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Feasibility of REBOA in Refractory Cardiac Arrest

NCT03664557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-03

No results posted yet for this study

Summary

Outcome after non-traumatic cardiac arrest remains poor despite many efforts in improving immediate advanced life support (ALS) and post-arrest therapy. Preserving myocardial and cerebral perfusion in the event of cardiac arrest by the means of effective cardio-pulmonary resuscitation (CPR) is of utmost importance. During CPR, coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. The absence of ROSC despite prolonged high quality and efficient initial basic life support (BLS) followed by traditional ALS ends finally in neuronal damage and death. Occlusion of the aorta using a REBOA catheter in the management of noncompressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. Before testing such an approach in humans, the safe and reliable placement procedure of the catheter-balloon in humans after cardiac arrest needs to be established under ongoing CPR.

Conditions

  • Heart Arrest

Interventions

DEVICE

ER Reboa TM Catheter

During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Anja Levis, MD · Dep of Intensive Care Medicine, University Hospital Bern

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664557 on ClinicalTrials.gov