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

Out-of-Hospital Cardiac Arrest Clinical Trial

— REBOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534011
• Other study ID #: 2018/51
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• Resuscitative Balloon Occlusion of the Aorta
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.

Device:
• REBOA catheter
Catheter with a Resuscitative Balloon for Occlusion of the Aorta

Locations

Country	Name	City	State
Norway	Trondheim area	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Air Ambulance Foundation, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Brede JR, Lafrenz T, Klepstad P, Skjærseth EA, Nordseth T, Søvik E, Krüger 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. — View Citation

Brede JR, Lafrenz T, Krüger AJ, Søvik 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. — View Citation

Brede JR, Skjærseth E, Klepstad P, Nordseth T, Krüger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complications	Complications related to the REBOA procedure, immediate or late, as well as negative interaction on the cardiopulmonary resuscitation (CPR)	30 days