Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
研究概览
简要总结
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.
详细描述
Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adults undergoing mechanical ventilation in the medical intensive care unit.
排除标准
- •Central nervous system disease (stroke, seizure, dementia, etc)
- •Metabolic or hypoxic encephalopathy
- •Confirmed or suspected drug overdose
- •Currently receiving neuromuscular blockers
研究组 & 干预措施
Usual care (observational)
Usual care was provided.
Environmental modification
Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.
干预措施: Environmental modification (Behavioral)
Usual care (randomized)
Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol.
结局指标
主要结局
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
时间窗: Average 4 days (patients followed to hospital discharge)
This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.
次要结局
- Subject Tolerance of the Environmental Modification Protocol(Average 4 days (patients followed to hospital discharge))
研究者
Brian Gehlbach
Clinical Associate Professor of Medicine
University of Iowa