[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530144":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":51,"centralContacts":56,"locations":64,"responsibleParty":89,"collaborators":42,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":42,"enrollmentInfo":101,"targetDuration":42,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":115,"whyStopped":42,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"ADIR Association","OTHER",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"NIV + CPAP + HFO","EXPERIMENTAL","The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],"Device: Noninvasive mechanical ventilation","Device: Nasal high-flow oxygen therapy","Device: Continuous positive airway pressure",{"label":17,"type":10,"description":18,"interventionNames":19},"NIV + HFO + CPAP","The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"CPAP + NIV + HFO","The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"CPAP + HFO + NIV","The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"HFO + CPAP + NIV","The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"HFO + NIV + CPAP","The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.",[13,14,15],[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Noninvasive mechanical ventilation","Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.",[25,21,29,33,9,17],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Nasal high-flow oxygen therapy","Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.",[25,21,29,33,9,17],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Continuous positive airway pressure","Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.",[25,21,29,33,9,17],[52],{"name":53,"affiliation":54,"role":55},"Elise ARTAUD-MACARI, MD","University Hospital, Rouen","PRINCIPAL_INVESTIGATOR",[57,61],{"name":53,"role":58,"phone":59,"phoneExt":42,"email":60},"CONTACT","+33232885992","elise.artaud-macari@chu-rouen.fr",{"name":62,"role":58,"phone":59,"phoneExt":42,"email":63},"Maryline LEFORT","mlefort@adir-hautenormandie.com",[65],{"facility":5,"status":42,"city":66,"state":42,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Rouen","76000","France","FR",{"type":71,"coordinates":72},"Point",[73,74],1.09932,49.44313,{"lat":74,"lon":73},[77,78,81,83,85,87],{"name":53,"role":58,"phone":59,"phoneExt":42,"email":60},{"name":79,"role":80,"phone":42,"phoneExt":42,"email":42},"David DEBEAUMONT, MD","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":42,"phoneExt":42,"email":42},"Christophe GIRAULT, MD",{"name":84,"role":80,"phone":42,"phoneExt":42,"email":42},"Antoine CUVELIER, MD, PHD",{"name":86,"role":80,"phone":42,"phoneExt":42,"email":42},"Pierre Alexandre ROGER, MD",{"name":88,"role":80,"phone":42,"phoneExt":42,"email":42},"Gurvan LEBOUAR, MD",{"type":90,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100530144","niv-versus-hfo-for-acute-exacerbations-of-interstitial-lung-diseases-100530144",false,"NCT06182956","NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases","Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases","IRAPIDPhysio","Inclusion criteria:\n\n* Age \\> 18 yrs\n* Hospitalization in intensive care unit\n* Acute exacerbation of a previously\u002Fpresently documented diffuse (fibrotic) interstitial lung disease\n* Dyspnea majoration since at least 1 month\n* Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload\n* Hypoxemia requiring oxygen flows \\> 6 L\u002Fmin\n\nExclusion criteria:\n\n* Contraindication to noninvasive ventilation or high-flow oxygen therapy\n* Immediate indication to endotracheal intubation or hemodynamic assistance\n* Body mass index \\> 40\n* Presence of a pacemaker or an implantable defibrillator\n* Presence of cutaneous lesions where Pulmovista® belt should be placed\n* Moribund patient\n* Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception\n* Protected adult patient (tutorship or curatorship)\n* Patient deprived of liberty by court or administrative decision\n* No possibility to install nasogastric tube\n* Endotracheal or tracheostomy tube requirement during the study\n* Hemodynamic assistance requirement during the study","ALL","18 Years",{"count":102,"type":103},18,"ESTIMATED","INTERVENTIONAL",[106],"NA","The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.",[109,110],"Interstitial Lung Disease","Acute Respiratory Failure",[39,44,112,113,114],"Respiratory work","Hemodynamics","Diaphragm","NOT_YET_RECRUITING","2023-12-13",{"date":118,"type":119},"2023-12-27","ACTUAL",{"date":121,"type":103},"2024-01-01",{"date":123,"type":103},"2026-12-31",{"name":5,"class":6},1]