Clinical trial NCT05326789: Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study
Official title: Coronary and Cerebral Perfusion Optimization in Cardiac Arrest: A Feasibility and Physiological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: REBOA
ROSC
Cardiac arrest
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, single-arm, open (unblinded), feasibility, experimental study
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: success rate and time of REBOA inflation during non-traumatic arrest in a community hospital
timeFrame: 1 year
Secondary outcomes:
measure: blood pressure
timeFrame: 0-15 min per study over a year
measure: ETCO2
timeFrame: 0-15 min per study over a year
measure: cerebral saturation
timeFrame: 0-15 min per study over a year
measure: ROSC
timeFrame: 0-30 min per study over a year
measure: TEE-guided REBOA positioning
timeFrame: 5 minutes per study over 1 year
measure: 7 day survival
timeFrame: 7 days over a year
Other outcomes:
Locations:
Study officials:
References: