Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study

Study Overview
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Brief Summary
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Our general objective, during this study, is to evaluate the feasibility and potential physiological benefits of using REBOA (resuscitative endovascular balloon occlusion of the aorta) CPR (cardiopulmonary resuscitation) for patients presenting with a cardiac arrest to a community hospital. This would represent the first step for doing a larger, randomized clinical trial on the use of REBOA in non-traumatic cardiac arrest.

Detailed Description
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Primary objective: Validate the feasibility of using REBOA in a community hospital setting during cardiac arrest as an adjunct to ACLS (advances cardiac life support) . This will be done by measuring time to REBOA placement and successful inflation. Furthermore, we will also document any REBOA related complications. Secondary objectives: Evaluate the potential physiological benefits of REBOA for human subjects in NTCA (non traumatic cardiac arrest) that are not responding to standard ACLS. Study Design and Methodology Trial design The trial is a single-center, single-arm, open (unblinded), feasibility, experimental study. Study Duration The study is expected to begin in winter 2022 and last approximately 12 months. Population studied The population studied will be patients in non-traumatic cardiac arrest at Santa Cabrini Hospital, aged 18-75 years old. Patients presenting with a witnessed cardiac arrest (out of hospital cardiac arrest (OHCA) or in hospital cardiac arrest (IHCA)) and in which ACLS was performed for at least 15 minutes or BLS for at least 30 minutes and for no more than 60 minutes will be evaluated for eligibility to participate in the study. Number of patients 20

Official Title
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Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: REBOA catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients aged 18-75 years old Suspected reversible cause of cardiac arrest (except for trauma), with one of any of the following prognostic signs30 Reactive pupils Agonal breathing EtCO2>10 mmHg Any cardiac activity on bedside echocardiogram Body habitus accommodating automated Lund University Cardiac Arrest System (LUCAS) Level of care includes CPR, or unable to obtain level of care (if possible, validate with relative) More than 15 minutes of ACLS with no ROSC or more than 30 minutes of BLS with no ROSC Exclusion Criteria: Transfer accepted for ECPR History of severe dementia Advance Medical Directives against resuscitation History of aortic pathology or surgery LUCAS not compatible with the patient's body habitus Pregnancy Any illness resulting in loss of independent living capacity Severe cardiopulmonary disease Aortic dissection, aortic aneurysm, tension pneumothorax or tamponade seen on TEE/TTE Strangulation Suspected intracerebral hemorrhage Accidental hypothermia More than 60 minutes of resuscitation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-center, single-arm, open (unblinded), feasibility, experimental study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional<br>20 patients with inclusion criteria and without exclusion criteria will be entered in the interventional arm attempting to use REBOA during non-traumatic cardiac arrest. | Device: REBOA catheter<br>* balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.<br>* Other names: resuscitative endovascular balloon occlusion of the aorta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate and time of REBOA inflation during non-traumatic arrest in a community hospital | ● Feasibility of intra-arrest REBOA catheter placement and zone 1 inflation in NTCA in a community hospital setting | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | Systolic blood pressure (Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min) Diastolic blood pressure (Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min) | 0-15 min per study over a year | 
| ETCO2 | (Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min) | 0-15 min per study over a year | 
| cerebral saturation | (Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min) | 0-15 min per study over a year | 
| ROSC | return of spontaneous circulation | 0-30 min per study over a year | 
| TEE-guided REBOA positioning | success rate of determining REBOA placement by trans esophageal echocardiography | 5 minutes per study over 1 year | 
| 7 day survival | follow up to 7 days | 7 days over a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REBOA, ROSC, Cardiac arrest