Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

N/AActive Not RecruitingNCT04975867

Wonju Severance Christian Hospital46 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Carbon Monoxide Poisoning Neurologic Sequelae Hypothermia

Interventions

Targeted therapeutic hypothermiaOTHER

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.

Targeted therapeutic normothermiaOTHER

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Locations (2)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inha University Hospital

Incheon, Incheon, South Korea

Outcomes

Primary Outcomes

Main neurocognitive outcome

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

Time frame: At 6 months after CO poisoning

Secondary Outcomes

Neurocognitive outcome

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

Time frame: At 1 month after CO poisoning

Cerebral Performance Category

Cerebral Performance Category \[range 1 - 5 (worst score)\]

Time frame: At 1 month and 6 months after CO poisoning

modified Rankin scale

modified Rankin scale \[range 0 - 6 (worst score)\]

Time frame: At 1 month and 6 months after CO poisoning

Glasgow outcome scale

Glasgow outcome scale \[range 1 (worst score) - 5\]

Time frame: At 1 month and 6 months after CO poisoning

mini-mental status exam

Time frame: At 1 month and 6 months after CO poisoning

Korean version of the Modified Barthel Index

Time frame: At 1 month and 6 months after CO poisoning

Mortality in intensive care unit

Number of participants with mortality in intensive care unit

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Mortality in intensive care unit

Rate of participants with mortality in intensive care unit

Time frame: Through study completion, an average of 6 months

In-hospital mortality

Number of participants with in-hospital mortality

Time frame: Through study completion, an average of 6 months

In-hospital mortality

Rate of participants with in-hospital mortality

Time frame: Through study completion, an average of 6 months

Mortality

Number of participants with all cause mortality

Time frame: At 1, 3, and 6 months after CO poisoning

Mortality

Rate of participants with all cause mortality

Time frame: At 1, 3, and 6 months after CO poisoning

Length of stay in intensive care unit and hospital

Time frame: Through study completion, an average of 6 months

Pneumonia

Number of participants with the diagnosis of pneumonia. Diagnosis is established when the following two criteria are met: 1) the appearance of a new infiltrate or consolidation on chest x-ray; and 2) leukocytosis, or leukopenia, or the significant presence of meaningful bacteria in a sputum culture with the absence of other infections.