Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

Wonju Severance Christian Hospital

Status: Active, not recruiting

Conditions: Carbon Monoxide Poisoning; Hypothermia; Neurologic Sequelae

Treatments: Other: Targeted therapeutic normothermia; Other: Targeted therapeutic hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT04975867

2021-04-043 (Other Identifier)

CR220011 (Other Identifier)

TTM-COHB trial

Details and patient eligibility

About

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).

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Hypothermia group

Experimental group

Description:

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.

Treatment:

Other: Targeted therapeutic hypothermia

Normothermia group

Active Comparator group

Description:

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.

Treatment:

Other: Targeted therapeutic normothermia