Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion

Cardiac Arrest Clinical Trial

— REVAMP  

Official title:

The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703453
• Other study ID #: 2000023899
• Status: Completed
• Phase: Early Phase 1
• Start date: January 28, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Time from first needle stick to sheath insertion	Procedural	Time of micropuncture needle first insertion into common femoral artery until successful 7 French (Fr) sheath insertion into common femoral artery
Secondary	Time from first needle stick to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) balloon inflation	Procedural	Time when micropuncture needle first insertion into common femoral artery until REBOA catheter balloon successfully inflated with 8 cc saline
Secondary	Number of needle sticks required for sheath insertion	Procedural	Time from first micropuncture needle stick until successful insertion of 7 Fr sheath into common femoral artery up to 30 minutes
Secondary	Change in systolic blood pressure after aortic occlusion	Hemodynamic	1 minutes before and 15 minutes after aortic occlusion
Secondary	Change in diastolic blood pressure after aortic occlusion	Hemodynamic	1 minute before and 15 minutes after aortic occlusion
Secondary	Change in end tidal carbon dioxide after aortic occlusion	Hemodynamics	1 minute before and 15 minutes after aortic occlusion
Secondary	Change in oxygen saturation from pulse oximeter	Hemodynamics	1 minute before and 15 minutes after aortic occlusion
Secondary	Change in coronary perfusion pressure	Hemodynamics	1 minute before and 15 minutes after aortic occlusion
Secondary	Change in Electrocardiogram (ECG) patterns	Hemodynamics	1 minute before and 15 minutes after aortic occlusion
Secondary	Neurologic function at 30 and 90 days	Measured by Modified Rankin Scale (mRS) and Cerebral Performance Category (CPC).; The mRS can help users determine the degree of disability in patients who have suffered a stroke or other causes of neurological disability by measuring the degree of disability or dependence in the daily activities of people. An mRS of a patient is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death. The mRS has been used in clinical research for over 30 years and is a common standard for assessing functional outcomes in patients. Multiple studies have shown that the mRS correlates with physiological indicators for neurological impairment.; The CPC score is the most commonly used tool to assess this for both research and audit purposes. Most studies define a good outcome as a CPC score of 1 or 2, and a poor outcome (severe neurological disability, persistent vegetative state or	30 and 90 days post enrollment
Secondary	Rate of return of spontaneous circulation (ROSC)	Patient Oriented	Arrival in ED to sustained ROSC or death, assessed up to 1 hour
Secondary	Rate of Intensive Care Unit (ICU) Admission	Patient Oriented	Death in ED or admission to ICU post sustained ROSC, assessed up to 24 hours
Secondary	Length of stay in ICU and total length of hospitalization	Patient Oriented	Time of admission in ICU to discharge or death, assessed up to 90 days