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临床试验/NCT01061242
NCT01061242已完成不适用

Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2010年1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
88
试验地点
2
主要终点
Digit span test score

研究概览

简要总结

The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.

详细描述

Despite decades of scientific interest in evaluating sleep among critically ill patients, little is known about the effects of intensive care unit (ICU)-associated sleep disturbances on patient outcomes. Furthermore, few interventions have been rigorously evaluated to demonstrate efficacy in improving sleep in the ICU and associated patient outcomes. Post-ICU neurocognitive test performance data from this study will be linked to a pre-existing Quality Improvement (QI) project for patient sleep in the MICU. We hypothesize that patients' post-ICU neurocognitive performance (delirium status, attention, short-term memory, processing speed, and executive function) will positively correlate with scores from a previously-published Sleep in the Intensive Care Unit Questionnaire. In addition, we hypothesize that both neurocognitive performance and the Sleep in the Intensive Care Unit Questionnaire will improve during the multi-stage MICU-wide sleep QI project. Our project will provide valuable empirical evidence to help support guidelines for promoting sleep in the ICU setting.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • >=18 years old
  • Spent at least one full night (i.e. 7pm to 7am) in the Johns Hopkins Hospital (JHH) Medical Intensive Care Unit (MICU).
  • Discharged directly from MICU to an in-patient medical step-down or ward bed at JHH.

排除标准

  • Previously enrolled in the study (i.e. repeat discharge from MICU)
  • Pre-existing cognitive impairment, including hepatic encephalopathy, long-term alcohol abuse, and neurological disease (e.g., dementia, prior stroke, cerebral palsy, traumatic brain injury, active seizures)
  • Unable to speak and/or understand English
  • > 96 hours between MICU discharge and testing
  • Visual or hearing impairment, inability to read, or inability to use a writing instrument preventing administration of the neurocognitive tests
  • Spent at least one night in an ICU other than JHH MICU during current hospitalization

结局指标

主要结局

Digit span test score

时间窗: within 96 hours of Intensive Care Unit (ICU) discharge

次要结局

  • Sleep in the ICU Questionnaire(within 96 hours of ICU discharge)
  • Trail Making Test (Part A + B) times(within 96 hours of ICU discharge)
  • Delirium status(within 96 hours of ICU discharge)

研究者

申办方类型
Other

研究点 (2)

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