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Carbon Monoxide PoisoningNCT04975867

Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

A study testing Targeted therapeutic hypothermia and Targeted therapeutic normothermia in people with Carbon Monoxide Poisoning and Neurologic Sequelae, run by Wonju Severance Christian Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized trial will investigate important neurocognitive clinical outcomes of patients with acute severe carbon monoxide poisoning (ASCOP) randomized to receive either therapeutic hypothermia or normothermia combined with hyperbaric oxygen therapy (HBO). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Targeted therapeutic hypothermia and Targeted therapeutic normothermia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesSouth Korea
Study dates
25 Oct 2021to 7 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Inha University Hospital

    Incheon, Incheon, 22332

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

About this study

Official title: Targeted Temperature Management Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning: Multicenter Randomized Controlled Clinical Trial (TTM-COHB Trial)

This randomized trial will investigate important neurocognitive clinical outcomes of patients with acute severe carbon monoxide poisoning (ASCOP) randomized to receive either therapeutic hypothermia or normothermia combined with hyperbaric oxygen therapy (HBO).

Read the detailed description

CO-poisoned patients are identified by medical history and carboxyhemoglobin (CO-Hb) value >5% (>10% in smokers). Patients presenting with acute CO poisoning will receive one HBO. ASCOP is defined as mental status showing response to painful stimulus or unresponsiveness requiring intubation for airway protection and ventilation support at the emerency department, and persistence of depressed mental status despite the HBO. After HBO treatment, eligible patients who provide consent will be randomly allocated to receive hypothermia, or normothermia treatment administered in a open label fashion except for blinding of outcome assessor.

Outcome measures will be administered at 1 month and 6 months after CO exposure. In addition, we will examine the differences in serum markers and mortality between the hypothermia and normothermia groups.

Being tested
Targeted therapeutic hypothermia, Targeted therapeutic normothermia
Medical subject headings
Carbon Monoxide Poisoning, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted therapeutic hypothermiaOther

    Targeted therapeutic hypothermia is then performed at a body temperature of 33±0.5 °C during 24 h using a surface cooling device as soon as possible after the HBO and research consent. After TH ended, rewarming is done slowly between 0.2℃ - 0.5℃/h for 12 hours. After rewarming, it will be held at 36.5 ℃ for 36 hours.

  • Targeted therapeutic normothermiaOther

    Targeted therapeutic normothermia will be held at 36.5±0.5 ℃ for 72 hours using a surface cooling device after the HBO and research consent.

Study groups in NCT04975867
Study groupRoleWhat they receive
Hypothermia groupExperimentalHypothermia group is then performed at a body temperature of 33±0.5 °C during 24 h using a surface cooling device as soon as possible after the HBO and research consent. After therapeutic hypothermia ended, rewarming is done slowly between 0.2℃ - 0.5℃/h for 12 hours. After rewarming, it will be held at 36.5 ℃ for 36 hours.
Receives: Other: Targeted therapeutic hypothermia
Normothermia groupActive comparatorFor normothermia group, it will be held at 36.5±0.5 ℃ for 72 hours using a surface cooling device after the HBO and research consent.
Receives: Other: Targeted therapeutic normothermia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main neurocognitive outcome

    Global Deterioration Scale [range 1 - 7 (worst score)]

    Measured: At 6 months after CO poisoning

Secondary outcomes (37)

  1. Neurocognitive outcome

    Global Deterioration Scale [range 1 - 7 (worst score)]

    Measured: At 1 month after CO poisoning

  2. Cerebral Performance Category

    Cerebral Performance Category [range 1 - 5 (worst score)]

    Measured: At 1 month and 6 months after CO poisoning

  3. modified Rankin scale

    modified Rankin scale [range 0 - 6 (worst score)]

    Measured: At 1 month and 6 months after CO poisoning

  4. Glasgow outcome scale

    Glasgow outcome scale [range 1 (worst score) - 5]

    Measured: At 1 month and 6 months after CO poisoning

  5. mini-mental status exam

    mini-mental status exam

    Measured: At 1 month and 6 months after CO poisoning

  6. Korean version of the Modified Barthel Index

    Korean version of the Modified Barthel Index

    Measured: At 1 month and 6 months after CO poisoning

  7. Mortality in intensive care unit

    Number of participants with mortality in intensive care unit

    Measured: Through study completion, an average of 6 months

  8. Mortality in intensive care unit

    Rate of participants with mortality in intensive care unit

    Measured: Through study completion, an average of 6 months

  9. In-hospital mortality

    Number of participants with in-hospital mortality

    Measured: Through study completion, an average of 6 months

  10. In-hospital mortality

    Rate of participants with in-hospital mortality

    Measured: Through study completion, an average of 6 months

  11. Mortality

    Number of participants with all cause mortality

    Measured: At 1, 3, and 6 months after CO poisoning

  12. Mortality

    Rate of participants with all cause mortality

    Measured: At 1, 3, and 6 months after CO poisoning

  13. Length of stay in intensive care unit and hospital

    Length of stay in intensive care unit and hospital

    Measured: Through study completion, an average of 6 months

  14. Pneumonia

    Number of participants with the diagnosis of pneumonia. Diagnosis is established when the following two criteria are met: 1) the appearance of a new infiltrate or consolidation on chest x-ray; and 2) leukocytosis, or leukopenia, or the significant presence of meaningful bacteria in a sputum culture with the absence of other infections.

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  15. Pneumonia

    Rate of participants with the diagnosis of pneumonia. Diagnosis is established when the following two criteria are met: 1) the appearance of a new infiltrate or consolidation on chest x-ray; and 2) leukocytosis, or leukopenia, or the significant presence of meaningful bacteria in a sputum culture with the absence of other infections.

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  16. Shock

    Number of participants with shock. Diagnosis is diagnosed when a vasopressor is needed to resuscitate the patient and lactate levels exceeded 2.0 mmol/L.

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  17. Shock

    Rate of participants with shock. Diagnosis is diagnosed when a vasopressor is needed to resuscitate the patient and lactate levels exceeded 2.0 mmol/L.

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  18. Bradycardia

    Number of participants with dropped heart rate indicated drug or interventions

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  19. Bradycardia

    Rate of participants with dropped heart rate indicated drug or interventions

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  20. Hypokalemia

    Number of participants with serum K concentration <3.0 - 2.5 mmol/L

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  21. Hypokalemia

    Rate of participants with serum K concentration <3.0 - 2.5 mmol/L

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  22. Hyperkalemia

    Number of participants with serum K concentration >6.0 - 7.0 mmol/L

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  23. Hyperkalemia

    Rate of participants with serum K concentration >6.0 - 7.0 mmol/L

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  24. Hyperglycemia

    Number of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  25. Hyperglycemia

    Rate of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  26. Hypophosphatemia

    Number of participants with a disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood and indicated replacement therapy

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  27. Hypophosphatemia

    Rate of participants with a disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood and indicated replacement therapy

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  28. Hypomagnesemia

    Number of participants with serum magnesium <0.9 - 0.7 mg/dL

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  29. Hypomagnesemia

    Rate of participants with serum magnesium <0.9 - 0.7 mg/dL

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  30. Prolonged prothrombin Time International Normalized Ratio

    Number of participants with >2.5 x upper limit of the normal range and bleeding

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  31. Prolonged prothrombin Time International Normalized Ratio

    Rate of participants with >2.5 x upper limit of the normal range and bleeding

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  32. Prolonged activated partial thromboplastin time

    Number of participants with >2.5 x upper limit of the normal range and bleeding

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  33. Prolonged activated partial thromboplastin time

    Rate of participants with >2.5 x upper limit of the normal range and bleeding

    Measured: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)

  34. S100ß (serum)

    Concentration of S100ß (serum)

    Measured: Within 14 days after CO exposure

  35. Neuronal specific enolase (serum)

    Concentration of neuronal specific enolase (serum)

    Measured: Within 14 days after CO exposure

  36. Brain magnetic resonance image (MRI)

    Number of participants with brain injury in brain MRI

    Measured: Within 14 days after CO exposure

  37. Brain magnetic resonance image (MRI)

    Rate of participants with brain injury in brain MRI

    Measured: Within 14 days after CO exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2021
  2. Study start25 Oct 2021
  3. Primary completion7 Nov 2025
  4. Study completion7 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975867
Sponsor's protocol ID
TTM-COHB trial
Other IDs
CR220011, 2021-04-043
Status last verified
Jun 2025
First submitted
1 Jul 2021
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim SJ, Thom SR, Kim H, Hwang SO, Lee Y, Park EJ, Lee SJ, Cha YS. Effects of Adjunctive Therapeutic Hypothermia Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning. Crit Care Med. 2020 Aug;48(8):e706-e714. doi: 10.1097/CCM.0000000000004419.

    PubMed 32697512

Questions about this trial

What is this clinical trial studying?

A study testing Targeted therapeutic hypothermia and Targeted therapeutic normothermia in people with Carbon Monoxide Poisoning and Neurologic Sequelae, run by Wonju Severance Christian Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main neurocognitive outcome (time frame: At 6 months after CO poisoning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04975867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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