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Resuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

NCT03534011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-11

No results posted yet for this study

Summary

The primary aim of this study is to investigate the feasibility and complications of inserting a REBOA-catheter to patients suffering from non-traumatic out-of-hospital cardiac arrest, by anesthesiologist working in the pre-hospital setting. The study will include patients in the catchment population of St. Olavs University Hospital, Trondheim area, Norway. The REBOA technique (resuscitative balloon occlusion of the aorta) is a well-known treatment used on other indications, both in-hospital and pre-hospital. It has also been utilized in several animal studies on non-traumatic cardiac arrest and has shown to augment myocardial and cerebral perfusion during cardio-pulmonary resuscitation. There are no systematic studies on humans with REBOA in non-traumatic cardiac arrest. The study will also investigate the time needed to perform a REBOA procedure in cardiac arrest patients receiving advanced cardiac life support. This additional treatment might contribute to increase the survival rate of cardiac arrest patients.

Conditions

  • Out-of-Hospital Cardiac Arrest

Interventions

PROCEDURE

Resuscitative Balloon Occlusion of the Aorta

If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS) is established, a REBOA catheter is inserted via the femoral artery and the aortic balloon inflated, according to a procedure described in a separate document. Ultrasound is used to limit risk related to cannulation and placement of the guidewire.

DEVICE

REBOA catheter

Catheter with a Resuscitative Balloon for Occlusion of the Aorta

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian Air Ambulance Foundation

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Sindre Mellesmo, md · St. Olavs Hospital

  • Jostein Rødseth Brede, md · St. Olavs Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Norway

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 NCT03534011 on ClinicalTrials.gov