Using targeted temperature management for severe carbon monoxide poisoning

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

This study is testing whether cooling the body temperature helps people with severe carbon monoxide poisoning recover better than keeping their temperature normal while getting oxygen therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Wonju Severance Christian Hospital (other)
• Locations: 2 sites (Wonju, Gangwon and 1 other locations)
• Trial ID: NCT04975867 on ClinicalTrials.gov

What this trial studies

This trial investigates the neurocognitive outcomes of patients with acute severe carbon monoxide poisoning by comparing the effects of therapeutic hypothermia versus normothermia combined with hyperbaric oxygen therapy. Patients will be identified based on their medical history and carboxyhemoglobin levels, and those meeting the criteria for acute severe carbon monoxide poisoning will receive hyperbaric oxygen treatment. Following this, eligible patients will be randomly assigned to either hypothermia or normothermia treatment, with outcomes assessed at one and six months post-exposure. The study aims to evaluate differences in serum markers and mortality rates between the two treatment groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older who have received hyperbaric oxygen therapy within 24 hours of acute carbon monoxide poisoning.

Not a fit: Patients with prior neurocognitive disorders or those who have experienced cardiac arrest before hyperbaric oxygen therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve neurocognitive recovery in patients suffering from severe carbon monoxide poisoning.

How similar studies have performed: While the approach of using targeted temperature management in this context is innovative, similar studies have shown promise in other critical care scenarios.

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)

Where this trial is running

Wonju, Gangwon and 1 other locations

• Wonju Severance Christian Hospital — Wonju, Gangwon, Korea, Republic of (RECRUITING)
• Inha University Hospital — Incheon, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Yong Sung Cha, MD — Wonju Severance Christian Hospital
• Study coordinator: Yong Sung Cha, MD

Conditions: Carbon Monoxide Poisoning, Neurologic Sequelae, Hypothermia