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临床试验/NCT02603731
NCT02603731已完成不适用

Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2015年8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
183
试验地点
1
主要终点
Delirium at any time point

研究概览

简要总结

This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and to identify risk and preventive factors associated with development of delirium.

Especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.

详细描述

A common problem for patients in the ICU is episodes of delirium. Recent trials have described incidences ranging from 60-87% of patients in a number of different countries. Delirium is a condition with fluctuating conscience, disorganized thinking and disturbance of the sleep/wake cycle. Many patients with delirium experience hallucinations and agitation which can be very unpleasant for both patients and their families.

Some risk factors for the development of delirium well known, e.g. dementia, hypertension, illness severity (SAPS II score), delirium on the previous day, mechanical ventilation, emergency surgery and metabolic acidosis. The effect of sedative drug administration is not clear, as studies has been inconclusive.

Even though studies regarding the impact of sleep deprivation on development of delirium have been inconclusive, there is no doubt that delirious patients have a disturbed sleep-wake cycle, sleep architecture and circadian rhythm.

At the intensive care unit at the Department of Anesthesiology at Køge Hospital, three out of nine rooms have a simulated circadian light installed. The idea is that this light rhythm may help to keep a natural circadian rhythm, minimizing the risk of delirium.

With this descriptive and retrospective cohort study, the investigators therefore want to describe the incidence and possible risk- and preventive factors of delirium for the participants (ICU patients at Køge Hospital), and with a special focus on the possible effect of imitated circadian light..

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients >18 years of age admitted to the ICU at Køge Hospital in the study period

排除标准

  • Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period
  • No CAM-ICU scores during the ICU stay
  • Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage)
  • Severe dementia documented in electronic patient charts (OPUS)
  • Patients not receiving active treatment (moribund patients)

结局指标

主要结局

Delirium at any time point

时间窗: Throughout study period, up to 6 months

Incidence of patients with delirium during ICU-stay defined as at least one positive Confusion Assessment Method for the ICU (CAM-ICU) score or CAM-ICU negative delirium treated with anti-psychotics.

次要结局

  • Circadian light exposure(Throughout study period, up to 6 months)
  • Delirium in patients treated with hypnotics(Throughout study period, up to 6 months)
  • Delirium in patients treated with steroids(Throughout study period, up to 6 months)
  • Delirium related to number of ventilator days(Throughout study period, up to 6 months)
  • Delirium related to sedation(Throughout study period, up to 6 months)
  • Distribution of types of delirium(Throughout study period, up to 6 months)
  • Days with delirium(Throughout study period, up to 6 months)
  • Mortality(Throughout study period, up to 6 months)
  • Demographic differences(Throughout study period, up to 6 months)
  • Delirium and Simplified Acute Physiology Score (SAPS)(Throughout study period, up to 6 months)
  • Delirium related to admission type(Throughout study period, up to 6 months)

研究者

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

Stine Estrup

Junior Doctor

Zealand University Hospital

研究点 (1)

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