REBOA for Out-of-hospital Cardiac Arrest

Not Applicable

Withdrawn

• Conditions: Cardiac Arrest
• Interventions: Procedure: REBOA

• Registration Number: NCT04491903
• Lead Sponsor: neurescue

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-30
• Study Start: 2020-11-30
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REBOA	REBOA	-

Primary Outcome Measures

Name	Time	Method
Central blood pressure	1 hour

Secondary Outcome Measures

Name	Time	Method
Changes in cardiac rhythm following balloon inflation	1 hour
During procedure - time from first needle stick to successful sheath insertion	1 hour
During procedure - time from first needle stick to finalized balloon inflation	1 hour
Return of spontaneous circulation (ROSC)	1 hour
End-tidal CO2 (EtCO2)	1 hour