Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Study Overview
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Brief Summary
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This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.

Detailed Description
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Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed. The following phases will be conducted as standard of care, and will be reviewed for this study: Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature). Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range. Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control. Post TTM fever control: The subject will be kept at a body temperature of 37°C until 72 hours after the cardiac arrest or earlier if the subject regains consciousness.

Official Title
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Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Conditions
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Cardiac Arrest With Successful Resuscitation

Intervention / Treatment
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* Device: IQool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In- or out-of-hospital cardiac arrest of all initial rhythms Adult patients (18 years of age and older) Unconscious on admission to hospital, defined as not following commands Indication for targeted temperature management Exclusion Criteria: Pregnancy Prisoner Active do not resuscitate order Any patient not expected to survive 72 hours Skin infection Skin wound affecting site of temperature exchange pads

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1 cohort<br>Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device. | Device: IQool<br>* Subjects will undergo hypothermia therapy with the IQool system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypothermia induction | Induction of hypothermia will occur at a rate of at least 1C/hr | Up to 12 hours | 
| Maintenance of hypothermia | The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase | 24 hours | 
| Rewarming rate | When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming | Up to16 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physicians that recommend the IQool system for temperature management | Clinicians will be asked if they agree that the IQool system provides effective temperature management >90% of the time | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resuscitation, cardiac arrest, coma