Out-of-Hospital Cardiac Arrest Clinical Trial
— REBOAOfficial title:
Resuscitative Balloon Occlusion of the Aorta (REBOA) in Non-traumatic Out of Hospital Cardiac Arrest - a Pilot Study
NCT number | NCT03534011 |
Other study ID # | 2018/51 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | March 31, 2021 |
Verified date | December 2021 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Trondheim area | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Norwegian Air Ambulance Foundation, St. Olavs Hospital |
Norway,
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
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 |
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