Using REBOA to improve outcomes in out-of-hospital cardiac arrest
CPR-REBOA: Improving Outcome of Prehospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
This study is testing whether a new method using a special balloon during CPR can help people who have a cardiac arrest outside of the hospital survive and have better brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04373122 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) during cardiopulmonary resuscitation (CPR) for patients experiencing out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin. The approach aims to enhance blood flow to the heart and brain by clamping the descending aorta, potentially improving survival rates and neurological outcomes. Patients eligible for this intervention are those who do not achieve return of spontaneous circulation (ROSC) within 10 minutes of standard advanced life support. The study will assess the effectiveness of this method compared to traditional CPR techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are adults suffering from refractory out-of-hospital cardiac arrest of presumed cardiac origin who do not qualify for extracorporeal cardiac life support.
Not a fit: Patients with advanced directives excluding CPR, those with underlying diseases limiting survival, or those qualifying for other treatment options like eCPR may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and neurological outcomes for patients experiencing out-of-hospital cardiac arrest.
How similar studies have performed: While the use of REBOA in cardiac arrest is a novel approach, animal models have shown promising results, indicating potential for success in human applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from refractory Out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin, defined as failure to achieve stable ROSC within 10 min of fully established standard care (ALS) which do not qualify for extracorporeal cardiac life support (e-CPR). * Witnessed Arrest * Interval from collapse to initiation of sufficient (lay) CPR less than 5 minutes Exclusion Criteria: * Patients whose underlying disease limit survival and resuscitation measures are stopped after initial assessment, or evaluation reveals futile clinical situation * Patients with advanced directives or living will which excludes CPR * Age \< 18 years (device certified \>18 years) * Qualifying for other treatment options, namely eCPR (CPR with extracorporeal membrane oxygenation (ECMO) as life assist device) * Unwitnessed arrest with asystole as first documented rhythm * etCO2 below 15mmHg * Patients in whom no femoral arterial access site cannot accommodate a 7 Fr (minimum) introducer sheath * Known to have an aortic diameter larger than 32 mm * Evidence or suspicion of thoracic trauma * Inability to guarantee standard ALS measures during performance of the REBOA maneuver
Where this trial is running
Bern
- Departement of Intensive Care Medicine - University Hospital Bern - Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Anja Levis, MD — University of Bern, Inselspital
- Study coordinator: Anja Levis, MD
- Email: Anja.Levis@insel.ch
- Phone: +41316327855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.