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

NCT03534011 | Completed

• 1 other identifier: 2018/51
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Balloon occlusion; Air ambulances; Aorta; Resuscitation

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Report of the feasibility is based on the ease of performing the REBOA procedure. A checklist which grades the different technical moments and time consumption of the procedure is described in a separate document. All physicians will be interviewed by the principal investigator to assess other factors that influenced the in-field performance of the procedure (i.e weather, temperature, light condition, body habitus, constrained room)

  20 minutes

• Complications

  Complications related to the REBOA procedure, immediate or late, as well as negative interaction on the cardiopulmonary resuscitation (CPR)

  30 days

Study Arms (1)

REBOA

EXPERIMENTAL

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

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

Interventions

Resuscitative Balloon Occlusion of the Aorta PROCEDURE

If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS) 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.

Also known as: REBOA

REBOA

REBOA catheter DEVICE

Catheter with a Resuscitative Balloon for Occlusion of the Aorta

REBOA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Norwegian Air Ambulance Foundation: collaborator

Study Sites (1)

Trondheim area

Trondheim, Norway

Location

Related Publications (3)

• Brede JR, Lafrenz T, Kruger AJ, Sovik E, Steffensen T, Kriesi C, Steinert M, Klepstad P. Resuscitative endovascular balloon occlusion of the aorta (REBOA) in non-traumatic out-of-hospital cardiac arrest: evaluation of an educational programme. BMJ Open. 2019 May 9;9(5):e027980. doi: 10.1136/bmjopen-2018-027980.

  PMID: 31076474 BACKGROUND

• Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.

  PMID: 31707942 BACKGROUND

• Brede JR, Skjaerseth E, Klepstad P, Nordseth T, Kruger AJ. Changes in peripheral arterial blood pressure after resuscitative endovascular balloon occlusion of the aorta (REBOA) in non-traumatic cardiac arrest patients. BMC Emerg Med. 2021 Dec 15;21(1):157. doi: 10.1186/s12873-021-00551-y.

  PMID: 34911463 RESULT

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sindre Mellesmo, md

  St. Olavs Hospital

  STUDY DIRECTOR

• Jostein Rødseth Brede, md

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 23, 2018
• Study Start: June 15, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

NO (1)