[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613127":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":48,"overallOfficials":53,"centralContacts":57,"locations":67,"responsibleParty":88,"collaborators":90,"id":93,"slug":29,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":29,"maxAge":100,"enrollmentInfo":101,"targetDuration":29,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":70,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of the two methods of measuring airway opening pressure","The method will be considered feasible if at least one maneuver out of three allows a measurement of the airway opening pressure to be obtained.","5 years",[14,17,21,23,26],{"measure":15,"description":16,"timeFrame":12},"Prevalence of airway opening pressure","Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.",{"measure":18,"description":19,"timeFrame":20},"Value of airway opening pressure with each of the two measurement methods","Value of airway opening pressure with each of the two measurement methods of the study","1 day",{"measure":22,"description":22,"timeFrame":20},"Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure",{"measure":24,"description":25,"timeFrame":12},"Description of the tolerance of the two methods of measuring airway opening pressure","Description of the tolerance of the two methods of measuring airway opening pressure using the following parameters: minimum SpO2 value (%), variations in heart rate (HR, \u002Fmin), systolic ans diastolic blood pressure (mmHg), expired CO2 (mmHg).",{"measure":27,"description":28,"timeFrame":12},"Duration of the methods","Duration of each method",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NON_RANDOMIZED","CROSSOVER","DIAGNOSTIC",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","Acute respiratory distress syndrome (ARDS) in children is associated with significant morbidity and mortality. Current studies seek to individualize the management of children by defining several phenotypes, based until now mainly on clinical presentation. A better understanding of the respiratory mechanics of each patient could allow the individualization of other phenotypes and adapt their management with individualized ventilation. The method for detecting airway opening pressure (AOP) in children has not yet been validated and the reference methods in adults are difficult to apply in children due to their physiological particularities.\n\nThe main objective of the study is to evaluate the feasibility of two methods for measuring airway opening pressure in invasively ventilated pediatric patients: \"pediatric slow flow method\" based on a recent bench study and \"fixed flow method\" based on an adult study. The two methods will be separated by a wash out.\n\nThe method will be considered feasible if at least one on three measures can be interpretated.\n\nAir flow will be recorded using a pneumotachograph connected to a T piece.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Measurement of airway opening pressure with pediatric slow flow method on first","EXPERIMENTAL","Measurement of airway opening pressure in invasively ventilated pediatric patients with \"pediatric slow flow method\" on first and \"fixed flow method\" in a second time.",[43],"Other: Measurement of airway opening pressure",{"label":45,"type":40,"description":46,"interventionNames":47},"Measurement of airway opening pressure with fixed flow method on first","Measurement of airway opening pressure in invasively ventilated pediatric patients with \"fixed flow method\" on first and \"pediatric slow flow method\" in a second time.",[43],[49],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":29},"Measurement of airway opening pressure","Measurement of airway opening pressure in invasively ventilated pediatric patients with 2 methods, \"fixed flow method\" and \"pediatric slow flow method\". The two methods will be separated by a washout period. The order of the airway opening pressure detection methods will be random.",[45,39],[54],{"name":55,"affiliation":5,"role":56},"Charlotte Collignon, M.D.","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":29,"email":62},"Charlotte COLLIGNON, MD","CONTACT","00330144495890","charlotte.collignon@aphp.fr",{"name":64,"role":60,"phone":65,"phoneExt":29,"email":66},"Hélène Morel","0033171196346","helene.morel@aphp.fr",[68],{"facility":69,"status":70,"city":71,"state":29,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Hôpital Necker-Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":76,"coordinates":77},"Point",[78,79],2.3488,48.85341,{"lat":79,"lon":78},[82,85],{"name":83,"role":60,"phone":84,"phoneExt":29,"email":62},"Charlotte Collignon, MD","003344495890",{"name":86,"role":60,"phone":84,"phoneExt":29,"email":87},"Meryl Vedrenne-Cloquet, M.D.","meryl.vedrenne@aphp.fr",{"type":89,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[91],{"name":92,"class":6},"URC-CIC Paris Descartes Necker Cochin","100613127",false,"NCT07262541","Assessment of Airway Opening Pressure in Invasively Ventilated Children","AOP-KID","Inclusion Criteria:\n\n* Minor patients weighing more than 5 kg, hospitalized in the pediatric intensive care unit at Necker-Enfants Malades Hospital and receiving invasive ventilation. To assess patients with acute respiratory distress syndrome, the PALICC-2 criteria are used.\n* Holders of parental authority must be informed and consent to their child's participation in the study.\n* The patient must be passively ventilated to ensure reliable measurements. This means that the patient must not be spontaneously ventilating and must be completely passively ventilated by the ventilator (no respiratory effort during long-term inflation).\n\nExclusion Criteria:\n\n* Respiratory mechanics preventing interpretation of maneuvers (flow too low and\u002For resistance too high)\n* Patient \\\u003C 5 kg\n* Refusal by those with parental authority\n* Patient not affiliated with social security\n* Patient receiving AME (Medical Aid for Life)\n* Contraindication or impossibility of performing static respiratory mechanics measurements: pneumothorax or pleural leak, head trauma or threatening HTIC, unstable patient with SpO2 \\\u003C 88%, patient receiving nitric oxide (NO) (circuit leaks) or other circuit leaks or patient leaks \\> 20% displayed on the ventilator","ALL","17 Years",{"count":102,"type":103},50,"ESTIMATED","INTERVENTIONAL",[106],"NA","Acute respiratory distress syndrome (ARDS) in children is associated with significant morbidity and mortality. Current studies seek to individualize the management of children by defining several phenotypes, based until now mainly on clinical presentation. A better understanding of the respiratory mechanics of each patient could allow the individualization of other phenotypes and adapt their management with individualized ventilation. The method for detecting airway opening pressure (AOP) in children has not yet been validated and the reference methods in adults are difficult to apply in children due to their physiological particularities.\n\nThe main objective of the study is to evaluate the feasibility of two methods for measuring airway opening pressure in invasively ventilated pediatric patients.",[109],"Acute Respiratory Distress Syndrome in Children",[111,112,113,114],"Acute respiratory distress syndrome","Invasively ventilated children","Airway opening pressure (AOP) detection","Children","2026-06-29",{"date":117,"type":118},"2026-06-30","ACTUAL",{"date":120,"type":118},"2026-02-02",{"date":122,"type":103},"2031-02",{"name":5,"class":6},1]