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临床试验/NCT01681043
NCT01681043已完成不适用

Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment

Vejle Hospital2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
the number of arousals

研究概览

简要总结

Sleep investigation in respirator treated ICU patients: the importance of intensive environment.

Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.

The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.

Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • awake and relevant respirator treated patients with expected 2 or more respirator dags

排除标准

  • GCS < 11
  • cerebral hemorrhage or infarction during the current hospitalization
  • inotropes and/or vasopressors

结局指标

主要结局

the number of arousals

时间窗: per hour of sleep

arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted

次要结局

  • total sleep time(24 hours)
  • N1 sleep(24 hours)
  • N2 sleep(24 hours)
  • N3 sleep(24 hours)
  • REM sleep(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuliya Boyko

MD

Vejle Hospital

研究点 (2)

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