Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Cardiac Arrest With Successful Resuscitation Clinical Trial

Official title:

Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889340
• Other study ID #: PRO18060375
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 1, 2021
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest With Successful Resuscitation
• Heart Arrest

Intervention

Device:
• IQool
Subjects will undergo hypothermia therapy with the IQool system

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Adam Frisch	BrainCool

Country where clinical trial is conducted

United States, 

Outcome

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