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Completed

NCT Number: NCT04975867

Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

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).

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Key information

Conditions

Carbon Monoxide Poisoning Body Temperature Changes Chemically-Induced Disorders Gas Poisoning Hypothermia Neurologic Sequelae Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Targeted therapeutic hypothermia

Other

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 normothermia

Other

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.

Primary outcomes

  1. Main neurocognitive outcome

    Time frame: At 6 months after CO poisoning

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

Secondary outcomes

  1. Neurocognitive outcome

    Time frame: At 1 month after CO poisoning

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

  2. Cerebral Performance Category

    Time frame: At 1 month and 6 months after CO poisoning

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

  3. modified Rankin scale

    Time frame: At 1 month and 6 months after CO poisoning

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

  4. Glasgow outcome scale

    Time frame: At 1 month and 6 months after CO poisoning

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

  5. mini-mental status exam

    Time frame: At 1 month and 6 months after CO poisoning

    mini-mental status exam

  6. Korean version of the Modified Barthel Index

    Time frame: At 1 month and 6 months after CO poisoning

    Korean version of the Modified Barthel Index

  7. Mortality in intensive care unit

    Time frame: Through study completion, an average of 6 months

    Number of participants with mortality in intensive care unit

  8. Mortality in intensive care unit

    Time frame: Through study completion, an average of 6 months

    Rate of participants with mortality in intensive care unit

  9. In-hospital mortality

    Time frame: Through study completion, an average of 6 months

    Number of participants with in-hospital mortality

  10. In-hospital mortality

    Time frame: Through study completion, an average of 6 months

    Rate of participants with in-hospital mortality

  11. Mortality

    Time frame: At 1, 3, and 6 months after CO poisoning

    Number of participants with all cause mortality

  12. Mortality

    Time frame: At 1, 3, and 6 months after CO poisoning

    Rate of participants with all cause mortality

  13. Length of stay in intensive care unit and hospital

    Time frame: Through study completion, an average of 6 months

    Length of stay in intensive care unit and hospital

  14. Pneumonia

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

    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.

  15. Pneumonia

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

    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.

  16. Shock

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

    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.

  17. Shock

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

    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.

  18. Bradycardia

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

    Number of participants with dropped heart rate indicated drug or interventions

  19. Bradycardia

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

    Rate of participants with dropped heart rate indicated drug or interventions

  20. Hypokalemia

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

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

  21. Hypokalemia

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

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

  22. Hyperkalemia

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

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

  23. Hyperkalemia

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

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

  24. Hyperglycemia

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

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

  25. Hyperglycemia

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

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

  26. Hypophosphatemia

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

    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

  27. Hypophosphatemia

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

    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

  28. Hypomagnesemia

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

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

  29. Hypomagnesemia

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

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

  30. Prolonged prothrombin Time International Normalized Ratio

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

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

  31. Prolonged prothrombin Time International Normalized Ratio

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

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

  32. Prolonged activated partial thromboplastin time

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

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

  33. Prolonged activated partial thromboplastin time

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

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

  34. S100ß (serum)

    Time frame: Within 14 days after CO exposure

    Concentration of S100ß (serum)

  35. Neuronal specific enolase (serum)

    Time frame: Within 14 days after CO exposure

    Concentration of neuronal specific enolase (serum)

  36. Brain magnetic resonance image (MRI)

    Time frame: Within 14 days after CO exposure

    Number of participants with brain injury in brain MRI

  37. Brain magnetic resonance image (MRI)

    Time frame: Within 14 days after CO exposure

    Rate of participants with brain injury in brain MRI

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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