NCT01100515终止3 期
Phase 3 Study of Hyperbaric Oxygen Therapy in Non-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 179 人开始时间: 2010年4月9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
- 179
- 试验地点
- 2
- 主要终点
- full 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 one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.
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.
- •had transient loss of consciousness (syncope, malaise)
- •carboxyhemoglobin level at presentation >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
full recovery
时间窗: at one month
Full 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
- variations in carboxyhemoglobin levels(at 12 hours from randomization)
- serious adverse events(at one month)
- persistent neurological sequels(at one month)
- delayed neurological sequels(at one month)
研究者
研究点 (2)
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