[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648783":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":41,"locations":41,"responsibleParty":50,"collaborators":41,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":41,"enrollmentInfo":61,"targetDuration":41,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":41,"overallStatus":70,"whyStopped":41,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":78,"locationsCount":41},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,15,19,23,27,31],{"label":9,"type":6,"description":10,"interventionNames":11},"TP\u002FHFO\u002FPSV","T piece follow by HFO follow by PSV",[12,13,14],"Device: T piece","Device: PSV","Device: HFO",{"label":16,"type":6,"description":17,"interventionNames":18},"TP\u002FPSV\u002FHFO","T piece follow by PSV follow by HFO",[12,13,14],{"label":20,"type":6,"description":21,"interventionNames":22},"PSV\u002FHFO\u002FTP","PSV follow by HFO follow by T piece",[12,13,14],{"label":24,"type":6,"description":25,"interventionNames":26},"PSV\u002FTP\u002FHFO","PSV follow by T piece follow by HFO",[12,13,14],{"label":28,"type":6,"description":29,"interventionNames":30},"HFO\u002FTP\u002FPSV","HFO follow by T piece follow by PSV",[12,13,14],{"label":32,"type":6,"description":33,"interventionNames":34},"HFO\u002FPSV\u002FTP","HFO follow by PSV follow by TP",[12,13,14],[36,42,46],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","T piece","The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery",[32,28,20,24,9,16],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"PSV","The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.",[32,28,20,24,9,16],{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"HFO","The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher \\& Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L\u002Fmin. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.",[32,28,20,24,9,16],{"type":51,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100648783","effect-of-high-flow-humidified-oxygen-on-ventilatory-work-during-the-spontaneous-breathing-trial-100648783",false,"NCT07724392","Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial","OTRAVAIL","Inclusion Criteria:\n\n* Adult patient, of legal age\n* On invasive mechanical ventilation for more than 48 hours\n* With at least one criterion indicating a high risk of extubation failure:\n\n  * Age \\> 65 years\n  * Chronic respiratory disease\n  * Chronic cardiac disease\n* Capable of undergoing a mechanical ventilation weaning test (\"weaning criterion\"):\n\n  * Respiratory rate \\\u003C 35 bpm\n  * Adequate oxygenation:\n\n    * SpO₂ ≥ 90% with FiO₂ ≤ 40% and PEEP ≤ 8 cm H₂O\n    * Or PaO₂\u002FFiO₂ ≥ 150 with PEEP ≤ 8 cm H₂O\n  * Effective cough\n  * Patient is alert (RASS score -2 to +1), without sedation\n  * Hemodynamically stable or on the minimum effective dose\n* Patient has an invasive arterial pressure catheter for arterial blood sampling\n* Informed consent signed by a family member\n* Patient is enrolled in or eligible for a social security program\n\nExclusion Criteria:\n\n* Resuscitation-associated neuromyopathy\n* History of neuromuscular disease\n* Admission for a neurological condition\n* Subjects currently excluded from another study,\n* Persons referred to in Articles L1121-5 through L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care facility for purposes other than research, minors, and persons subject to a legal protection order or unable to give informed consent).\n* Staff members who report to the principal investigator","ALL","18 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"NA","Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation.\n\nAn experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).",[69],"Spontaneous Breathing Trial in ICU","NOT_YET_RECRUITING","2026-07-20",{"date":73,"type":74},"2026-07-24","ACTUAL",{"date":76,"type":63},"2027-01",{"date":76,"type":63},{"name":5,"class":6}]