Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion

NCT ID: NCT03703453

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2021-04-29

Brief Summary

REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flow to the distal aorta.

Study investigators hypothesize that this technique may be of use in the setting of medical cardiac arrest. By occluding the aorta and preventing distal blood flow during CPR, physicians might maximize perfusion to the heart and the brain, and promote return of spontaneous circulation and neurologic recovery.

Investigators plan to conduct an IDE approved early feasibility study using the ER-REBOA catheter in five patients who are in cardiac arrest of medical (i.e. non-traumatic) etiology. The primary outcomes will be feasibility and safety. Secondary outcomes will focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Investigators plan to expand the study to an additional 15 patients if, after the initial five patients, the risk-benefit profile remains favorable.

Detailed Description

The proposed study will assess the safety, feasibility, and efficacy of the use of the ER-REBOA™ catheter as a means of increasing cardio-cerebral perfusion in medical cardiac arrest patients. The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).

Dr. Daley (along with previous investigators) has hypothesized that by using the device to occlude distal blood flow during medical cardiac arrest, one might increase the perfusion to the brain and heart, maximizing the patient's chance for cardiac and neurologic recovery. Aortic occlusion for medical cardiac arrest is supported by robust pre-clinical literature, but has not yet been studied in humans.

The proposed study is divided into two phases, with a different primary outcome in each phase. Phase 1 of the study is expected to occur over a period of 1 year. Phase 2 expected duration is 1.5 years. Each phase of the study will require separate FDA/IRB approval. Enrollment will take place at Yale-New Haven Hospital in New Haven, CT, the primary site for Phase 1 and Phase 2 of the study. A potential secondary site, the University of California, Davis, has been approved for trial participation but will not contribute to enrollment during Phase 1.

Phase 1 will primarily examine the feasibility and safety of the use of the ER-REBOA catheter in five non-traumatic cardiac arrest patients. If deemed feasible and safe, the PI will request permission from the FDA and the IRB to expand the study to Phase 2. Phase 2 will consist of the enrollment of a subsequent 15 patients (20 in total for both phase 1 and 2) with a primary focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Per our hypothesis, if the ER-REBOA catheter is efficacious in medical cardiac arrest patients, an increase in systolic and diastolic blood pressure should be evident after the inflation of the intra-aortic balloon. Phase 2 will utilize the built in continuous arterial blood pressure monitoring capabilities of the device to assess for a significant blood pressure increase after the deployment of the aortic balloon.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REBOA

Patients undergoing REBOA for medical cardiac arrest

Group Type: EXPERIMENTAL

ER-REBOA catheter

Intervention Type: DEVICE

The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).

Interventions

ER-REBOA catheter

The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient must have had a witnessed cardiac arrest2 of suspected medical etiology
• CPR initiation within approximately 6 minutes of collapse (as estimated based on history provided by EMS), either by EMS, hospital personnel, or a bystander

Exclusion Criteria

• Known active terminal illness or severe dementia
• Known aortic disease
• Age 80 or older
• Total resuscitation time greater than approximately 45 minutes (from start of CPR)
• Age less than 18
• Wards of the state
• Known or suspected (by physical exam or history) pregnancy
• Suspected traumatic cause of cardiac arrest
• Known Do Not Resuscitate (DNR) orders
• Anticipated difficult procedure (e.g. signs of peripheral vascular disease, severe obesity, or otherwise deemed likely to be difficult by enrollment staff)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

James I. Daley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.

Reference Type: BACKGROUND

PMID: 28117180 (View on PubMed)

Other Identifiers

2000023899

Identifier Type: -

Identifier Source: org_study_id