Cardiopulmonary resuscitation with balloon occlusion of the descending aorta for hospitalized patients
CPReboa: In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
This trial will test whether adding a balloon occlusion of the descending aorta (REBOA) to standard ACLS helps people having an in-hospital cardiac arrest regain and keep a pulse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07434726 on ClinicalTrials.gov |
What this trial studies
Adults who have an in-hospital cardiac arrest outside the operating room, ICU, or cath lab and who meet inclusion criteria will be randomized during active resuscitation to receive standard advanced cardiac life support (ACLS) alone or ACLS plus placement of a REBOA catheter to occlude the descending thoracic aorta. A research team deploys simultaneously with the clinical resuscitation team, and femoral artery access must be obtained to allow randomization. The primary focus is frequency of sustained return of spontaneous circulation (ROSC); secondary care, imaging contrast risks, and exclusion criteria such as asystole, pregnancy, known DNR, traumatic arrest, or prohibitive aortic pathology are pre-specified. The intervention is performed in-hospital with immediate monitoring and standard post-ROSC care.
Who should consider this trial
Good fit: Ideal candidates are adult patients with ongoing in-hospital cardiac arrest (including those who re-arrest after OHCA in the ED) who have any electrical cardiac activity on initial rhythm analysis and in whom femoral arterial access can be achieved while resuscitation continues.
Not a fit: Patients with asystole on initial rhythm, traumatic arrest, known DNR orders, pregnancy, prohibitive aortic pathology, or inability to obtain femoral access are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding REBOA could increase the chances of sustained return of circulation during in-hospital cardiac arrest and potentially improve survival and neurologic outcomes.
How similar studies have performed: REBOA has shown benefit in traumatic hemorrhage and some animal and small human studies suggest it can raise coronary perfusion during CPR, but randomized human data for nontraumatic cardiac arrest is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA) * successful placement of a femoral artery introducer sheath * any electrical cardiac activity seen in the initial rhythm analysis * ongoing effort of resuscitation as determined by study-independent resuscitation lead Exclusion criteria: * IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory * hospital visitors suffering from cardiac arrest * asystole seen in the initial rhythm analysis * (presumed) age under 18 years * known "do not resuscitate"-order * known or obvious pregnancy * traumatic cardiac arrest * known aortic pathologies that render cannulation impossible * known allergies to radiographic contrast agents
Where this trial is running
Bern
- Inselspital University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Wolf E Hautz, MD, MME — Inselspital University Hospital Bern
- Study coordinator: Wolf E Hautz, MD, MME
- Email: wolf.hautz@insel.ch
- Phone: +41 31 632 57 01
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.