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Cooling therapy may shield brain after CO poisoning

NCT ID NCT04975867

Disease control Sponsor: Wonju Severance Christian Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether cooling the body to 33°C for 24 hours, combined with hyperbaric oxygen therapy, improves brain recovery in adults with severe carbon monoxide poisoning. 37 participants were randomly assigned to either therapeutic hypothermia or normothermia (keeping body temperature normal). The goal was to see if cooling reduces long-term neurological damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
targeted temperature management (therapeutic hypothermia or normothermia) combined with hyperbaric oxygen therapy
What this could lead to
If it works, this could point toward a better way to prevent long-term brain damage after severe carbon monoxide poisoning.
What could go wrong
This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. The treatment involves cooling the body, which carries risks like infection or heart issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥ 19 years. * Patients who received HBO within 24 hours for acute CO poisoning. * Patients who meet the definition of ASCOP (Patients incapable verbal obey after HBO). * Signed informed consent prior to study entry. Exclusion Criteria: * Cardiac arrest before HBO * Previous neurocognitive disorders * Life-threatening underlying disease (ex: advanced cancer) * Evidence of co-ingestion of sedative or hypnotics confirmed by intravenous flumazenil administration or history taking at the emergency department * Absolute contraindication for TH (active severe bleeding and profound shock not controlled by vasoactive drugs) * No admission * The significant co-ingested drug levels, which are alter the consciousness, is confirmed from the drug analysis lab * Pregnancy * Burns * More than moderate burn or Inhalation burn * Burns complicated by other trauma * Electrical burn * Burns in high risk patients (Patients with chronic underlying diseases (i.e DM, ESRD, liver cirrhosis, etc) which may cause delays or aggravate the wound healing)

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Conditions

The condition(s) this trial relates to.

carbon monoxide poisoning Hypothermia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carbon monoxide poisoning Hypothermia Neurologic sequelae

Contacts and locations

Locations

  • Inha University Hospital

    Incheon, Incheon, 22332, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426, South Korea

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