Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest With Successful Resuscitation
• Intervention / Treatment: Device: IQool

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15216
      • UPMC Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study participants will be cardiac arrest patients that have been successfully resuscitated.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1 cohort; Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.	Device: IQool; Subjects will undergo hypothermia therapy with the IQool system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Adam Frisch
• Collaborators: BrainCool
• Investigators: Principal Investigator: Jon Rittenberger, MD, Associate Professor of Emergency Medicine, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cardiac arrest; resuscitation; coma
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: PRO18060375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No