Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest

NCT06537492 | Not Yet Recruiting

• 1 other identifier: 38RC23.0224
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term neurological outcome after successful resuscitation of cardiac arrest remains poor, mainly due to cerebral hypoperfusion and severe hypoxic-ischemic brain injuries. Automated head and chest elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing the intracranial pressure and increasing cerebral perfusion in experimental pig studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression device (ACD) improved hemodynamics and cerebral perfusion. In addition, early implementation of AHUP-CPR in patients with out-of-hospital cardiac arrest (OHCA) was associated with improved survival to hospital discharge, in a multicenter observational study. A 2-year prospective clinical trial in Grenoble evaluating this combination was just completed. This study showed for the first time that the value of end-tidal CO2 (EtCO2), a surrogate for cardiopulmonary resuscitation (CPR) quality and cardiac output, measured with this combination therapy, was significantly higher than with standard CPR. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has recently been proposed during CPR. This technique temporarily diverts blood flow to the coronary and cerebral circulation. Its beneficial effect on hemodynamics, cerebral blood flow and survival has been experimentally validated. In several feasibility studies, encouraging results were observed by slightly optimizing cerebral perfusion and coronary pressure when REBOA was used in combination with standard CPR. In a porcine model of cardiac arrest, the addition of REBOA to AHUP CPR was associated with a marked improvement in coronary perfusion pressure and near-normalization of cerebral perfusion pressure. These two interventions act synergistically. REBOA directs flow and pressure to the heart and brain, while AHUP CPR improves preload on the right side of the heart and reduces intracranial pressure. The aims of this clinical investigation are to assess the feasibility of placing a REBOA catheter combined with automated CPR with head and chest elevation, and to quantify the associated changes in clinical parameters for OHCA.

Conditions

Heart Arrest; Cardiac Arrest, Out-Of-Hospital; Cardiopulmonary Arrest; Cardiopulmonary Resuscitation

Keywords

Resuscitative endovascular balloon; Head-up cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure (MAP)

  Difference in mean arterial pressure (MAP) over a 5s period before the initiation of balloon inflation compared 3 minutes after initiation of balloon inflation in a patient treated with AHUP-CPR

  Baseline

Secondary Outcomes (17)

• End-Tidal CO2 (EtCO2)

  Baseline

• Compression arterial pressure (CP)

  Baseline

• Decompression arterial pressure (DAP)

  Baseline

• Brain regional O2 saturation (rSO2)

  Baseline

• Return to spontaneous circulation (ROSC).

  Baseline, 30-day, 3 months

Study Arms (1)

REBOA

EXPERIMENTAL

In this quasi-experimental pilot study, a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) will be introduced by a specifically dedicated team with physicians trained in this practice. In order to allow a chance for return of spontaneous circulation (ROSC) with standard care, REBOA will be placed after 10 minutes of conventional CPR. Conventional CPR will be performed using innovative devices to enhance circulation and cerebral perfusion pressure during CPR, including progressive elevation of the head and thorax, an active chest compression device, and an impedance threshold valve.

Procedure: REBOA; Device: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR); Device: Mechanical Chest Compression Device with Active Chest Decompression; Device: Impedance Threshold Device

Interventions

REBOA PROCEDURE

The REBOA device used in this study will be a computer-aided aortic balloon occlusion catheter with safety feedback and automatic inflation and deflation. The device will be used to temporarily inflate a balloon in the descending aorta through a femoral artery introducer sheath which, when inflated, redirects blood flow to the central circulation. The REBOA will be inserted into the aorta via the femoral artery through an introducer sheath. Once positioned, the balloon will be inflated to occlude the aorta. The REBOA assistant will be attached to the patient's skin with the adhesive on the underside of the assistant.

REBOA

Head-Up Cardiopulmonary Resuscitation (AHUP-CPR) DEVICE

Conventional CPR will be performed using an automated head and chest elevation device during cardiopulmonary resuscitation (AHUP-CPR).

REBOA

Mechanical Chest Compression Device with Active Chest Decompression DEVICE

In addition to head and thorax elevation, mechanical chest compression will be performed with active chest compression-decompression using a specific mechanical chest compression device.

Also known as: ACD

REBOA

Impedance Threshold Device DEVICE

In addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device.

Also known as: ITD

REBOA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with age over or equal to 18 years old
• Patient with a witnessed medical cardiac arrest and with a no-flow duration under 10 min
• Patient with EtCO2 greater than 20 mmHg at REBOA team arrival
• Patient located in the Grenoble Metropolitan area
• Patient affiliated to French social security

You may not qualify if:

• Patient with ROSC before REBOA placement.
• Patient eligible to extracorporeal life support (according to local guidelines).
• CA of traumatic origin (including drowning or hanging).
• Patients whose size is not adapted to the LUCAS device: height of the sternum from 170 to 303 mm or maximum chest width of 449 mm. The use of the LUCAS device is not subject to a patient weight condition.
• Cardiac arrest for which resuscitation seems unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, advance personal directives of no-resuscitation).
• Patients with a femoral arterial access site that cannot accommodate an 8 Fr (minimum) introduces sheath

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (12)

• Perkins GD, Callaway CW, Haywood K, Neumar RW, Lilja G, Rowland MJ, Sawyer KN, Skrifvars MB, Nolan JP. Brain injury after cardiac arrest. Lancet. 2021 Oct 2;398(10307):1269-1278. doi: 10.1016/S0140-6736(21)00953-3. Epub 2021 Aug 26.

  PMID: 34454687 BACKGROUND

• Duhem H, Moore JC, Rojas-Salvador C, Salverda B, Lick M, Pepe P, Labarere J, Debaty G, Lurie KG. Improving post-cardiac arrest cerebral perfusion pressure by elevating the head and thorax. Resuscitation. 2021 Feb;159:45-53. doi: 10.1016/j.resuscitation.2020.12.016. Epub 2020 Dec 29.

  PMID: 33385469 BACKGROUND

• Ryu HH, Moore JC, Yannopoulos D, Lick M, McKnite S, Shin SD, Kim TY, Metzger A, Rees J, Tsangaris A, Debaty G, Lurie KG. The Effect of Head Up Cardiopulmonary Resuscitation on Cerebral and Systemic Hemodynamics. Resuscitation. 2016 May;102:29-34. doi: 10.1016/j.resuscitation.2016.01.033. Epub 2016 Feb 22.

  PMID: 26905388 BACKGROUND

• Moore JC, Salverda B, Rojas-Salvador C, Lick M, Debaty G, G Lurie K. Controlled sequential elevation of the head and thorax combined with active compression decompression cardiopulmonary resuscitation and an impedance threshold device improves neurological survival in a porcine model of cardiac arrest. Resuscitation. 2021 Jan;158:220-227. doi: 10.1016/j.resuscitation.2020.09.030. Epub 2020 Oct 4.

  PMID: 33027619 BACKGROUND

• Moore JC, Salverda B, Lick M, Rojas-Salvador C, Segal N, Debaty G, Lurie KG. Controlled progressive elevation rather than an optimal angle maximizes cerebral perfusion pressure during head up CPR in a swine model of cardiac arrest. Resuscitation. 2020 May;150:23-28. doi: 10.1016/j.resuscitation.2020.02.023. Epub 2020 Feb 27.

  PMID: 32114071 BACKGROUND

• Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.

  PMID: 26562060 BACKGROUND

• Moore JC, Pepe PE, Scheppke KA, Lick C, Duval S, Holley J, Salverda B, Jacobs M, Nystrom P, Quinn R, Adams PJ, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy PM, Coyle C, Grizzard E, Garay S, Crowe RP, Lurie KG, Debaty GP, Labarere J. Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival. Resuscitation. 2022 Oct;179:9-17. doi: 10.1016/j.resuscitation.2022.07.039. Epub 2022 Aug 4.

  PMID: 35933057 BACKGROUND

• Tang W, Weil MH, Noc M, Sun S, Gazmuri RJ, Bisera J. Augmented efficacy of external CPR by intermittent occlusion of the ascending aorta. Circulation. 1993 Oct;88(4 Pt 1):1916-21. doi: 10.1161/01.cir.88.4.1916.

  PMID: 8403337 BACKGROUND

• Sesma J, Labandeira J, Sara MJ, Espila JL, Arteche A, Saez MJ. Effect of intra-aortic occlusion balloon in external thoracic compressions during CPR in pigs. Am J Emerg Med. 2002 Sep;20(5):453-62. doi: 10.1053/ajem.2002.32627.

  PMID: 12216044 BACKGROUND

• Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.

  PMID: 28117180 BACKGROUND

• Olsen MH, Olesen ND, Karlsson M, Holmlov T, Sondergaard L, Boutelle M, Mathiesen T, Moller K. Randomized blinded trial of automated REBOA during CPR in a porcine model of cardiac arrest. Resuscitation. 2021 Mar;160:39-48. doi: 10.1016/j.resuscitation.2021.01.010. Epub 2021 Jan 19.

  PMID: 33482264 BACKGROUND

• Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. 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. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742.

  PMID: 35160193 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Guillaume Pr Debaty, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandzo Aida

CONTACT

0476766816; amandzo@chu-grenoble.fr

Johanna Boeuf, MSc

CONTACT

0476634256; jboeuf1@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 5, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (1)