Cardiac ArrestCC-POCANCT05326789
Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study
A study testing REBOA catheter in people with Cardiac Arrest, run by Ciusss de L'Est de l'Île de Montréal.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- REBOA catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- REBOA catheter
- Keywords
- REBOA, ROSC, Cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOA catheterDevice
Also called resuscitative endovascular balloon occlusion of the aorta
balloon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: REBOA catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
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)
Measured: 0-15 min per study over a year
ETCO2
(Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min)
Measured: 0-15 min per study over a year
cerebral saturation
(Pre balloon occlusion, Post balloon occlusion 30sec, 1min, 5min, 10min, 15min)
Measured: 0-15 min per study over a year
ROSC
return of spontaneous circulation
Measured: 0-30 min per study over a year
TEE-guided REBOA positioning
success rate of determining REBOA placement by trans esophageal echocardiography
Measured: 5 minutes per study over 1 year
7 day survival
follow up to 7 days
Measured: 7 days over a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, single-arm, open (unblinded), feasibility, experimental study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326789
- Sponsor's protocol ID
- 2022-2677
- Acronym
- CC-POCA
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study
- ClinicalTrials.gov ID
- NCT05326789
- Acronym / sponsor ID
- CC-POCA / 2022-2677
- Conditions
- Cardiac Arrest
- Keywords
- REBOA, ROSC, Cardiac arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, single-arm, open (unblinded), feasibility, experimental study
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Device: REBOA catheter20 patients with inclusion criteria and without exclusion criteria will be entered in the interventional arm attempting to use REBOA during non-traumatic cardiac arrest. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Patients aged 18-75 years old
- Suspected reversible cause of cardiac arrest (except for trauma), with one of any of the following prognostic signs30
- 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
Key exclusion criteria (13 listed)
- Transfer accepted for ECPR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REBOA catheterAlso: resuscitative endovascular balloon occlusion of the aortaballoon occlusion of the aorta during cardiac arrest to optimize coronary and cerebral perfusion. | Device | interventional |
Primary outcome
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
6 secondary outcomes
blood pressure
Time frame: 0-15 min per study over a year
ETCO2
Time frame: 0-15 min per study over a year
cerebral saturation
Time frame: 0-15 min per study over a year
ROSC
Time frame: 0-30 min per study over a year
TEE-guided REBOA positioning
Time frame: 5 minutes per study over 1 year
7 day survival
Time frame: 7 days over a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA catheter in people with Cardiac Arrest, run by Ciusss de L'Est de l'Île de Montréal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Rola, MD (15142177892, philipperola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate and time of REBOA inflation during non-traumatic arrest in a community hospital (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.