Clinical trial NCT03889340: Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
Official title: Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest With Successful Resuscitation
Keywords: resuscitation
cardiac arrest
coma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: BrainCool
First posted: 2019-03-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be cardiac arrest patients that have been successfully resuscitated.

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.

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

Primary outcomes:
measure: Rate of hypothermia induction
timeFrame: Up to 12 hours
measure: Maintenance of hypothermia
timeFrame: 24 hours
measure: Rewarming rate
timeFrame: Up to16 hours
Secondary outcomes:
measure: Number of physicians that recommend the IQool system for temperature management
timeFrame: 72 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: Associate Professor of Emergency Medicine, University of Pittsburgh
name: Jon Rittenberger, MD
role: PRINCIPAL_INVESTIGATOR
References: