Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Adam Frisch

Status: Completed

Conditions: Cardiac Arrest With Successful Resuscitation

Treatments: Device: IQool

Study type: Observational

Funder types: Other

Identifiers

NCT03889340

PRO18060375

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Phase 1 cohort

Description:

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

Treatment:

Device: IQool