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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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