REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial

Jostein Rødseth Brede, Arne Kristian Skulberg, Marius Rehn, Kjetil Thorsen, Pål Klepstad, Ida Tylleskär, Bjørn Farbu, Jostein Dale, Trond Nordseth, Rune Wiseth, Andreas Jørstad Krüger, Jostein Rødseth Brede, Arne Kristian Skulberg, Marius Rehn, Kjetil Thorsen, Pål Klepstad, Ida Tylleskär, Bjørn Farbu, Jostein Dale, Trond Nordseth, Rune Wiseth, Andreas Jørstad Krüger

Abstract

Background: Survival after out-of-hospital cardiac arrest (OHCA) is poor and dependent on high-quality cardiopulmonary resuscitation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) may be advantageous in non-traumatic OHCA due to the potential benefit of redistributing the cardiac output to organs proximal to the aortic occlusion. This theory is supported by data from both preclinical studies and human case reports.

Methods: This multicentre trial will enrol 200 adult patients, who will be randomised in a 1:1 ratio to either a control group that receives advanced cardiovascular life support (ACLS) or an intervention group that receives ACLS and REBOA. The primary endpoint will be the proportion of patients who achieve return of spontaneous circulation with a duration of at least 20 min. The secondary objectives of this trial are to measure the proportion of patients surviving to 30 days with good neurological status, to describe the haemodynamic physiology of aortic occlusion during ACLS, and to document adverse events.

Discussion: Results from this study will assess the efficacy and safety of REBOA as an adjunctive treatment for non-traumatic OHCA. This novel use of REBOA may contribute to improve treatment for this patient cohort.

Trial registration: The trial is approved by the Regional Committee for Medical and Health Research Ethics in Norway (reference 152504) and is registered at ClinicalTrials.gov (reference NCT04596514) and as Universal Trial Number WHO: U1111-1253-0322.

Keywords: Advanced cardiopulmonary resuscitation (ACLS); Aortic occlusion; Cardiac arrest; Cardiopulmonary resuscitation (CPR); Resuscitative endovascular balloon occlusion of the aorta (REBOA); Return of spontaneous circulation (ROSC).

Conflict of interest statement

Dr Jostein Rødseth Brede, Dr Arne Kristian Skulberg, Dr Marius Rehn, Dr Andreas Jørstad Krüger, Dr Bjørn Farbu, Dr Ida Tylleskär, and Dr Kjetil Thorsen are partly employed for research purposes by the Norwegian Air Ambulance Foundation. Dr Trond Nordseth has received research funding from the same organisation. The other authors declare that they have no conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flow chart showing the patient allocation process. ACLS, advanced cardiovascular life support; REBOA, resuscitative endovascular balloon occlusion of the aorta
Fig. 2
Fig. 2
Illustration showing a REBOA balloon occluding the aorta in zone 1 after insertion of the catheter through the right femoral artery. REBOA, resuscitative endovascular balloon occlusion of the aorta
Fig. 3
Fig. 3
a Estimated sample size with return of spontaneous circulation as the primary endpoint. A horizontal line is drawn at the selected sample size of 100. ROSC, return of spontaneous circulation. b Estimated sample size with return of spontaneous circulation as the primary endpoint, compared to a control group with 25%, 20%, 15%, or 10% rate of ROSC. A horizontal line is drawn at the selected sample size of 100. ROSC, return of spontaneous circulation

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