Status:
UNKNOWN
REBOA in Out-of-hospital Cardiac Arrest
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
City of Bern
Conditions:
Out-of-Hospital Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Unexpected cardiac arrest is a frequent and devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephal...
Detailed Description
Unexpected cardiac arrest is a devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy (HIE)....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04373122
Start Date
June 7 2021
End Date
December 31 2025
Last Update
March 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Bern, Switzerland, 3010