NCT04224246已完成2 期
Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean from Mechanical Ventilation
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients having poor sleep with Gamma-OH
研究概览
简要总结
The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intubated at least 24 hours
- •difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
- •Patients will be included after to obtain inform consent.
排除标准
- •neuromuscular disease
- •central nervous disease
- •psychiatric disease
- •severe obesity
研究组 & 干预措施
One arm with Gamma-OH® treatment
Experimental
Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m.
干预措施: Gamma Hydroxybutyrate (Drug)
结局指标
主要结局
Proportion of patients having poor sleep with Gamma-OH
时间窗: Hour24
Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.
次要结局
未报告次要终点
研究者
研究点 (1)
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