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

Cardiac Arrest Clinical Trial

— CC-POCA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05326789
• Other study ID #: 2022-2677
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2022
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Philippe Rola, MD
• Phone: 15142177892
• Email: philipperola[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• REBOA catheter
balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Outcome

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