[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557390":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":40,"centralContacts":44,"locations":55,"responsibleParty":76,"collaborators":22,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":22,"enrollmentInfo":88,"targetDuration":22,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":103,"whyStopped":22,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"REBOA","EXPERIMENTAL","In this quasi-experimental pilot study, a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) will be introduced by a specifically dedicated team with physicians trained in this practice. In order to allow a chance for return of spontaneous circulation (ROSC) with standard care, REBOA will be placed after 10 minutes of conventional CPR. Conventional CPR will be performed using innovative devices to enhance circulation and cerebral perfusion pressure during CPR, including progressive elevation of the head and thorax, an active chest compression device, and an impedance threshold valve.",[13,14,15,16],"Procedure: REBOA","Device: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)","Device: Mechanical Chest Compression Device with Active Chest Decompression","Device: Impedance Threshold Device",[18,23,28,34],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","The REBOA device used in this study will be a computer-aided aortic balloon occlusion catheter with safety feedback and automatic inflation and deflation. The device will be used to temporarily inflate a balloon in the descending aorta through a femoral artery introducer sheath which, when inflated, redirects blood flow to the central circulation.\n\nThe REBOA will be inserted into the aorta via the femoral artery through an introducer sheath. Once positioned, the balloon will be inflated to occlude the aorta. The REBOA assistant will be attached to the patient's skin with the adhesive on the underside of the assistant.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DEVICE","Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)","Conventional CPR will be performed using an automated head and chest elevation device during cardiopulmonary resuscitation (AHUP-CPR).",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Mechanical Chest Compression Device with Active Chest Decompression","In addition to head and thorax elevation, mechanical chest compression will be performed with active chest compression-decompression using a specific mechanical chest compression device.",[9],[33],"ACD",{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Impedance Threshold Device","In addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device.",[9],[39],"ITD",[41],{"name":42,"affiliation":5,"role":43},"Guillaume Pr Debaty, MD, PhD","PRINCIPAL_INVESTIGATOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Mandzo Aida","CONTACT","0476766816","+33","amandzo@chu-grenoble.fr",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Johanna Boeuf, MSc","0476634256","jboeuf1@chu-grenoble.fr",[56],{"facility":57,"status":22,"city":58,"state":22,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University Hospital Grenoble","Grenoble","38043","France","FR",{"type":63,"coordinates":64},"Point",[65,66],5.71479,45.17869,{"lat":66,"lon":65},[69,71,72,73],{"name":42,"role":47,"phone":53,"phoneExt":49,"email":70},"gdebaty@chu-grenoble.fr",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},{"name":42,"role":43,"phone":22,"phoneExt":22,"email":22},{"name":74,"role":75,"phone":22,"phoneExt":22,"email":22},"Nicolas Dr Segond, MD","SUB_INVESTIGATOR",{"type":77,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100557390","synergy-of-elevation-of-the-head-and-thorax-and-reboa-during-out-of-hospital-cardiac-arrest-100557390",false,"NCT06537492","Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest","Synergy of Elevation of the Head and Thorax and Resuscitative Endovascular Balloon Occlusion of the Aorta During Out-of-Hospital Cardiac Arrest: a Pilot Study","GRAVITY2","Inclusion Criteria:\n\n* Patient with age over or equal to 18 years old\n* Patient with a witnessed medical cardiac arrest and with a no-flow duration under 10 min\n* Patient with EtCO2 greater than 20 mmHg at REBOA team arrival\n* Patient located in the Grenoble Metropolitan area\n* Patient affiliated to French social security\n\nExclusion Criteria:\n\n* Patient with ROSC before REBOA placement.\n* Patient eligible to extracorporeal life support (according to local guidelines).\n* CA of traumatic origin (including drowning or hanging).\n* Patients whose size is not adapted to the LUCAS device: height of the sternum from 170 to 303 mm or maximum chest width of 449 mm. The use of the LUCAS device is not subject to a patient weight condition.\n* Cardiac arrest for which resuscitation seems unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, advance personal directives of no-resuscitation).\n* Obvious pregnancy at inclusion.\n* Subject in a period of exclusion from another clinical investigation.\n* Patients with a femoral arterial access site that cannot accommodate an 8 Fr (minimum) introduces sheath","ALL","18 Years",{"count":89,"type":90},35,"ESTIMATED","INTERVENTIONAL",[93],"NA","Long-term neurological outcome after successful resuscitation of cardiac arrest remains poor, mainly due to cerebral hypoperfusion and severe hypoxic-ischemic brain injuries. Automated head and chest elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing the intracranial pressure and increasing cerebral perfusion in experimental pig studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression device (ACD) improved hemodynamics and cerebral perfusion. In addition, early implementation of AHUP-CPR in patients with out-of-hospital cardiac arrest (OHCA) was associated with improved survival to hospital discharge, in a multicenter observational study. A 2-year prospective clinical trial in Grenoble evaluating this combination was just completed. This study showed for the first time that the value of end-tidal CO2 (EtCO2), a surrogate for cardiopulmonary resuscitation (CPR) quality and cardiac output, measured with this combination therapy, was significantly higher than with standard CPR.\n\nResuscitative endovascular balloon occlusion of the aorta (REBOA) has recently been proposed during CPR. This technique temporarily diverts blood flow to the coronary and cerebral circulation. Its beneficial effect on hemodynamics, cerebral blood flow and survival has been experimentally validated. In several feasibility studies, encouraging results were observed by slightly optimizing cerebral perfusion and coronary pressure when REBOA was used in combination with standard CPR.\n\nIn a porcine model of cardiac arrest, the addition of REBOA to AHUP CPR was associated with a marked improvement in coronary perfusion pressure and near-normalization of cerebral perfusion pressure. These two interventions act synergistically. REBOA directs flow and pressure to the heart and brain, while AHUP CPR improves preload on the right side of the heart and reduces intracranial pressure.\n\nThe aims of this clinical investigation are to assess the feasibility of placing a REBOA catheter combined with automated CPR with head and chest elevation, and to quantify the associated changes in clinical parameters for OHCA.",[96,97,98,99],"Heart Arrest","Cardiac Arrest, Out-Of-Hospital","Cardiopulmonary Arrest","Cardiopulmonary Resuscitation",[101,102],"Resuscitative endovascular balloon","Head-up cardiopulmonary resuscitation","NOT_YET_RECRUITING","2024-07-31",{"date":106,"type":107},"2024-08-05","ACTUAL",{"date":109,"type":90},"2024-10",{"date":111,"type":90},"2026-01",{"name":5,"class":6},1]