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

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: Cardiac Arrest
• Intervention / Treatment: Device: REBOA catheter

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

• Study Contact: Name: Philippe Rola, MD; Phone Number: 15142177892; Email: philipperola@gmail.com
• Study Contact Backup: Name: Lawrence Leroux, MD; Phone Number: 15148894644; Email: lawrence.leroux.1@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	● 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

Collaborators and Investigators

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

Study record dates

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: Cardiac arrest; ROSC; REBOA
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• 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