Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

NCT ID: NCT04975867

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2025-12-31

Brief 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).

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.

Conditions

Carbon Monoxide Poisoning; Neurologic Sequelae; Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypothermia group

Hypothermia 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.

Group Type: EXPERIMENTAL

Targeted therapeutic hypothermia

Intervention Type: 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.

Normothermia group

For 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.

Group Type: ACTIVE_COMPARATOR

Targeted therapeutic normothermia

Intervention Type: 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.

Interventions

Targeted therapeutic hypothermia

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.

Intervention Type: OTHER

Targeted therapeutic normothermia

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Sung Cha

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Sung Cha, MD

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hospital

Locations

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inha University Hospital

Incheon, Incheon, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 32697512 (View on PubMed)

Other Identifiers

CR220011

Identifier Type: OTHER

Identifier Source: secondary_id

2021-04-043

Identifier Type: OTHER

Identifier Source: secondary_id

TTM-COHB trial

Identifier Type: -

Identifier Source: org_study_id