[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530211":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":36,"responsibleParty":142,"collaborators":11,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":11,"enrollmentInfo":154,"targetDuration":11,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"the Oxygen Supply strategy","ACTIVE_COMPARATOR",null,[13],"Procedure: Emergency Medical Service intervention : Oxygen Supply strategy",{"label":15,"type":16,"description":11,"interventionNames":17},"the Continuous Positive Airway Pressure strategy","EXPERIMENTAL",[18],"Procedure: Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Emergency Medical Service intervention : Oxygen Supply strategy","During the 4-month period of control, the care teams will:\n\n\\- Use Oxygen Supply by face mask (15Liters\u002Fminutes) from pre-hospital to intensive care unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene).\n\nIndeed, current concepts of advanced prehospital care include the use of oxygen by face mask (15Liters\u002Fminutes) and intubation-Mechanical Ventilation in case of failure. The requirement of intubation-Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient;\n\n\\- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Oxygen Supply. The Oxygen Supply will be reduced progressively litter by litter each 12 hours period with maintenance of capillary saturation up to 92%.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy","During the 4-month period of experimentation, the care teams will:\n\n\\- Use Non-Invasive Ventilation by Continuous Positive Airway Pressure (set between 8 to 10 cm H2O) from pre-hospital setting to Intensive Care Unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene).\n\nThe requirement of Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient.\n\n\\- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Non-Invasive Ventilation-Continuous Positive Airway Pressure. Non-Invasive Ventilation-Continuous Positive Airway Pressure support will be weaned progressively (left at practitioners' convenience) with maintenance of capillary O2 saturation up to 92%.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Pierre Michelet, MD","CONTACT","638741313","+33","pierre.michelet@ap-hm.fr",[37,52,63,74,85,97,108,119,130],{"facility":38,"status":39,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centre Hospitalier de la Côte Basque - Urgences","RECRUITING","Bayonne","France","FR",{"type":44,"coordinates":45},"Point",[46,47],-1.473,43.49316,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":11,"phoneExt":11,"email":11},"LABES, MD",{"facility":53,"status":39,"city":54,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Groupe Hospitalier PELLEGRIN - SAMU-SMUR","Bordeaux",{"type":44,"coordinates":56},[57,58],-0.58046,44.84124,{"lat":58,"lon":57},[61],{"name":62,"role":32,"phone":11,"phoneExt":11,"email":11},"Bruno SIMONNET, MD",{"facility":64,"status":39,"city":65,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"CH La Rochelle - Urgence","La Rochelle",{"type":44,"coordinates":67},[68,69],-1.15222,46.16308,{"lat":69,"lon":68},[72],{"name":73,"role":32,"phone":11,"phoneExt":11,"email":11},"Ombeline SUSONG, MD",{"facility":75,"status":39,"city":76,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Centre Hospitalier Côte de Lumière - SAMU\u002FSMUR 85","Les Sables-d'Olonne",{"type":44,"coordinates":78},[79,80],-1.7847,46.49687,{"lat":80,"lon":79},[83],{"name":84,"role":32,"phone":11,"phoneExt":11,"email":11},"Stanislas BAWEJSKI, MD",{"facility":86,"status":87,"city":88,"state":11,"zip":89,"country":41,"countryCode":42,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"CHU Timone - APHM","NOT_YET_RECRUITING","Marseille","13005",{"type":44,"coordinates":91},[92,93],5.38107,43.29695,{"lat":93,"lon":92},[96],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"facility":98,"status":39,"city":99,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"CHU de Montpellier - Hôpital Lapeyronie","Montpellier",{"type":44,"coordinates":101},[102,103],3.87635,43.61093,{"lat":103,"lon":102},[106],{"name":107,"role":32,"phone":11,"phoneExt":11,"email":11},"Mustapha SEBBANE, MD",{"facility":109,"status":39,"city":110,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"CHU de Nantes - Urgences\u002FSAMU","Nantes",{"type":44,"coordinates":112},[113,114],-1.55336,47.21725,{"lat":114,"lon":113},[117],{"name":118,"role":32,"phone":11,"phoneExt":11,"email":11},"Emmanuel MONTASSIER, MD",{"facility":120,"status":39,"city":121,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"CHU Nice Hôpital Pasteur","Nice",{"type":44,"coordinates":123},[124,125],7.26608,43.70313,{"lat":125,"lon":124},[128],{"name":129,"role":32,"phone":11,"phoneExt":11,"email":11},"Céline OCCELLI, MD",{"facility":131,"status":39,"city":132,"state":11,"zip":133,"country":41,"countryCode":42,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"CHITS Hôpital Ste Musse","Toulon","83053",{"type":44,"coordinates":135},[136,137],5.92836,43.12442,{"lat":137,"lon":136},[140],{"name":141,"role":32,"phone":11,"phoneExt":11,"email":11},"Muriel Vergne, MD",{"type":143,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100530211","drowning-related-acute-respiratory-failure-100530211",false,"NCT06183827","Drowning-related Acute Respiratory Failure","Evaluation of Non-Invasive Ventilation\u002FContinuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure","CPAPDROWNING","Inclusion Criteria:\n\n* Man\u002Fboy or woman\u002Fgirl, 1yo and older.\n* Subject suffering from drowning related-Acute Respiratory Failure (whatever the nature of water, salt or fresh) and benefiting from the Emergency Medical Service intervention;\n* Acute Respiratory Failure defined as the presence of:\n\n  * Capillary O2 saturation \\\u003C92% upon Emergency Medical Service first clinical analysis at the drowning scene;\n  * Need for oxygen supply 15Liters\u002Fminutes to reach capillary O2 saturation ≥ 95%;\n  * Combination of Acute Respiratory Failure clinical signs: at least 1 of the following items: respiratory rate \\>30\u002Fmin, sternal or clavicular indrawing, abdominal breathing, cyanosis.\n* Individual affiliated to or beneficiary of a French health insurance system;\n* Individual with the ability to benefit from the two strategies (ambivalence clause);\n* Adult Individual having signed written informed consent or child subject with an authorization of the parents.\n\nExclusion Criteria:\n\n* Individual with hypothermia ≤ 34°C ;\n* Individual with neurological distress defined by a Glasgow Coma Scale \\\u003C 13 at first clinical assessment and during the first 15 minutes of care ;\n* Individual with hemodynamic distress defined by a systolic blood tension \\\u003C 90 mmHg at first clinical assessment and during the first 15 minutes of care ;\n* Cardiac arrest or respiratory arrest ;\n* Declared pregnancy or breastfeeding ;\n* Patient under legal protection regime for adults.","ALL","1 Year",{"count":155,"type":156},210,"ESTIMATED","INTERVENTIONAL",[159],"NA","The purpose of this study is to assess the Non-Invasive Ventilation-Continuous Positive Airway Pressure efficacy (experimental group) for drowning related Acute Respiratory Failure compared to Oxygen Supply by face mask (15Liters\u002Fminutes) (control group).",[162],"Drowning","2026-02-03",{"date":165,"type":166},"2026-02-06","ACTUAL",{"date":168,"type":166},"2024-07-24",{"date":170,"type":156},"2027-03",{"name":5,"class":6},9]