[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577478":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"ORIXHA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with Vent2Cool device","EXPERIMENTAL","Vent2Cool is to be used to perform induction of Ultra-Rapid Therapeutic Hypothermia for the patients. The hypothermia maintenance and rewarming phases will be performed with an external TTM device as currently used in the investigation centres.",[13],"Device: Ultra-rapid therapeutic hypothermia induction by total liquid ventilation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Ultra-rapid therapeutic hypothermia induction by total liquid ventilation","Vent2Cool System is a targeted temperature management device used to induce ultra-rapid therapeutic hypothermia by total liquid ventilation.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sandrine Perrotto, PhD","CONTACT","+33187666102","clinical.affairs@orixha.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Fabrice Paublant","+33660767729","paublant@orixha.com",[32],{"facility":33,"status":20,"city":34,"state":20,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hopital Cochin - Service de Medecine intensive et reanimation au 27 rue du Faubourg Saint-Jacques","Paris","75014","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":20,"phoneExt":20,"email":20},"Alain Cariou, M.D.","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100577478","lung-conservative-liquid-ventilation-for-the-induction-of-ultra-rapid-cooling-after-cardiac-arrest-100577478",false,"NCT06798818","Lung-cOnservative Liquid VEntilation for the Induction of Ultra-Rapid COOLing After Cardiac Arrest","OverCool","Inclusion Criteria:\n\n* Patient resuscitated after extra- or intra-hospital cardiac arrest, from presumed cardiac or asphyxial origin, regardless of the heart rate initially recorded.\n* Age between 18 and 84 years old\n* Time between collapse and return of spontaneous circulation (ROSC) \\\u003C 60 min\n* Presumption, at the time of inclusion, of a possibility of starting Vent2Cool within a period of less than 120 min after ROSC.\n* Unconscious (GCS \\\u003C8, not able to obey verbal commands after sustained ROSC)\n* Patient affiliated with a social security system (If applicable)\n* Consent of the member of patients' family or that of the trusted person if present and able to understand; otherwise certificate of emergency inclusion in compliance with applicable regulations.\n* Vent2Cool must be connected to a standard cuffed ETT of 7.0 mm to 9.0 mm internal diameter for the procedure.\n\nExclusion Criteria:\n\n* Conscious patient\n* Patient Ideal Body Weight less than 40 kgs or more than 93 kgs\n* Traumatic cardiac arrest, drowning, exsanguination, or sepsis\n* Temperature at admission \\\u003C 34.0°C\n* Need for veno-arterial extracorporeal circulation (Extracorporeal membrane of oxygenation, ECMO) before return of spontaneous circulation (refractory cardiac arrest)\n* One of the following signs at echocardiography at hospital admission:\n\n  * Acute cor pulmonale, defined by right ventricular enlargement with interventricular septal deviation, associated with a Tricuspid Annular Plane Systolic Excursion (TAPSE) \\\u003C 12 mm and need for vasopressor agents\n  * Time-velocity integral of subaortic flow \\\u003C 10 m\u002Fs\n* Wrong positioning or damage of the endotracheal tube.\n* Women under 50 years old (childbearing age) or for women of \\>50 years old, a positive pregnancy test (urinary) in case of pregnancy suspicion by the investigator. Possible breastfeeding during the study.\n* Suspicion of intracranial bleeding\n* History of severe Chronic Obstructive Pulmonary Disease (COPD) with long-term home oxygen therapy\n* Acute respiratory pathology (pneumothorax, pleurisy, pneumonia, suspicion of contusion or intra-pulmonary hemorrhage following resuscitation)\n* COVID-19 positive test in case of clinical suspicion and\u002For epidemic context\n* Excessive mucus in the upper airways\n* Patient presenting at least one of the following criteria in the mechanical ventilation parameters at inclusion:\n\n  * PEEP \\> 8 cm H2O\n  * Plateau pressure\\> 25 cmH2O\n  * Driving pressure\\> 15cmH2O\n* Patient with at least one of the following criteria at inclusion:\n\n  * PaO2\\\u003C 80 mmHg\n  * PaO2 \u002F FiO2\\\u003C 150 mmHg\n  * PaCO2\\> 48 mmHg","ALL","18 Years","84 Years",{"count":61,"type":62},24,"ESTIMATED","INTERVENTIONAL",[65],"NA","Out-of-hospital cardiac arrest (OHCA) affects over 356,000 individuals annually in the United States, with fewer than 10% surviving to hospital discharge, mirroring statistics from Europe. Post-cardiac arrest syndrome (PCAS), a condition causing multi-organ dysfunction, is a leading cause of mortality despite successful resuscitation efforts. Targeted temperature management (TTM) is recommended for comatose patients post-resuscitation to mitigate PCAS, but optimal temperature targets and cooling methods remain unclear. Experimental studies suggest that therapeutic hypothermia (32-34°C), induced rapidly after resuscitation, may provide significant clinical benefits.\n\nTotal liquid ventilation (TLV) with breathable liquids has been proposed to achieve ultra-rapid therapeutic hypothermia (URTH). This approach uses the lungs as a heat exchanger to achieve ultra-rapid cooling while maintaining normal gas exchange. It enables a reduction in core body temperature to the hypothermic range (33.0 ± 0.5°C) within 45 minutes in relevant experimental models.\n\nThe OverCool study is an open-label, single-arm, multi-centric pilot trial designed to evaluate the performance and safety of Vent2Cool, a medical device intended to induce ultra-rapid therapeutic hypothermia by TLV in resuscitated cardiac arrest patients. The primary objective is to demonstrate Vent2Cool's ability to achieve a target core temperature of 33.0 ± 0.5°C within 60 minutes from start of procedure in resuscitated patients admitted to the Intensive Care Unit following intra- or extra-hospital cardiac arrest. Secondary objectives include assessing procedural safety, cooling performance, feasibility in emergency settings, clinical outcomes, and the impact on biological markers.",[68,69],"Cardiac Arrest","Post Cardiac Arrest Syndrome",[71,72,73,74,75,76,77],"Cooling","Targeted Temperature Management","ROSC","Resuscitated Cardiac Arrest","Out of Hospital cardiac arrest","Therapeutic Hypothermia","liquid ventilation","NOT_YET_RECRUITING","2025-01-28",{"date":81,"type":82},"2025-01-29","ACTUAL",{"date":84,"type":62},"2025-03",{"date":86,"type":62},"2026-03",{"name":5,"class":6},1]