[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416826":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":219,"collaborators":12,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":223,"sex":229,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":12,"studyType":235,"phases":236,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","Patients will be intubated according to both the standard of care",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of care + ROX algorithm","EXPERIMENTAL","In the intervention arm, patients will be intubated according to both the standard of care and the ROX index, whichever are met first. If the patient has a ROX index below different thresholds after different time-point within the first 12 hours since randomization, the NHF support will be increased to the maximum tolerated flow (up to 60L\u002Fmin) and FIO2 of 1 and subsequently titrated with the target SpO2. Then, the ROX index will be recalculated in 30 minutes. If the patient is already treated with to 60L\u002Fmin) and FIO2 of 1 and no further increase could be done, the ROX index will be recalculated after 30 minutes of full NHF support. Then: 1) if the ΔROX is \\\u003C0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 30 minutes; and 3) if the ΔROX is \\>0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.",[18],"Diagnostic Test: ROX index algorithm",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","ROX index algorithm","The thresholds of the ROX index for intubation are the following:\n\n* After 2 hours of HFNC: ROX \\\u003C2.85.\n* After 4 and 6 hours of HFNC: ROX \\\u003C3.47\n* After 8, 10 and 12 hours of HFNC: ROX \\\u003C3.85 If the ROX index is between the abovementioned thresholds and 4.88, the NHF support will be also increased to the maximum tolerated flow (up to 60L\u002Fmin) and FIO2 of 1 and subsequently titrated with the target SpO2. If the patient is already treated with to 60L\u002Fmin) and FIO2 of 1 and no further increase could be done and the ROX index will be recalculated after 30 minutes of full NHF support. The ROX index will be recalculated in 30 minutes: 1) if the ΔROX is \\\u003C0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 20 minutes; and 3) if the ΔROX is \\>0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.",[14],[26],{"name":27,"affiliation":28,"role":29},"Oriol Roca, MD PhD","Universitat Autònoma de Barcelona (UAB)","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","+34932746209","oroca@tauli.cat",[36,55,73,89,101,123,135,149,162,175,190,206],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Rush University Chicago Hospital","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-87.65005,41.85003,{"lat":48,"lon":47},[51,54],{"name":52,"role":32,"phone":12,"phoneExt":12,"email":53},"Jie Li, MD PhD","jie_li@rush.edu",{"name":52,"role":29,"phone":12,"phoneExt":12,"email":12},{"facility":56,"status":57,"city":58,"state":12,"zip":12,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"First Affiliated Hospital of Chongqing Medical University","NOT_YET_RECRUITING","Chongqing","China","CN",{"type":45,"coordinates":62},[63,64],106.55771,29.56026,{"lat":64,"lon":63},[67,71],{"name":68,"role":32,"phone":69,"phoneExt":12,"email":70},"Jun Duan","MD","1062914316@qq.com",{"name":72,"role":29,"phone":12,"phoneExt":12,"email":12},"Jun Duan, MD",{"facility":74,"status":38,"city":75,"state":12,"zip":12,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"The Second Military Medical University Hospital","Shanghai",{"type":45,"coordinates":77},[78,79],121.45806,31.22222,{"lat":79,"lon":78},[82,85,86],{"name":83,"role":32,"phone":12,"phoneExt":12,"email":84},"Wei Zhang, MD PhD","zhangweismmu@126.com",{"name":83,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":87,"role":88,"phone":12,"phoneExt":12,"email":12},"Jun Wang, MD","SUB_INVESTIGATOR",{"facility":90,"status":57,"city":75,"state":12,"zip":12,"country":59,"countryCode":60,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Zhongshan Hospital, Fudan University",{"type":45,"coordinates":92},[78,79],{"lat":79,"lon":78},[95,98,99],{"name":96,"role":32,"phone":12,"phoneExt":12,"email":97},"Ming Zhong, MD","zhong.ming@zs-hospital.sh.cn",{"name":96,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":100,"role":88,"phone":12,"phoneExt":12,"email":12},"Huan Wang, MD",{"facility":102,"status":38,"city":103,"state":12,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":45,"coordinates":108},[109,110],2.15899,41.38879,{"lat":110,"lon":109},[113,116,118,119,121],{"name":114,"role":32,"phone":12,"phoneExt":12,"email":115},"Andrés Pacheco Reyes, MD","andres_pacheco19@hotmail.com",{"name":12,"role":32,"phone":12,"phoneExt":12,"email":117},"andresfrancisco.pacheco@vallhebron.cat",{"name":114,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":120,"role":88,"phone":12,"phoneExt":12,"email":12},"Francisco Ramos, MD",{"name":122,"role":88,"phone":12,"phoneExt":12,"email":12},"Mauro Acuña, MD",{"facility":124,"status":38,"city":103,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Hospital del Mar",{"type":45,"coordinates":126},[109,110],{"lat":110,"lon":109},[129,132,134],{"name":130,"role":32,"phone":12,"phoneExt":12,"email":131},"Irene Dot, MD","idot@psmar.cat",{"name":133,"role":29,"phone":12,"phoneExt":12,"email":12},"Joan R Masclans, MD PhD",{"name":130,"role":88,"phone":12,"phoneExt":12,"email":12},{"facility":136,"status":38,"city":137,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Hospital de Ciudad Real","Ciudad Real",{"type":45,"coordinates":139},[140,141],-3.92907,38.98626,{"lat":141,"lon":140},[144,147],{"name":145,"role":32,"phone":12,"phoneExt":12,"email":146},"Ramón Ortiz","ramonortiz1980@hotmail.com",{"name":148,"role":29,"phone":12,"phoneExt":12,"email":12},"Ramón Ortiz, MD",{"facility":150,"status":38,"city":151,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital Civil Fray Antonio Alcalde","Guadalajara",{"type":45,"coordinates":153},[154,155],-3.16185,40.62862,{"lat":155,"lon":154},[158,161],{"name":159,"role":32,"phone":12,"phoneExt":12,"email":160},"Miguel Ibarra, MD","drmiguelibarra@hotmail.com",{"name":159,"role":29,"phone":12,"phoneExt":12,"email":12},{"facility":163,"status":38,"city":164,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Hospital Son Llàtzer","Palma de Mallorca",{"type":45,"coordinates":166},[167,168],2.65024,39.56939,{"lat":168,"lon":167},[171,174],{"name":172,"role":32,"phone":12,"phoneExt":12,"email":173},"Gemma Rialp, MD PhD","grialp@gmail.com",{"name":172,"role":29,"phone":12,"phoneExt":12,"email":12},{"facility":176,"status":38,"city":177,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Hospital Parc Taulí","Sabadell",{"type":45,"coordinates":179},[180,181],2.10942,41.54329,{"lat":181,"lon":180},[184,185,186,188],{"name":27,"role":32,"phone":12,"phoneExt":12,"email":34},{"name":27,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":187,"role":88,"phone":12,"phoneExt":12,"email":12},"Marina García, MD",{"name":189,"role":88,"phone":12,"phoneExt":12,"email":12},"Mireia Cerdà, MD",{"facility":191,"status":38,"city":192,"state":12,"zip":193,"country":105,"countryCode":106,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Hospital Moisès Broggi","Sant Joan Despí","08970",{"type":45,"coordinates":195},[196,197],2.0574,41.36718,{"lat":197,"lon":196},[200,203,204],{"name":201,"role":32,"phone":12,"phoneExt":12,"email":202},"Melinda Popoviciu, MD","melindarita.popoviciukoborzan@sanitatintegral.org",{"name":201,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":205,"role":88,"phone":12,"phoneExt":12,"email":12},"Edgar Cortés, MD",{"facility":207,"status":38,"city":208,"state":12,"zip":12,"country":105,"countryCode":106,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Hospital Virgen de la Salud","Toledo",{"type":45,"coordinates":210},[211,212],-4.02263,39.8581,{"lat":212,"lon":211},[215,218],{"name":216,"role":32,"phone":12,"phoneExt":12,"email":217},"Gonzalo Hernández, MD PhD","ghernandezm@telefonica.net",{"name":216,"role":29,"phone":12,"phoneExt":12,"email":12},{"type":220,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100416826","rox-index-for-the-timing-of-intubation-in-nasal-high-flow-100416826",false,"NCT04707729","ROX Index for the Timing of Intubation in Nasal High Flow","ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial","ROX-1","Inclusion Criteria:\n\n* All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.\n\n  * Criteria for initiation of NHF if they had a respiratory rate \\> 25 breaths\u002Fmin and\u002For pulse oximetry (SpO2) \\\u003C 92% while receiving standard oxygen administered through a facemask at 10 L\u002Fmn or more.\n  * Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Patients with indication for immediate intubation.\n* Patients treated with NHF for more than 1h prior to randomization.\n* Patients with do-not-intubate order.\n* Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).\n* Patients with no pulmonary infiltrates on chest X-ray\n* Patient with post-extubation AHRF.\n* Awake ECMO.\n* Pregnancy.\n* Refusal to participate or participation in another interventional study with the same primary outcome.","ALL","18 Years","120 Years",{"count":233,"type":234},630,"ESTIMATED","INTERVENTIONAL",[237],"NA","Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria.\n\nThe objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.",[240],"Acute Hypoxemic Respiratory Failure",[242,243,244],"High flow nasal cannula","Nasal high flow","High flow oxygen therapy","2024-08-12",{"date":247,"type":248},"2024-08-15","ACTUAL",{"date":250,"type":248},"2020-12-09",{"date":252,"type":234},"2025-06-30",{"name":5,"class":6},12]