[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ORIXHA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Cardiac Arrest","Post Cardiac Arrest Syndrome",[29,30,31,32,33,34,35],"Cooling","Targeted Temperature Management","ROSC","Resuscitated Cardiac Arrest","Out of Hospital cardiac arrest","Therapeutic Hypothermia","liquid ventilation","NOT_YET_RECRUITING","2025-01-28",{"date":39,"type":40},"2025-01-29","ACTUAL",{"date":42,"type":20},"2025-03",{"date":44,"type":20},"2026-03",{"name":46,"class":47},"ORIXHA","INDUSTRY",""]