Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion

NCT03703453 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: 2000023899
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

• Feasibility of aortic occlusion

  The successful inflation of the aortic balloon at the level of the diaphragm with resultant occlusion of aortic blood flow. The procedure will be considered feasible if aortic balloons are deployed at the level of the diaphragm in at least 70% of patients attempted. The location of the balloon will be confirmed with bedside ultrasound and/or X-ray. Successful aortic occlusion will be confirmed using flow measurements on bedside ultrasound as well as detecting a lack of blood pressure distal to the aortic balloon using a pressure transducer in the femoral artery.

  The time expected for the procedure typically take between 10 and 15 minutes.

• Safety of Procedure

  Safety is defined by a composite prevalence of five pre-specified adverse events. •Composite events: blood vessel damage requiring intervention, arterial thromboembolism, lower extremity amputation, renal failure requiring non-temporary dialysis, lower extremity paralysis

  Time of procedure to 90-days post-discharge

Secondary Outcomes (13)

• Time from first needle stick to sheath insertion

  Time of micropuncture needle first insertion into common femoral artery until successful 7 French (Fr) sheath insertion into common femoral artery

• Time from first needle stick to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) balloon inflation

  Time when micropuncture needle first insertion into common femoral artery until REBOA catheter balloon successfully inflated with 8 cc saline

• Number of needle sticks required for sheath insertion

  Time from first micropuncture needle stick until successful insertion of 7 Fr sheath into common femoral artery up to 30 minutes

• Change in systolic blood pressure after aortic occlusion

  1 minutes before and 15 minutes after aortic occlusion

• Change in diastolic blood pressure after aortic occlusion

  1 minute before and 15 minutes after aortic occlusion

Study Arms (1)

REBOA

EXPERIMENTAL

Patients undergoing REBOA for medical cardiac arrest

Device: ER-REBOA catheter

Interventions

ER-REBOA catheter 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).

REBOA

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 28117180 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: REBOA in medical cardiac arrest patients

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: January 28, 2020
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)