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Withdrawn
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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.
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:
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REBOA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBOA | Procedure | Endovascular balloon occlusion of the aorta |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central blood pressure | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Return of spontaneous circulation (ROSC) | 1 hour | |
| Changes in cardiac rhythm following balloon inflation | 1 hour | |
| During procedure - time from first needle stick to successful sheath insertion |
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Inclusion Criteria:
Exclusion Criteria:
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Individual request
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 hour |
| During procedure - time from first needle stick to finalized balloon inflation | 1 hour |
| End-tidal CO2 (EtCO2) | 1 hour |