Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT03889340|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment|
|Cardiac Arrest With Successful Resuscitation||Device: IQool|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
Phase 1 cohort
Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.
Subjects will undergo hypothermia therapy with the IQool system
- Rate of hypothermia induction [ Time Frame: Up to 12 hours ]Induction of hypothermia will occur at a rate of at least 1C/hr
- Maintenance of hypothermia [ Time Frame: 24 hours ]The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase
- Rewarming rate [ Time Frame: Up to16 hours ]When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming
- Number of physicians that recommend the IQool system for temperature management [ Time Frame: 72 hours ]Clinicians will be asked if they agree that the IQool system provides effective temperature management >90% of the time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889340
|Contact: Jon C Rittenberger, MDfirstname.lastname@example.org|
|Contact: Sara DiFioreemail@example.com|
|Principal Investigator:||Jon Rittenberger, MD||Associate Professor of Emergency Medicine, University of Pittsburgh|