Using a special balloon technique to help patients in cardiac arrest before they reach the hospital
Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest
This study is testing a special balloon technique to see if it can help people who have a cardiac arrest outside of the hospital before they get medical help.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (Norwich) |
| Trial ID | NCT06071910 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) for patients experiencing non-traumatic out-of-hospital cardiac arrest (OHCA). It aims to gather insights into the technical execution of this procedure during resuscitation attempts and assess its physiological benefits. A total of twenty patients will be enrolled, and the study follows the IDEAL framework Stage 2a1 to test and stabilize the intervention before larger trials. The findings could inform future multi-center randomized studies on this technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who experience non-traumatic out-of-hospital cardiac arrest and have the East Anglian Air Ambulance REBOA team in attendance.
Not a fit: Patients with traumatic cardiac arrest, known terminal illnesses, or severe co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients experiencing out-of-hospital cardiac arrest.
How similar studies have performed: While this approach is novel in the pre-hospital setting, similar techniques have shown promise in controlled environments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Non-Traumatic OHCA in patients within the East of England area AND with a East Anglian Air Ambulance (EAAA) REBOA team in attendance * Patients below or equal to 80yrs of age and above or equal to 18yrs of age, according to available information/estimate at scene * No flow \<10 mins from data available (i.e. total period in OHCA with no CPR) * In cardiac arrest (with no sustained ROSC) on arrival of the EAAA REBOA team Exclusion criteria * Patients aged less than 18 or above 80 years * Known terminal illness * Multiple severe co-morbidities * Traumatic Cardiac Arrest (TCA) * Inability to deploy mechanical CPR (e.g. LUCAS Device) * Pregnancy, obvious or suspected
Where this trial is running
Norwich
- East Anglian Air Ambulance — Norwich, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Paul Rees, MD(Res)
- Email: paul.rees@eaaa.org.uk
- Phone: 07976 406496
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.