Clinical trial NCT03703453: Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiac Arrest
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: REBOA in medical cardiac arrest patients
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of aortic occlusion
timeFrame: The time expected for the procedure typically take between 10 and 15 minutes.
measure: Safety of Procedure
timeFrame: Time of procedure to 90-days post-discharge
Secondary outcomes:
measure: Time from first needle stick to sheath insertion
timeFrame: Time of micropuncture needle first insertion into common femoral artery until successful 7 French (Fr) sheath insertion into common femoral artery
measure: Time from first needle stick to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) balloon inflation
timeFrame: Time when micropuncture needle first insertion into common femoral artery until REBOA catheter balloon successfully inflated with 8 cc saline
measure: Number of needle sticks required for sheath insertion
timeFrame: Time from first micropuncture needle stick until successful insertion of 7 Fr sheath into common femoral artery up to 30 minutes
measure: Change in systolic blood pressure after aortic occlusion
timeFrame: 1 minutes before and 15 minutes after aortic occlusion
measure: Change in diastolic blood pressure after aortic occlusion
timeFrame: 1 minute before and 15 minutes after aortic occlusion
measure: Change in end tidal carbon dioxide after aortic occlusion
timeFrame: 1 minute before and 15 minutes after aortic occlusion
measure: Change in oxygen saturation from pulse oximeter
timeFrame: 1 minute before and 15 minutes after aortic occlusion
measure: Change in coronary perfusion pressure
timeFrame: 1 minute before and 15 minutes after aortic occlusion
measure: Change in Electrocardiogram (ECG) patterns
timeFrame: 1 minute before and 15 minutes after aortic occlusion
measure: Neurologic function at 30 and 90 days
timeFrame: 30 and 90 days post enrollment
measure: Rate of return of spontaneous circulation (ROSC)
timeFrame: Arrival in ED to sustained ROSC or death, assessed up to 1 hour
measure: Rate of Intensive Care Unit (ICU) Admission
timeFrame: Death in ED or admission to ICU post sustained ROSC, assessed up to 24 hours
measure: Length of stay in ICU and total length of hospitalization
timeFrame: Time of admission in ICU to discharge or death, assessed up to 90 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
citation: 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.