In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta (CPReboa)

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Cardiac Arrest

Treatments: Other: Advanced Cardiac Life Support (ACLS); Device: resuscitative endovascular occlusion of the aorta (REBOA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07434726

CPReboa

Details and patient eligibility

About

This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.

Full description

Patients with in-hospital cardiac arrest (IHCA) outside the operating room, the coronary angiography suite and the intensive care unit (ICU) will be attended to by the hospitals resuscitation team and provided with advanced cardiac life support (ACLS) as per usual practice.

A research team will be deployed simultaneously and, when patients meet inclusion criteria, will randomize patients to ACLS alone or to ACLS plus balloon occlusion of the descending thoracic aorta by means of a resuscitative endovascular occlusion of the aorta (REBOA) catheter.

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
• successful placement of a femoral artery introducer sheath
• any electrical cardiac activity seen in the initial rhythm analysis
• ongoing effort of resuscitation as determined by study-independent resuscitation lead

Exclusion criteria

• IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
• hospital visitors suffering from cardiac arrest
• asystole seen in the initial rhythm analysis
• (presumed) age under 18 years
• known "do not resuscitate"-order
• known or obvious pregnancy
• traumatic cardiac arrest
• known aortic pathologies that render cannulation impossible
• known allergies to radiographic contrast agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Advanced Cardiac Life Support (ACLS) alone

Active Comparator group

Description:

Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR).

Treatment:

Other: Advanced Cardiac Life Support (ACLS)

Advanced Cardiac Life Support (ACLS) plus REBOA

Experimental group

Description:

Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA).

Treatment:

Device: resuscitative endovascular occlusion of the aorta (REBOA)

Other: Advanced Cardiac Life Support (ACLS)