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OpenTrials
Completed

NCT Number: NCT03889340

Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15216, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IQool

Device

Subjects will undergo hypothermia therapy with the IQool system

Primary outcomes

  1. Rate of hypothermia induction

    Time frame: Up to 12 hours

    Induction of hypothermia will occur at a rate of at least 1C/hr

  2. Maintenance of hypothermia

    Time frame: 24 hours

    The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase

  3. Rewarming rate

    Time frame: Up to16 hours

    When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming

Secondary outcomes

  1. Number of physicians that recommend the IQool system for temperature management

    Time frame: 72 hours

    Clinicians will be asked if they agree that the IQool system provides effective temperature management >90% of the time

Sponsors and collaborators

Lead sponsor

Adam Frisch

Other

Collaborators

  • BrainCool

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2019
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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