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

NCT05326789 | Unknown DMC

• 1 other identifier: 2022-2677
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest

Keywords

REBOA; ROSC; Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• blood pressure

  0-15 min per study over a year

• ETCO2

  0-15 min per study over a year

• cerebral saturation

  0-15 min per study over a year

• ROSC

  0-30 min per study over a year

• TEE-guided REBOA positioning

  5 minutes per study over 1 year

Study Arms (1)

interventional

EXPERIMENTAL

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

Interventions

REBOA catheter DEVICE

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

Also known as: resuscitative endovascular balloon occlusion of the aorta

interventional

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Philippe Rola, MD

CONTACT

15142177892; philipperola@gmail.com

Lawrence Leroux, MD

CONTACT

15148894644; lawrence.leroux.1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, single-arm, open (unblinded), feasibility, experimental study

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04