Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Sound Level
研究概览
简要总结
Specific Aims:
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Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime .
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Obtain baseline light and noise levels in selected medical ICU study rooms.
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Obtain baseline activity level levels in selected medical ICU study rooms.
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Assess baseline information regarding nursing experience, prior training / beliefs regarding sleep promotion in the medical ICU
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Assess the feasibility of instituting a 4 hour (Midnight to 4:00 AM) nocturnal Naptime with minimization of patient interaction via tracking of differences in patient room activity, light and noise levels in control versus intervention patients.
Secondary Aim 3. Examine the associations between Naptime provision and patient sleep quality.
详细描述
The effects of poor sleep are dauntingly pleiotropic. Inasmuch as sleep deprivation can behaviorally and physiologically mimic delirium in the ICU, there is concern that sleep deprived ICU patients are at risk for the increased mortality, longer hospital stays and worsened physical and mental outcomes of hospitalized patients who experience delirium during their admission. Furthermore, lack of sleep has been associated with decrements in FEV1, FVC and maximal inspiratory pressure in non-ICU COPD patients, increases in respiratory muscle fatigue in healthy volunteers and blunted response to hypercapnea in healthy volunteers. Finally, theoretical concerns exist regarding sleep loss putting patients at risk for prolonged bedrest, adverse cardiovascular events, derangement of metabolism and endocrine function as well as immune suppression; though supported by animal models and brief studies in healthy volunteers, no ICU data exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All MICU admissions age 18 and older who are admitted no less than 6 hours and no more than 48 hours prior to intended start of the next potential Naptime (midnight start).
排除标准
- •Patients who are "boarding" from other intensive care units at Yale New Haven Hospital; these patients are not cared for by our providers and would not be subject to our protocols.
- •Patients without an identifiable surrogate who cannot consent for themselves.
- •Comfort care only patients
- •Patients undergoing the hypothermia protocol.
- •Patients enrolled in the MIND*USA delirium study.
- •Non-English speaking patients
结局指标
主要结局
Sound Level
时间窗: Day 1-3 following study enrollment
Sound levels in the patient room will be monitored overnight for the three nights following enrollment. Sound level recordings will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods.
Light Level
时间窗: Day 1-3 following study enrollment
Light levels in the patient room will be monitored overnight for the three nights following enrollment. Light level recordings will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods.
Length of Room Entrances
时间窗: Day 1-3 following study enrollment
The length of room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods.
Length of Rest Periods between Room Entrances
时间窗: Day 1-3 following study enrollment
The length of rest periods between room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods.
Number of Room Entrances
时间窗: Day 1-3 following study enrollment
The number of room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods.
次要结局
- RCSQ score(Day 1-3 following study enrollment)