Cardiac Arrest, Out-Of-Hospital, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
cardiac arrest, out of hospital cardiac arrest, REBOA
Brief summary
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).
Detailed description
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.
Interventions
DEVICEResuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device
In-hospital use of a REBOA catheter device during advanced cardiac life support
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None. Masking is not possible.
Intervention model description
A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to successful deployment of device | Up to 10 minutes | The device is successfully deployed when it raises the mean arterial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return of spontaneous circulation (ROSC) | Up to 60 minutes | ROSC is when the heart begins beating on its own |
Outcome results
None listed