NCT03889340

Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Adam Frisch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Cardiac Arrest With Successful Resuscitation

Interventions

Type	Name	Description
DEVICE	IQool	Subjects will undergo hypothermia therapy with the IQool system

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-05-31
• Completion: 2021-12-01
• First posted: 2019-03-26
• Last updated: 2021-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study