Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

NCT04975867 | Completed DMC

• 3 other identifiers: TTM-COHB trialCR2200112021-04-043
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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).

Conditions

Hypothermia; Carbon Monoxide Poisoning; Neurologic Sequelae

Outcome Measures

Primary Outcomes (1)

• Main neurocognitive outcome

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

  At 6 months after CO poisoning

Secondary Outcomes (37)

• Neurocognitive outcome

  At 1 month after CO poisoning

• Cerebral Performance Category

  At 1 month and 6 months after CO poisoning

• modified Rankin scale

  At 1 month and 6 months after CO poisoning

• Glasgow outcome scale

  At 1 month and 6 months after CO poisoning

• mini-mental status exam

  At 1 month and 6 months after CO poisoning

Study Arms (2)

Hypothermia group

EXPERIMENTAL

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.

Other: Targeted therapeutic hypothermia

Normothermia group

ACTIVE COMPARATOR

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.

Other: Targeted therapeutic normothermia

Interventions

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.

Hypothermia group

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.

Normothermia group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (2)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Inha University Hospital

Incheon, Incheon, 22332, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32697512 BACKGROUND

MeSH Terms

Conditions

Carbon Monoxide Poisoning; Hypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Yong Sung Cha, MD

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of neurocognitive outcomes at 1 and 6 months after CO exposure will be blinded to the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 26, 2021
• Study Start: October 25, 2021
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-06

Locations

KR (2)