Clinical trial NCT03534011: Resuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
Official title: Resuscitative Balloon Occlusion of the Aorta (REBOA) in Non-traumatic Out of Hospital Cardiac Arrest - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: Balloon occlusion
Air ambulances
Aorta
Resuscitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Air Ambulance Foundation
First posted: 2018-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: 20 minutes
measure: Complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Trondheim area
Study officials:
affiliation: St. Olavs Hospital
name: Sindre Mellesmo, md
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Jostein Rødseth Brede, md
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.