Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

Last updated: July 22, 2024
Sponsor: Wonju Severance Christian Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Targeted therapeutic normothermia

Targeted therapeutic hypothermia

Clinical Study ID

NCT04975867
TTM-COHB trial
CR220011
2021-04-043
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 afterHBO).

  • Signed informed consent prior to study entry.

Exclusion

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 intravenousflumazenil administration or history taking at the emergency department

  • Absolute contraindication for TH (active severe bleeding and profound shock notcontrolled by vasoactive drugs)

  • No admission

  • The significant co-ingested drug levels, which are alter the consciousness, isconfirmed 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)

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Targeted therapeutic normothermia
Phase:
Study Start date:
October 25, 2021
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Wonju Severance Christian Hospital

    Wonju, Gangwon 26426
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

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