Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

NCT ID: NCT03889340

Last Updated: 2021-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-12-01

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Phase 1 cohort

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

IQool

Intervention Type: DEVICE

Subjects will undergo hypothermia therapy with the IQool system

Interventions

IQool

Subjects will undergo hypothermia therapy with the IQool system

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainCool

UNKNOWN

Sponsor Role: collaborator

Adam Frisch

OTHER

Sponsor Role: lead

Responsible Party

Adam Frisch

Assistant Professor of Emergency Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jon Rittenberger, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Emergency Medicine, University of Pittsburgh

Locations

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO18060375

Identifier Type: -

Identifier Source: org_study_id