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

NCT ID: NCT05326789

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-08-01

Brief Summary

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

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

Conditions

Cardiac Arrest

Study Design

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

Study Groups

interventional

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.

Group Type: EXPERIMENTAL

REBOA catheter

Intervention Type: DEVICE

balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.

Interventions

REBOA catheter

balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.

Intervention Type: DEVICE

Other Intervention Names

resuscitative endovascular balloon occlusion of the aorta

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Philippe Rola, MD

Role: CONTACT

philipperola@gmail.com

15142177892

Lawrence Leroux, MD

Role: CONTACT

lawrence.leroux.1@gmail.com

15148894644

Other Identifiers

2022-2677

Identifier Type: -

Identifier Source: org_study_id