[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607498":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).\n\nNIV alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy.\n\nApneic oxygenation will be used with HFNO at the time of laryngoscopy after removing the facemask of NIV (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0)",[13],"Procedure: Apneic oxygenation",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.",[18],"Procedure: Usual Care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Apneic oxygenation","* Preoxygenation will be performed using NIV for 3-5 min With nasal cannulas placed in standby beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0)\n* Rapide sequence induction\n* Hypoventilation phase will be continue for 1 min using NIV\n* At the time of laryngoscopy :\n\nAfter removing the facemask, the nasal cannulas of HFNO will be placed in the patient's nares then the laryngoscopy will be performed.\n\n\\* Use of capnography to confirm the success of procedure",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","* Preoxygenation will be performed using NIV for 3-5 min without HFNO\n* Rapide sequence induction\n* Hypoventilation phase will be continue using NIV for 1min\n* At the time of laryngoscopy :\n\nAfter removing the facemask, laryngoscopy will be performed without oxygen.\n\n\\* Use of capnography to confirm the success of procedure",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Mai-Anh Nay, MD","CONTACT","+33 2 38 57 52 53","mainah.nay@chu-orleans.fr",[37],{"facility":38,"status":25,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"CHRU de Tours","Tours","37000","France","FR",{"type":44,"coordinates":45},"Point",[46,47],0.70398,47.39484,{"lat":47,"lon":46},[50,54,56],{"name":51,"role":33,"phone":52,"phoneExt":25,"email":53},"Amélie DELAGE","+33 2 47 47 39 33","a.delage@chu-tours.fr",{"name":25,"role":33,"phone":25,"phoneExt":25,"email":55},"cpcq@chu-tours.fr",{"name":32,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100607498","apneic-oxygenation-with-high-flow-nasal-oxygenation-after-preoxygenation-with-noninvasive-ventilation-before-intubation-in-hypoxemic-patients-in-intensive-care-unit-100607498",false,"NCT07189338","Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.","APNEIC","Inclusion Criteria:\n\n* Patient admitted in the ICU\n* Indication of orotracheal intubation for Hypoxemic acute respiratory failure defined by:\n\n  * One sign of acute respiratory distress (respiratory rate \\>25\u002Fmin, dyspnea or the use of accessory respiratory muscle)\n  * AND a PaO2\u002FFiO2 ≤ 200 mmHg (measured or calculated FiO2) within 6 hours before the decision of intubation. For the calculation of FiO2, the FiO2 will be estimated by: FiO2 = 0.21 + 0.03 x (flow of oxygen) (Coudroy, Thorax 2020)\n* Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.\n\nExclusion Criteria:\n\n* \\\u003C 18 years old\n\n  * Need for emergent intubation (i.e. cardiac arrest)\n  * Contraindication to non-invasive ventilation for preoxygenation\n  * Known allergy or contraindication to one of the induction drugs\n  * SpO2 device specific for the study not available\n  * Patients without any healthcare insurance scheme or not benefiting from it through a third party,\n  * Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision\n  * Previous participation in the study","ALL","18 Years",{"count":70,"type":71},500,"ESTIMATED","INTERVENTIONAL",[74],"NA","The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.\n\nThe sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.\n\nParticipants will be enrolled according to eligibility criteria and randomized into one of the following groups:\n\nExperimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).\n\nnon-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.\n\nAt the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.\n\nControl group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.",[77],"Hypoxemic Acute Respiratory Failure",[79,80,81],"IUC","Hypoxemic acute respiratory failure","HFNO","NOT_YET_RECRUITING","2025-09-17",{"date":85,"type":86},"2025-09-23","ACTUAL",{"date":88,"type":71},"2025-10-30",{"date":90,"type":71},"2028-11-30",{"name":5,"class":6},1]