Effect of Sleep on the Recovery of Patients Admitted to the ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Rate of ICU mortality
研究概览
简要总结
The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.
详细描述
Critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage I sleep and a paucity of slow wave and REM sleep. The causes of this sleep disruption include the intensive care unit (ICU) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. Surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. Patients in medical, cardiac, and surgical ICUs almost uniformly have fragmented sleep.
Although illness, pain, and medications contribute to sleep disruption in ICU patients, the primary factor causing sleep disruption had been thought to be the ICU environment. Noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the ICU. Patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the ICU. Several studies have confirmed that peak noise levels in ICUs are far in excess of 45 dB during the day and 35 dB at night, which are the recommendations of the Environmental Protection Agency for peak noise levels in the ICU.
The clinical importance of this type of sleep disruption in critically ill patients, however, is not known. The investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any adult patient admitted to the MICU with an expected length of stay of at least 3 days
排除标准
- •frequent overnight neurological checks or frequent peripheral vascular checks
结局指标
主要结局
Rate of ICU mortality
时间窗: at study completion, up to 30 days
rate of mortality while admitted to ICU
Rate of Delirium
时间窗: Once daily throughout study, on average 3-4 days
Assess development of delirium through administration of CAM-ICU and RASS performed daily by nursing staff per routine care. Delirium will be considered present if CAM-ICU is positive or RASS above +1 or below -1 at anytime during study.
Length of Stay in ICU
时间窗: through study completion, an average of 3-4 days
Time spent from admission to ICU until transfer/discharge or study cessation
Overall Hospital Length of Stay
时间窗: at study completion, an average of 5-7 days
Total time spent from admission to ICU until discharge from hospital
Hospital Readmission Rate
时间窗: 30 days after discharge
rate of hospital readmission within 30-days of discharge
次要结局
- ICU sleep score(daily through study completion, an average of 3-4 days)
- Overnight Sound Intensity Levels(through study completion, an average of 3-4 days)
- Overnight Light Intensity Exposure(through study completion, an average of 3-4 days)
- Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)(Study Day 1 and Day 2)
- Concentration of 6-sulphatoxymelatonin (aMT6s)(Study Day 1 and Day 2)
- Concentration of Lipopolysaccharide binding protein (LBP)(Study Day 1 and Day 2)