Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Alcohol elimination time constant
研究概览
简要总结
This prospective, randomized control trial will use passive, isocapnic hyperventilation, applied via the ClearMateTM device (Thornhill Medical, Inc) versus controls receiving standard of care supportive management for severe alcohol intoxication to assess for enhanced ethanol elimination kinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •intoxicated requiring admission to an emergency unit
排除标准
- •Liver or renal disease
研究组 & 干预措施
ClearMate Intervention
Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics.
干预措施: ClearMateTM (Device)
Supportive Management
Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics.
结局指标
主要结局
Alcohol elimination time constant
时间窗: 6-24 hours
From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated
次要结局
未报告次要终点