Top

Published in:

Open Access 01-12-2024 | Cardiopulmonary Resuscitation | Methodology

Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial

Authors: Hee Eun Kim, Sheng-En Chu, You Hwan Jo, Wen-Chu Chiang, Dong-Hyun Jang, Chin-Hao Chang, So Hee Oh, Hsuan-An Chen, Seung Min Park, Jen-Tang Sun, Dong Keon Lee

Published in: Trials | Issue 1/2024

Abstract

Background

Out-of-hospital cardiac arrest (OHCA) is a significant public health issue worldwide and is associated with low survival rates and poor neurological outcomes. The generation of optimal coronary perfusion pressure (CPP) via high-quality chest compressions is a key factor in enhancing survival rates. However, it is often challenging to provide adequate CPP in real-world cardiopulmonary resuscitation (CPR) scenarios. Based on animal studies and human trials on improving CPP in patients with nontraumatic OHCA, resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising technique in these cases. This study aims to investigate the benefits of REBOA adjunct to CPR compared with conventional CPR for the clinical management of nontraumatic OHCA.

Methods

This is a parallel-group, randomized, controlled, multinational trial that will be conducted at two urban academic tertiary hospitals in Korea and Taiwan. Patients aged 20–80 years presenting with witnessed OHCA will be enrolled in this study. Eligible participants must fulfill the inclusion criteria, and written informed consent should be collected from their legal representatives. Patients will be randomly assigned to the intervention (REBOA-CPR) or control (conventional CPR) group. The intervention group will receive REBOA and standard advanced cardiovascular life support (ACLS). Meanwhile, the control group will receive ACLS based on the 2020 American Heart Association guidelines. The primary outcome is the return of spontaneous circulation (ROSC). The secondary outcomes include sustained ROSC, survival to admission, survival to discharge, neurological outcome, and hemodynamic changes.

Discussion

Our upcoming trial can provide essential evidence regarding the efficacy of REBOA, a mechanical method for enhancing CPP, in OHCA resuscitation. Our study aims to determine whether REBOA can improve treatment strategies for patients with nontraumatic OHCA based on clinical outcomes, thereby potentially providing valuable insights and guiding further advancements in this critical public health area.

Trial registration

ClinicalTrials.gov NCT06031623. Registered on September 9, 2023

Available only for authorised users

Kiguchi T, Okubo M, Nishiyama C, Maconochie I, Ong MEH, Kern KB, et al. Out-of-hospital cardiac arrest across the world: first report from the International Liaison Committee on Resuscitation (ILCOR). Resuscitation. 2020;152:39–49. https://doi.org/10.1016/j.resuscitation.2020.02.044.CrossRefPubMed

Soar J, Böttiger BW, Carli P, Couper K, Deakin CD, Djärv T, et al. European Resuscitation Council Guidelines 2021: adult advanced life support. Resuscitation. 2021;161:115–51. https://doi.org/10.1016/j.resuscitation.2021.02.010.CrossRefPubMed

Panchal AR, Bartos JA, Cabañas JG, Donnino MW, Drennan IR, Hirsch KG, et al. Part 3: Adult basic and advanced life support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020;142((16_suppl_2)):S366–468. https://doi.org/10.1161/CIR.0000000000000916.CrossRefPubMed

Bellamy RF, DeGuzman LR, Pedersen DC. Coronary blood flow during cardiopulmonary resuscitation in swine. Circulation. 1984;69(1):174–80. https://doi.org/10.1161/01.cir.69.1.174.CrossRefPubMed

Meaney PA, Bobrow BJ, Mancini ME, Christenson J, de Caen AR, Bhanji F, et al. Cardiopulmonary resuscitation quality: [corrected] improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation. 2013;128(4):417–35. https://doi.org/10.1161/CIR.0b013e31829d8654.CrossRefPubMed

Castellini G, Gianola S, Biffi A, Porcu G, Fabbri A, Ruggieri MP, et al. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled haemorrhagic shock: a systematic review with meta-analysis. World J Emerg Surg. 2021;16(1):41. https://doi.org/10.1186/s13017-021-00386-9.CrossRefPubMedPubMedCentral

Nowadly CD, Johnson MA, Hoareau GL, Manning JE, Daley JI. The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for non-traumatic cardiac arrest: a review. J Am Coll Emerg Physicians Open. 2020;1(5):737–43. https://doi.org/10.1002/emp2.12241.CrossRefPubMedPubMedCentral

Hutin A, Levy Y, Lidouren F, Kohlhauer M, Carli P, Ghaleh B, et al. Resuscitative endovascular balloon occlusion of the aorta vs epinephrine in the treatment of non-traumatic cardiac arrest in swine. Ann Intensive Care. 2021;11(1):81. https://doi.org/10.1186/s13613-021-00871-z.CrossRefPubMedPubMedCentral

Brede JR, Lafrenz T, Klepstad P, Skjærseth EA, Nordseth T, Søvik E, et al. Feasibility of pre-hospital resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest. J Am Heart Assoc. 2019;8(22): e014394. https://doi.org/10.1161/JAHA.119.014394.CrossRefPubMedPubMedCentral

10.

Jang DH, Lee DK, Jo YH, Park SM, Oh YT, Im CW. Resuscitative endovascular occlusion of the aorta (REBOA) as a mechanical method for increasing the coronary perfusion pressure in non-traumatic out-of-hospital cardiac arrest patients. Resuscitation. 2022;179:277–84. https://doi.org/10.1016/j.resuscitation.2022.07.020.CrossRefPubMed

11.

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346: e7586. https://doi.org/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

12.

World Medical A. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4. https://doi.org/10.1001/jama.2013.281053.CrossRef

13.

Foëx BA. The problem of informed consent in emergency medicine research. Emerg Med J. 2001;18(3):198–204. https://doi.org/10.1136/emj.18.3.198.CrossRefPubMedPubMedCentral

14.

Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med. 1999;6(12):1272–82. https://doi.org/10.1111/j.1553-2712.1999.tb00144.x.CrossRefPubMed

15.

Otlewski MP, Geddes LA, Pargett M, Babbs CF. Methods for calculating coronary perfusion pressure during CPR. Cardiovasc Eng. 2009;9(3):98–103. https://doi.org/10.1007/s10558-009-9079-y.CrossRefPubMed

16.

Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, et al. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals from a task force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care. Perioperative and Resuscitation Resuscitation. 2015;96:328–40. https://doi.org/10.1016/j.resuscitation.2014.11.002.CrossRefPubMed

17.

Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975;1(7905):480–4. https://doi.org/10.1016/s0140-6736(75)92830-5.CrossRefPubMed

18.

Reynolds JC, Salcido DD, Menegazzi JJ. Coronary perfusion pressure and return of spontaneous circulation after prolonged cardiac arrest. Prehosp Emerg Care. 2010;14(1):78–84. https://doi.org/10.3109/10903120903349796.CrossRefPubMedPubMedCentral

19.

Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, et al. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in non-traumatic cardiac arrest: a narrative review of known and potential physiological effects. J Clin Med Res. 2022;11(3):4–6. https://doi.org/10.3390/jcm11030742.

20.

Olsen MH, Olesen ND, Karlsson M, Holmlöv T, Søndergaard L, Boutelle M, et al. Randomized blinded trial of automated REBOA during CPR in a porcine model of cardiac arrest. Resuscitation. 2021;160:39–48. https://doi.org/10.1016/j.resuscitation.2021.01.010.CrossRefPubMed

21.

Brede JR, Skulberg AK, Rehn M, Thorsen K, Klepstad P, Tylleskär I, Farbu B, Dale J, Nordseth T, Wiseth R, Krüger AJ. 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. Trials. 2021;22(1):511.CrossRefPubMedPubMedCentral

22.

Jansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, Gillies K, Cotton S, Kennedy C, Boyers D, Ferry G. Emergency department resuscitative endovascular balloon occlusion of the aorta in trauma patients with exsanguinating hemorrhage: the UK-REBOA randomized clinical trial. JAMA. 2023;330(19):1862–71.CrossRefPubMed

Title: Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial
Authors: Hee Eun Kim
Sheng-En Chu
You Hwan Jo
Wen-Chu Chiang
Dong-Hyun Jang
Chin-Hao Chang
So Hee Oh
Hsuan-An Chen
Seung Min Park
Jen-Tang Sun
Dong Keon Lee
Publication date: 01-12-2024
Publisher: BioMed Central
Keyword: Cardiopulmonary Resuscitation
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-07928-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study

Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial

The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT

DON in pediatric cerebral malaria, a phase I/IIA dose-escalation safety study: study protocol for a clinical trial