Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

NCT03889340 | Completed FDA Device

• 1 other identifier: PRO18060375
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Keywords

resuscitation; cardiac arrest; coma

Outcome Measures

Primary Outcomes (3)

• Rate of hypothermia induction

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

  Up to 12 hours

• Maintenance of hypothermia

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

  24 hours

• Rewarming rate

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

  Up to16 hours

Secondary Outcomes (1)

• Number of physicians that recommend the IQool system for temperature management

  72 hours

Study Arms (1)

Phase 1 cohort

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

Device: IQool

Interventions

IQool DEVICE

Subjects will undergo hypothermia therapy with the IQool system

Phase 1 cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be cardiac arrest patients that have been successfully resuscitated.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adam Frisch: lead
• BrainCool: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15216, United States

Location

MeSH Terms

Conditions

Heart Arrest; Coma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Rittenberger, MD

  Associate Professor of Emergency Medicine, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 26, 2019
• Study Start: May 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (1)