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Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889340
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
BrainCool
Information provided by (Responsible Party):
Adam Frisch, University of Pittsburgh

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.

Condition or disease Intervention/treatment
Cardiac Arrest With Successful Resuscitation Device: IQool

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
Phase 1 cohort
Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.
Device: IQool
Subjects will undergo hypothermia therapy with the IQool system




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Study participants will be cardiac arrest patients that have been successfully resuscitated.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889340


Contacts
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Contact: Jon C Rittenberger, MD 412-647-9489 rittjc@upmc.edu
Contact: Sara DiFiore 412-864-2284 difioresm@upmc.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15216
Contact: Jon C Rittenberger, MD    412-864-2284    rittjc@upmc.edu   
Contact: Sara DiFiore    412-864-2284    difioresm@upmc.edu   
Sponsors and Collaborators
Adam Frisch
BrainCool
Investigators
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Principal Investigator: Jon Rittenberger, MD Associate Professor of Emergency Medicine, University of Pittsburgh
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Responsible Party: Adam Frisch, Assistant Professor of Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03889340    
Other Study ID Numbers: PRO18060375
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Adam Frisch, University of Pittsburgh:
resuscitation
cardiac arrest
coma
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases