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.
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 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.
Single group
REBOA
Procedure/SurgeryThe 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. The 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.
Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)
DeviceConventional CPR will be performed using an automated head and chest elevation device during cardiopulmonary resuscitation (AHUP-CPR).
Mechanical Chest Compression Device with Active Chest Decompression
DeviceIn addition to head and thorax elevation, mechanical chest compression will be performed with active chest compression-decompression using a specific mechanical chest compression device.
Impedance Threshold Device
DeviceIn addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device.
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
End-Tidal CO2 (EtCO2)
Comparison of End-Tidal CO2 (EtCO2) value before and after REBOA placement.
Compression arterial pressure (CP)
Comparison of compression arterial pressure (CP) before and after REBOA placement
Decompression arterial pressure (DAP)
Decompression arterial pressure (DAP) before and after REBOA placement
Brain regional O2 saturation (rSO2)
Comparison of brain regional O2 saturation (rSO2) value before and after REBOA placement
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