Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Arrest
- Sponsor
- neurescue
- Primary Endpoint
- Central blood pressure
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Central blood pressure
Time Frame: 1 hour
Secondary Outcomes
- 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)