[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652044":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":16,"centralContacts":27,"locations":37,"responsibleParty":178,"collaborators":16,"id":180,"slug":181,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":182,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":16,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":206,"whyStopped":16,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEEP + PSV","EXPERIMENTAL","Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)",[13],"Procedure: Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)",{"label":15,"type":6,"description":16,"interventionNames":17},"Induction in spontaneous breathing",null,[18],"Procedure: Induction in spontaneous breathing",[20,24],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":16},"PROCEDURE","Sevoflurane will initially be at 6% (with a fresh gas flow between 2L\u002Fmin and 10L\u002Fmin) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation.\n\nIn the experimental group, the level of PEEP will be set at 5 cmH2O and inspiratory support between 2 and 12 cmH2O and adjusted by the anaesthetist in charge to optimize respiratory mechanics and obtain a physiological tidal volume of 8ml\u002Fkg.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":16},"Sevoflurane will initially be at 6% (with a fresh gas flow between 2L\u002Fmin and 10L\u002Fmin) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation.\n\nIn the control group, there is no PEEP",[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":16,"email":32},"Florent BAUDIN, Pr","CONTACT","+00334 72 12 97 35","florent.baudin@chu-lyon.fr",{"name":34,"role":30,"phone":35,"phoneExt":16,"email":36},"Clarisse Saunier","+0033427856264","clarisse.saunier@chu-lyon.fr",[38,59,74,89,105,120,132,148,163],{"facility":39,"status":16,"city":40,"state":16,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hôpital Femme Mère Enfant","Lyon","69677","France","FR",{"type":45,"coordinates":46},"Point",[47,48],4.84789,45.74906,{"lat":48,"lon":47},[51,55,57],{"name":52,"role":30,"phone":53,"phoneExt":16,"email":54},"Eloise Cercueil, Dr","+00334 27 85 52 48","Eloise.cercueil@chu-lyon.fr",{"name":56,"role":30,"phone":31,"phoneExt":16,"email":32},"Florent Baudin, Pr",{"name":52,"role":58,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":16,"city":61,"state":16,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hôpitaux Universitaires de Marseille Timone","Marseille","13385",{"type":45,"coordinates":64},[65,66],5.38107,43.29695,{"lat":66,"lon":65},[69,73],{"name":70,"role":30,"phone":71,"phoneExt":16,"email":72},"Fabrice Michel, Dr","+334.91.96.47.58","fabrice.michel@ap-hm.fr",{"name":70,"role":58,"phone":16,"phoneExt":16,"email":16},{"facility":75,"status":16,"city":76,"state":16,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Centre Hospitalier Universitaire de Montpellier","Montpellier","34295",{"type":45,"coordinates":79},[80,81],3.87635,43.61093,{"lat":81,"lon":80},[84,88],{"name":85,"role":30,"phone":86,"phoneExt":16,"email":87},"Chrystelle SOLA, Dr","(+33)4 67 33 24 48","c-sola@chu-montpellier.fr",{"name":85,"role":58,"phone":16,"phoneExt":16,"email":16},{"facility":90,"status":16,"city":91,"state":16,"zip":92,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CHU de Nantes","Nantes","44000",{"type":45,"coordinates":94},[95,96],-1.55336,47.21725,{"lat":96,"lon":95},[99,103],{"name":100,"role":30,"phone":101,"phoneExt":16,"email":102},"Jules LECOMTE, Dr","(+33) 2 40 08 32 50","jules.lecomte@chu-nantes.fr",{"name":104,"role":58,"phone":16,"phoneExt":16,"email":16},"Jules Lecomte, Dr",{"facility":106,"status":16,"city":107,"state":16,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hôpital Armand Trousseau","Paris","75012",{"type":45,"coordinates":110},[111,112],2.3488,48.85341,{"lat":112,"lon":111},[115,119],{"name":116,"role":30,"phone":117,"phoneExt":16,"email":118},"Mireille Nasr, Dr","+00331 44 73 51 20","mireille.nasr@aphp.fr",{"name":116,"role":58,"phone":16,"phoneExt":16,"email":16},{"facility":121,"status":16,"city":107,"state":16,"zip":122,"country":42,"countryCode":43,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Hôpital Robert Debré","75019",{"type":45,"coordinates":124},[111,112],{"lat":112,"lon":111},[127,131],{"name":128,"role":30,"phone":129,"phoneExt":16,"email":130},"Souhayl DAHMANI, Dr","(+33)1 40 03 22 21","souhayl.dahmani@rdb.aphp.fr",{"name":128,"role":58,"phone":16,"phoneExt":16,"email":16},{"facility":133,"status":16,"city":134,"state":16,"zip":135,"country":42,"countryCode":43,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Centre Hospitalier Universitaire de Reims","Reims","51092",{"type":45,"coordinates":137},[138,139],4.02853,49.26526,{"lat":139,"lon":138},[142,146],{"name":143,"role":30,"phone":144,"phoneExt":16,"email":145},"Delphine Michelet, Dr","(+33)3 26 83 25 37","dmichelet@chu-reims.fr",{"name":147,"role":58,"phone":16,"phoneExt":16,"email":16},"Delpine Michelet, Dr",{"facility":149,"status":16,"city":150,"state":16,"zip":151,"country":42,"countryCode":43,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hôpital de Hautepierre","Strasbourg","67200",{"type":45,"coordinates":153},[154,155],7.74553,48.58392,{"lat":155,"lon":154},[158,162],{"name":159,"role":30,"phone":160,"phoneExt":16,"email":161},"Claire BOPP, Dr","(+33) 3 88 12 61 38","claire.bopp@chru-strasbourg.fr",{"name":159,"role":58,"phone":16,"phoneExt":16,"email":16},{"facility":164,"status":16,"city":165,"state":16,"zip":166,"country":42,"countryCode":43,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"CHU Toulouse - Hôpitaux des enfants","Toulouse","31300",{"type":45,"coordinates":168},[169,170],1.44367,43.60426,{"lat":170,"lon":169},[173,177],{"name":174,"role":30,"phone":175,"phoneExt":16,"email":176},"Delhpine KERN, Dr","(+33)5 34 55 84 23","kern.d@chu-toulouse.fr",{"name":174,"role":58,"phone":16,"phoneExt":16,"email":16},{"type":179,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100652044","two-modalities-of-ventilation-on-the-occurrence-of-respiratory-complications-during-inhalational-anaesthetic-induction-in-children-100652044",false,"NCT07767851","Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children","Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.","PEDIAMOVE","Inclusion Criteria:\n\n* Child between 3 months and 6 years old\n* Without significant comorbidity (ASA 1 or 2)\n* Admitted for elective or emergency\u002Furgent surgery under general anesthesia\n* With induction of anaesthesia by inhalation by sevoflurane on the machine circuit\n* With airway control by intubation tube or supraglottic device\n* Consent of at least one parent or legal guardian\n\nExclusion Criteria:\n\n* Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery\n* Thoracic surgery with selective control of intubation\n* Criteria for difficult intubation or known history of difficult intubation\n* Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia)\n* Children asking for intravenous induction or requiring rapid sequence induction\n* Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…)\n* Children not affiliated or beneficiary of a health insurance system\n* Children participating in other interventional research with an exclusion period still in progress at inclusion\n\nExclusion Criteria :\n\n* Failure of venous access after 30 min or more than 5 attempts\n* Parents' consent withdrawal","ALL","3 Months","6 Years",{"count":192,"type":193},2032,"ESTIMATED","INTERVENTIONAL",[196],"NA","Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line.\n\nSerious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation \\\u003C 95%, airway obstruction) are included.\n\nTraditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC).\n\nOur hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications.\n\nThe primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.",[199,200,201,202],"Anaesthetic Induction","Respiratory Complications of Care","Pediatrics","Ventilation",[204,202,205,201],"Anaesthetic induction","Respiratory complications","NOT_YET_RECRUITING","2026-08-11",{"date":209,"type":210},"2026-08-17","ACTUAL",{"date":212,"type":193},"2026-09-01",{"date":214,"type":193},"2029-09-01",{"name":5,"class":6},9]