Targeted Temperature Management Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning: Multicenter Randomized Controlled Clinical Trial (TTM-COHB Trial)
概览
- 阶段
- 不适用
- 干预措施
- Targeted therapeutic hypothermia
- 疾病 / 适应症
- Carbon Monoxide Poisoning
- 发起方
- Wonju Severance Christian Hospital
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Main neurocognitive outcome
- 状态
- 已完成
- 最后更新
- 4天前
概览
简要总结
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).
详细描述
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.
研究者
Yong Sung Cha
Assistant Professor
Wonju Severance Christian Hospital
入排标准
入选标准
- •≥ 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.
排除标准
- •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
- •More than moderate burn or Inhalation burn
- •Burns complicated by other trauma
研究组 & 干预措施
Hypothermia group
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.
干预措施: Targeted therapeutic hypothermia
Normothermia group
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.
干预措施: Targeted therapeutic normothermia
结局指标
主要结局
Main neurocognitive outcome
时间窗: At 6 months after CO poisoning
Global Deterioration Scale \[range 1 - 7 (worst score)\]
次要结局
- mini-mental status exam(At 1 month and 6 months after CO poisoning)
- Glasgow outcome scale(At 1 month and 6 months 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)
- Korean version of the Modified Barthel Index(At 1 month and 6 months after CO poisoning)
- Neurocognitive outcome(At 1 month after CO poisoning)
- Length of stay in intensive care unit and hospital(Through study completion, an average of 6 months)
- S100ß (serum)(Within 14 days after CO exposure)
- Neuronal specific enolase (serum)(Within 14 days after CO exposure)
- Hyperkalemia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Hyperglycemia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Prolonged prothrombin Time International Normalized Ratio(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Prolonged activated partial thromboplastin time(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Brain magnetic resonance image (MRI)(Within 14 days after CO exposure)
- Mortality in intensive care unit(Through study completion, an average of 6 months)
- In-hospital mortality(Through study completion, an average of 6 months)
- Mortality(At 1, 3, and 6 months after CO poisoning)
- Pneumonia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Shock(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Bradycardia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Hypokalemia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Hypophosphatemia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))
- Hypomagnesemia(During the intervention (therapeutic hypothermia or normothermia) period (72 hours))