Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Completed

• Conditions: Cardiac Arrest With Successful Resuscitation
• Interventions: Device: IQool

• Registration Number: NCT03889340
• Lead Sponsor: Adam Frisch

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-26
• Study Start: 2019-05-01
• Primary Completion: 2021-05-31
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 1 cohort	IQool	Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of physicians that recommend the IQool system for temperature management	72 hours	Clinicians will be asked if they agree that the IQool system provides effective temperature management \>90% of the time

Trial Locations

Locations (1)

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States