"role":38,"phone":26,"phoneExt":26,"email":26},"Anna BOURREAU, MD",{"name":89,"role":35,"phone":26,"phoneExt":26,"email":26},"Anna BOURREAU",{"facility":91,"status":92,"city":93,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Intensive care unit, University Hospital, Caen","NOT_YET_RECRUITING","Caen",{"type":54,"coordinates":95},[96,97],-0.35912,49.18585,{"lat":97,"lon":96},[100,104],{"name":101,"role":38,"phone":102,"phoneExt":26,"email":103},"Pierrick BAUDUIN","0662885851","bauduin-p@chu-caen.fr",{"name":101,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":106,"status":49,"city":107,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Intensive care, University Hospital, Chartres","Chartres",{"type":54,"coordinates":109},[110,111],1.48925,48.44685,{"lat":111,"lon":110},[114,116],{"name":115,"role":38,"phone":26,"phoneExt":26,"email":26},"Juliette AUDIBERT, MD",{"name":117,"role":35,"phone":26,"phoneExt":26,"email":26},"Juliette AUDIBERT",{"facility":119,"status":49,"city":120,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Intensive care, University Hospital, Cholet","Cholet",{"type":54,"coordinates":122},[123,124],-0.87974,47.05893,{"lat":124,"lon":123},[127,129],{"name":128,"role":38,"phone":26,"phoneExt":26,"email":26},"Fabien JAROUSSEAU, MD",{"name":130,"role":35,"phone":26,"phoneExt":26,"email":26},"Fabien JAROUSSEAU",{"facility":132,"status":49,"city":133,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Intensive care, University Hospital, Dax","Dax",{"type":54,"coordinates":135},[136,137],-1.05366,43.71032,{"lat":137,"lon":136},[140,142],{"name":141,"role":38,"phone":26,"phoneExt":26,"email":26},"Adrien AUVET, MD",{"name":143,"role":35,"phone":26,"phoneExt":26,"email":26},"Adrien AUVET",{"facility":145,"status":49,"city":146,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Intensive care, University Hospital, Le Mans,","Le Mans",{"type":54,"coordinates":148},[149,150],0.20251,48.0021,{"lat":150,"lon":149},[153,155],{"name":154,"role":38,"phone":26,"phoneExt":26,"email":26},"Mickael LANDAIS, MD",{"name":156,"role":35,"phone":26,"phoneExt":26,"email":26},"Mickael LANDAIS",{"facility":158,"status":49,"city":159,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Intensive care, University Hospital, Orléans","Orléans",{"type":54,"coordinates":161},[162,163],1.90407,47.90248,{"lat":163,"lon":162},[166,167],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":168,"role":35,"phone":26,"phoneExt":26,"email":26},"Mai-Anh NAY",{"facility":170,"status":49,"city":171,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Intensive care, University Hospital, Tours","Tours",{"type":54,"coordinates":173},[174,175],0.70398,47.39484,{"lat":175,"lon":174},[178,180],{"name":179,"role":38,"phone":26,"phoneExt":26,"email":26},"Sophie JACQUIER, MD",{"name":181,"role":35,"phone":26,"phoneExt":26,"email":26},"Sophie JACQUIER",{"facility":183,"status":49,"city":184,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Intensive care unit, University Hospital, Vannes","Vannes",{"type":54,"coordinates":186},[187,188],-2.76205,47.65688,{"lat":188,"lon":187},[191,193],{"name":192,"role":38,"phone":26,"phoneExt":26,"email":26},"Agathe DELBOVE, MD",{"name":194,"role":35,"phone":26,"phoneExt":26,"email":26},"Agathe DELBOVE",{"type":196,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100524148","weaning-protocol-for-high-flow-nasal-oxygen-therapy-in-intensive-care-100524148",false,"NCT06104956","Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care","Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial","HiFloWEAN","Inclusion Criteria:\n\n* Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2\u002FFiO2 ratio \\\u003C300 mmHg)\n* Treated with HDNO for at least 24 hours in an intensive care unit or continuous care unit\n* Treated with HFNO with a flow rate ≥ 50L\u002Fmin and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion\n* With a ROX index (SpO2\u002FFiO2\u002FRespiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).\n* Had a blood gas test under HFNO within 24 hours of inclusion\n* Participant covered by or entitled to social security\n* Informed consent signed by the patient or its relatives if the patient is incapable; this consent must then be confirmed by the patient as soon as possible\n\nExclusion Criteria:\n\n* Presence of a patient included in the study and not weaned off HFNO in the sector managed by the nurse of the patient assessed for eligibility\n* Concomitant non-invasive ventilation treatment\n* Use of HFNO within 7 days of extubation\n* Chronic obstructive pulmonary disease (Gold grade 3 or 4)\n* Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure\n* Diffuse interstitial lung disease as a medical history\n* Patient with long-term non-invasive ventilation with external positive pressure\n* Patient on long-term oxygen therapy at home\n* Pregnant women, women in labour and breastfeeding mothers\n* Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.\n* Minor\n* Adult subject to a legal protection measure (guardianship, curators, person under court protection)\n* Patient with a medical decision not to intubate\n* Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays","ALL","18 Years","90 Years",{"count":209,"type":210},370,"ESTIMATED","INTERVENTIONAL",[213],"NA","High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.\n\nThe main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.\n\nThis is a open-label multicentre randomised controlled trial conducted in two parallel groups.\n\nThe primary endpoint is the success rate at Day 7, with success defined as \"definitive\" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.\n\nThe weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.",[216,217],"Acute Hypoxemic Respiratory Failure","High-flow Nasal Oxygen Therapy","2025-07-25",{"date":220,"type":221},"2025-07-30","ACTUAL",{"date":223,"type":221},"2024-02-17",{"date":225,"type":210},"2027-03",{"name":5,"class":6},11]