Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
研究概览
详细说明
Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied.
The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age > 18 yrs
- Receiving invasive or noninvasive mechanical ventilation
- Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV
Exclusion Criteria:
- Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
- On home BiPAP or CPAP
- Depressed sensorium as evidence by Glasgow Coma Score < 10, need for continuous sedation with Riker Score < 2 and inability to follow verbal commands for sustained 3 hours
- Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
- Severe hemodynamic instability (BP< 90 mmHg despite vasopressor therapy) and sepsis
- Recalcitrant hypoxemia (inability to sustain SaO2 > 88%)
- Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
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1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
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2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
大体时间:During 24-hour monitorization period (after recruitment into the study)
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During 24-hour monitorization period (after recruitment into the study)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCU
大体时间:During 24-hour monitorization
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During 24-hour monitorization
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To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
大体时间:During 24-hour monitorization
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During 24-hour monitorization
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To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
大体时间:During 24-hour monitorization
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During 24-hour monitorization
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To assess associations of severity of illness and sedation usage with sleep patterns
大体时间:During 24-hour monitorization period
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During 24-hour monitorization period
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合作者和调查者
调查人员
- 研究主任:Aylin Ozsancak, MD、research fellow
- 首席研究员:Nicholas S Hill, MD、Chair of Pulmonary, Critical Care and Sleep Medicine Division
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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