Not Yet RecruitingNot Applicable

Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest

France35 participantsStarted 2024-10

Plain-language summary

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. Resuscitative 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. In 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. The 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patient with age over or equal to 18 years old * Patient with a witnessed medical cardiac arrest and with a no-flow duration under 10 min * Patient with EtCO2 greater than 20 mmHg at REBOA team arrival * Patient located in the Grenoble Metropolitan area * Patient affiliated to French social security Exclusion Criteria: * Patient with ROSC before REBOA placement. * Patient eligible to extracorporeal life support (according to local guidelines). * CA of traumatic origin (including drowning or hanging). * 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. * 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). * Obvious pregnancy at inclusion. * Subject in a period of exclusion from another clinical investigation. * Patients with a femoral arterial access site that cannot accommodate an 8 Fr (minimum) introduces sheath

What they're measuring

Mean Arterial Pressure (MAP)

Timeframe: Baseline

Trial details

NCT IDNCT06537492

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

Contact for this trial

Mandzo Aida

0476766816 amandzo@chu-grenoble.fr