CompletedNot Applicable

Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

United States38 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of hypothermia induction

Timeframe: Up to 12 hours

Maintenance of hypothermia

Timeframe: 24 hours

Rewarming rate

Timeframe: Up to16 hours

Trial details

NCT IDNCT03889340

SponsorAdam Frisch

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Cardiac Arrest With Successful Resuscitation trials