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

Norwegian University of Science and Technology

Status: Completed

Conditions: Out-of-Hospital Cardiac Arrest

Treatments: Procedure: Resuscitative Balloon Occlusion of the Aorta; Device: REBOA catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03534011

2018/51

Details and patient eligibility

About

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.

Full description

If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS as described in the present guidelines from the Norwegian Resuscitation Council) 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. The ultrasound images will be stored and later processed by the principal investigator. If the physician experiences technical problems during the procedure (i.e. severe difficulties in establishing vascular access, resistance during insertion of the guidewire, introducer or balloon catheter, severe bleeding, prolonged time consumption) the effort will be aborted. If ROSC is achieved, the aortic balloon is deflated gently. If the patient re-enters cardiac arrest, the normal ACLS-guideline is followed. The balloon is then re-inflated, as described in the procedure.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-traumatic cardiac arrest
• Witnessed cardiac arrest
• Less than 10 minutes from observed cardiac arrest to start of basic or advanced cardiac life support (BCLS/ACLS)

Exclusion criteria

• Traumatic cardiac arrest, including patients rescued from avalanches
• Hypothermic patients, including drowning
• Pregnancy
• End-stage terminal illness
• Suspected neurologic injury as the etiology of the arrest
• Strangulations
• Other factors as decided by the treating physician

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

REBOA

Experimental group

Description:

Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved

Treatment:

Procedure: Resuscitative Balloon Occlusion of the Aorta

Device: REBOA catheter