NCT01099995终止3 期
Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
University of Versailles2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2010年4月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- complete recovery
研究概览
简要总结
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 15 years of age
- •admitted for domestic CO poisoning within 12 hours after the end of CO exposure
- •initial coma, regardless of consciousness at hospital admission
- •carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively
排除标准
- •poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke)
- •suicide attempt
- •pregnancy
- •contraindications to HBO (circulatory collapse or pneumothorax)
- •technical obstacles to HBO
- •non domestic CO poisoning
- •difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
- •consent refusal
结局指标
主要结局
complete recovery
时间窗: at one month
Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
次要结局
- persistent neurological sequels(at one month)
- delayed neurological sequels(at one month)
- the difference in carboxyhemoglobin levels before/after treatment completion(at 12 hours from randomization)
- serious adverse events(at one month)
研究者
研究点 (2)
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