NCT01727375撤回不适用
Prevention of Delirium With Light in the Intensive Care Unit
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Prevalence of delirium
研究概览
简要总结
The purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients.
详细描述
Patients, who are randomly assigned to the "Lightening arm" will have the circadian light for the whole ICU stay. Light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Male and female patients with age 18 years and above
- •Intensive Care Unit stay ≥ 48 hours
- •Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure >6hours/day and highflow >30 litres) on the day of Intensive Care Unit admission
排除标准
- •Patients with a history Intensive Care Unit stay during the actual hospital stay
- •Patients with delirium on the day of Intensive Care Unit admission
- •Patients with psychiatric diseases
- •Patients with a history of stroke and known cognitive dysfunctions
- •Participation in other clinical studies 10 days before study inclusion and during the study period
- •Psychiatric disease
- •History of stroke with known residual cognitive deficits
- •History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay
- •Analphabetism
- •Unability of German language use
- •Anacusis or Hypoacusis with hearing aid device, Amaurosis
- •Allergies to any ingredient of the electrode fixing material
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
- •Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
结局指标
主要结局
Prevalence of delirium
时间窗: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
次要结局
- Delirium prevalence(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Severity of delirium(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Duration of delirium(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Prevalence of subsyndromal delirium (SSD)(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Severity of anxiety(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Cognitive Dysfunction(ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge)
- Post-Traumatic Stress Disorder (PTSD)(6 and 12 months after hospital discharge)
- Sleep quality(In the night, starting 48 hours after ICU admission)
- ICU length of stay(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Duration of mechanical ventilation(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Hospital length of stay(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks)
- Pain level(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Level of sedation(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Amount of administered opioids(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Amount of administered benzodiazepines(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Amount of administered sedatives(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Amount of administered antipsychotics(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Mortality(ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge)
- Light levels (lux) Light levels (lux)(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Light frequencies(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
- Noise levels (decibel)(Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days)
研究者
Claudia Spies
Univ.-Prof. Dr. Claudia Spies
Charite University, Berlin, Germany
研究点 (2)
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