Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study (CC-POCA)

April 6, 2022 updated by: Ciusss de L'Est de l'Île de Montréal
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: REBOA catheter
balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.
Other Names:
  • resuscitative endovascular balloon occlusion of the aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate and time of REBOA inflation during non-traumatic arrest in a community hospital
Time Frame: 1 year
● 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
Time Frame: 0-15 min per study over a year
  • 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
Time Frame: 0-15 min per study over a year
(Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min)
0-15 min per study over a year
cerebral saturation
Time Frame: 0-15 min per study over a year
(Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min)
0-15 min per study over a year
ROSC
Time Frame: 0-30 min per study over a year
return of spontaneous circulation
0-30 min per study over a year
TEE-guided REBOA positioning
Time Frame: 5 minutes per study over 1 year
success rate of determining REBOA placement by trans esophageal echocardiography
5 minutes per study over 1 year
7 day survival
Time Frame: 7 days over a year
follow up to 7 days
7 days over a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (ACTUAL)

April 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-2677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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