Study Comparing NEURESCUE Device Use with Standard Advanced Cardiac Life Support in Adults with Cardiac Arrest

What this Trial Is About

This trial investigates cardiac arrest treatment by comparing standard Advanced Cardiovascular Life Support ACLS alone to ACLS combined with aortic balloon occlusion ABO using the NEURESCUE device. The study aims to evaluate the clinical safety and performance of adding ABO, an emergency method that quickly directs blood flow to the heart and brain during cardiac arrest, potentially improving outcomes. Participants are randomly assigned to one of two groups one receiving standard ACLS treatment, which includes CPR, airway management, ventilation, and defibrillation, and the other receiving ACLS plus ABO using the NEURESCUE device. The NEURESCUE catheter is inserted via the femoral artery into the descending aorta and temporarily inflates a balloon to redirect blood flow. The NEURESCUE Assistant controls pressure-regulated inflation and deflation of the balloon during treatment. Throughout the study, cardiac rhythm and return of spontaneous circulation are closely monitored. Participants will have four visits, including a 90-day follow-up to assess outcomes. Researchers will measure resuscitation success, epinephrine use, procedures, adverse events, neurological function via CPC score, quality of life with EQ-5D, and survival. The study runs from randomization through 90 days post cardiac arrest to evaluate safety and performance.

A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support