[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549766":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Major mechanically ventilated patients intubated orotracheally",null,"The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage.",[13],"Device: EEG activity measurement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","EEG activity measurement","The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L\u002Fmin at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 31°C.\n\nSix 30-minute experimental conditions will be performed successively: 1) 0 L\u002Fmin flow, FiO2 21%, 2) 30 L\u002Fmin flow, FiO2 21%, 3) 30 L\u002Fmin flow, FiO2 100%, 4) 60 L\u002Fmin flow, FiO2 21%, 5) 60 L\u002Fmin flow, FiO2 100%, 6) Negative control.\n\nAt the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition.",[9],[21,22,23],"Post-intubation nasal ventilation","Additional blood samples (from care catheter 1.5 mL)","Electrical impedance tomography",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Martin Dres","CONTACT","0142167809","martin.dres@aphp.fr",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière","RECRUITING","Paris","75013","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":28,"phoneExt":47,"email":29},"Martin DRES, Pr","+33",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100549766","effects-of-nasal-ventilation-on-cerebral-and-pulmonary-function-in-orally-intubated-patients-100549766",false,"NCT06438302","Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients","VENTINA","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Hypoxemic acute respiratory failure\n3. Intubation and mechanical ventilation since less than 4 days\n4. PaO2\u002FFiO2 ratio less than 200\n5. RASS\\\u003C-4\n6. Consent obtained from next of kin\n7. Patient with health insurance\n\nExclusion Criteria:\n\n1. Central nervous system diseases (stroke, MS, epilepsy)\n2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)\n3. Hemodynamic instability (noradrenalin\\>2mg\u002Fh)\n4. Patient on AME\n5. Patients under legal protection (guardianship\u002Fcurators)\n6. Pregnant or breast-feeding women","ALL","18 Years",{"count":60,"type":61},22,"ESTIMATED","OBSERVATIONAL","The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation.\n\nThe hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.",[65],"Hypoxemic Acute Respiratory Failure",[67,68,69],"nasal ventilation","orotracheal intubation","brain activity","2025-12-02",{"date":72,"type":73},"2025-12-03","ACTUAL",{"date":75,"type":73},"2025-01-31",{"date":77,"type":61},"2028-02-01",{"name":5,"class":6},1]