Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- the number of arousals
研究概览
简要总结
Sleep investigation in respirator treated ICU patients: the importance of intensive environment.
Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.
The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.
Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •awake and relevant respirator treated patients with expected 2 or more respirator dags
排除标准
- •GCS < 11
- •cerebral hemorrhage or infarction during the current hospitalization
- •inotropes and/or vasopressors
研究组 & 干预措施
24 hour PSG under ordinary conditions
24 hour PSG in 46 patients under ordinary (routine) conditions
24 hours PSG under protocol 'Quiet in the room'
24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
干预措施: protocol 'Quiet in the room' (Behavioral)
结局指标
主要结局
the number of arousals
时间窗: per hour of sleep
arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
次要结局
- total sleep time(24 hours)
- N1 sleep(24 hours)
- N2 sleep(24 hours)
- N3 sleep(24 hours)
- REM sleep(24 hours)