Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Sponsors

Lead sponsor: Adam Frisch

Collaborator: BrainCool

Source University of Pittsburgh
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.

Overall Status Recruiting
Start Date May 1, 2019
Completion Date October 31, 2020
Primary Completion Date May 31, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Rate of hypothermia induction Up to 12 hours
Maintenance of hypothermia 24 hours
Rewarming rate Up to16 hours
Secondary Outcome
Measure Time Frame
Number of physicians that recommend the IQool system for temperature management 72 hours
Enrollment 40
Condition
Intervention

Intervention type: Device

Intervention name: IQool

Description: Subjects will undergo hypothermia therapy with the IQool system

Arm group label: Phase 1 cohort

Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Overall Official
Last Name Role Affiliation
Jon Rittenberger, MD Principal Investigator Associate Professor of Emergency Medicine, University of Pittsburgh
Overall Contact

Last name: Jon C Rittenberger, MD

Phone: 412-647-9489

Email: [email protected]

Location
facility status contact contact_backup
UPMC Presbyterian Hospital Recruiting Jon C Rittenberger, MD 412-864-2284 [email protected]
Location Countries

United States

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of Pittsburgh

Investigator full name: Adam Frisch

Investigator title: Assistant Professor of Emergency Medicine

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Phase 1 cohort

Description: Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov