Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest
NCT Number: NCT06537492
Acronym: GRAVITY2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Arrest|Cardiac Arrest, Out-Of-Hospital|Cardiopulmonary Arrest|Cardiopulmonary Resuscitation
Interventions: PROCEDURE: REBOA|DEVICE: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)|DEVICE: Mechanical Chest Compression Device with Active Chest Decompression|DEVICE: Impedance Threshold Device
Sponsor: University Hospital, Grenoble
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-01
Locations: University Hospital Grenoble, Grenoble, 38043, France

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.

Primary Outcome Measures: Mean Arterial Pressure (MAP), Difference in mean arterial pressure (MAP) over a 5s period before the initiation of balloon inflation compared 3 minutes after initiation of balloon inflation in a patient treated with AHUP-CPR, Baseline
Secondary Outcome Measures: End-Tidal CO2 (EtCO2), Comparison of End-Tidal CO2 (EtCO2) value before and after REBOA placement., Baseline|Compression arterial pressure (CP), Comparison of compression arterial pressure (CP) before and after REBOA placement, Baseline|Decompression arterial pressure (DAP), Decompression arterial pressure (DAP) before and after REBOA placement, Baseline|Brain regional O2 saturation (rSO2), Comparison of brain regional O2 saturation (rSO2) value before and after REBOA placement, Baseline|Return to spontaneous circulation (ROSC)., Number and percentage of return to spontaneous circulation (ROSC)., Baseline, 30-day, 3 months|Patients discharged alive., Number and percentage of patients discharged alive., 30-day|Survival, Number and percentage of 30-day and 3 months survival., 30-day, 3 months|Neurological status, Neurological status (Cerebral Performance Category (CPC) score and Modified Rankin Scale (MRS) score) at 30-day and 3 months., 30-day, 3 months|REBOA Placement, To assess REBOA placement successful rate, Baseline|Blood vessel damage, To assess secondary effects of REBOA placement: number of patients with blood vessel damage requiring surgical or endovascular intervention, 30-day|Arterial thromboembolism, To assess secondary effects of REBOA placement: number of patients with arterial thromboembolism requiring surgical or endovascular intervention,, 30-day|Lower extremity amputation, To assess secondary effects of REBOA placement: number of patients with lower extremity amputation, 30-day|Renal failure, To assess secondary effects of REBOA placement: number of patients with renal failure requiring non-temporary dialysis, 30-day|Lower extremity paralysis, To assess secondary effects of REBOA placement: number of patients with lower extremity paralysis., 30-day|Ventilatory parameter: flow, To assess flow (L/min) during head-up CPR., Out-of-hospital care|Ventilatory parameter: tidal volume, To assess tidal volume adjusted on predicted body weight (mL/PBW) during head-up CPR., Out-of-hospital care|Ventilatory parameter: airway pressure, To assess airway pressure (cmH2O) during head-up CPR., Out-of-hospital care