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

Primary Purpose

Out-of-Hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Resuscitative Balloon Occlusion of the Aorta
REBOA catheter
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring Balloon occlusion, Air ambulances, Aorta, Resuscitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Trondheim area

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REBOA

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2018
Last Updated
December 17, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Air Ambulance Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03534011
Brief Title
Resuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
Acronym
REBOA
Official Title
Resuscitative Balloon Occlusion of the Aorta (REBOA) in Non-traumatic Out of Hospital Cardiac Arrest - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Air Ambulance Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS as described in the present guidelines from the Norwegian Resuscitation Council) 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. The ultrasound images will be stored and later processed by the principal investigator. If the physician experiences technical problems during the procedure (i.e. severe difficulties in establishing vascular access, resistance during insertion of the guidewire, introducer or balloon catheter, severe bleeding, prolonged time consumption) the effort will be aborted. If ROSC is achieved, the aortic balloon is deflated gently. If the patient re-enters cardiac arrest, the normal ACLS-guideline is followed. The balloon is then re-inflated, as described in the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Balloon occlusion, Air ambulances, Aorta, Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REBOA
Arm Type
Experimental
Arm Description
Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved
Intervention Type
Procedure
Intervention Name(s)
Resuscitative Balloon Occlusion of the Aorta
Other Intervention Name(s)
REBOA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
REBOA catheter
Intervention Description
Catheter with a Resuscitative Balloon for Occlusion of the Aorta
Primary Outcome Measure Information:
Title
Feasibility
Description
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)
Time Frame
20 minutes
Title
Complications
Description
Complications related to the REBOA procedure, immediate or late, as well as negative interaction on the cardiopulmonary resuscitation (CPR)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sindre Mellesmo, md
Organizational Affiliation
St Olavs Hospital University Hospital in Trondheim
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jostein Rødseth Brede, md
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trondheim area
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31076474
Citation
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.
Results Reference
background
PubMed Identifier
31707942
Citation
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.
Results Reference
background
PubMed Identifier
34911463
Citation
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.
Results Reference
result

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

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