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NCT04491903 Clinical Trial

REBOA for Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:
REBOA for Out-of-hospital Cardiac Arrest

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04491903
Other study ID # SafeStudy2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date November 30, 2020

Study information
Verified date April 2021
Source neurescue
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved. The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.

Description:

The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study. Data collected: - from enrolment of the patient until hospital arrival - every 24 hours - at discharge or 7 days post enrollment - at 30 days post enrollment The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Witnessed cardiac arrest - Bystander or professional CPR within 5 minutes - Refractory cardiac arrest Exclusion Criteria: - End Tidal CO2 <1,3 kPa - Traumatic cardiac arrest - Women with known pregnancy - Patients with known terminal disease - Patients with known do-not-attempt-CPR order - Patients with overdose

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• REBOA
Endovascular balloon occlusion of the aorta

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
neurescue

Outcome
Type Measure Description Time frame Safety issue
Primary Central blood pressure 1 hour
Secondary Return of spontaneous circulation (ROSC) 1 hour
Secondary Changes in cardiac rhythm following balloon inflation 1 hour
Secondary During procedure - time from first needle stick to successful sheath insertion 1 hour
Secondary During procedure - time from first needle stick to finalized balloon inflation 1 hour
Secondary End-tidal CO2 (EtCO2) 1 hour
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