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Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)

2019年8月5日 更新者:Tufts Medical Center

Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu

The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.

研究概览

地位

完全的

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

观察性的

注册 (实际的)

16

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • Tufts-New England Medical Center Medical ICU and Coronary Care Unit

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Critically ill patients undergoing invasive or noninvasive mechanical ventilation in medical ICU and CCU at Tufts New England Medical Center

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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)
During 24-hour monitorization period (after recruitment into the study)

次要结果测量

结果测量
大体时间
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
During 24-hour monitorization
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
大体时间:During 24-hour monitorization
During 24-hour monitorization
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
During 24-hour monitorization
To assess associations of severity of illness and sedation usage with sleep patterns
大体时间:During 24-hour monitorization period
During 24-hour monitorization period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2006年11月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2017年3月1日

研究注册日期

首次提交

2008年3月12日

首先提交符合 QC 标准的

2008年3月18日

首次发布 (估计)

2008年3月19日

研究记录更新

最后更新发布 (实际的)

2019年8月6日

上次提交的符合 QC 标准的更新

2019年8月5日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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