Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)

University of Alabama at Birmingham

Overview

Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).

Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device. The aims of UPFRONT are: 1. To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA 2. To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cardiac Arrest, Out-Of-Hospital Ventricular Fibrillation Ventricular Tachycardia

Interventions

Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter deviceDEVICE

In-hospital use of a REBOA catheter device during advanced cardiac life support

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Apparent age between 18 - 70 years. 2. OHCA defined as receiving professional CPR or AED defibrillation 3. OHCA witnessed by bystanders or professional rescuers / UED personnel 4. VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA 5. Total time pulseless \> 10 minutes Exclusion Criteria: 1. Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living 2. Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.) 3. Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest 4. Do-Not-Resuscitate order or comfort care measures in place prior to enrollment 5. Special populations (pregnant, prisoner, or cognitively impaired) 6. Total time pulseless greater than 20 minutes 7. Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since

Outcomes

Primary Outcomes

Time to successful deployment of device

The device is successfully deployed when it raises the mean arterial pressure

Time frame: Up to 10 minutes

Secondary Outcomes

Return of spontaneous circulation (ROSC)

ROSC is when the heart begins beating on its own

Time frame: Up to 60 minutes

Data from ClinicalTrials.gov

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