Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit. (SleepScan)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
Sleep of critically ill patients is highly disturbed with a high sleep fragmentation; patients spend most of their sleep in very short sleep episodes, lasting less than 10 minutes. Causes of theses sleep alterations are complex including environmental noise (alarms, beepers, conversations...), continuous light, nurse care and repetitive measures of vital parameters.
Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality. Improving sleep quality in critically ill patients is a major challenge to promote ICU patient's recovery.
A very promising treatment is the application of a nocturnal " quiet-time " during which non urgent care, comfort care, systematic measures of vital parameters are delayed and clustered in order to limit room entries. However, " quiet time " procedures have failed to improve sleep quality to date.
A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised. This device (positioned on forehead, and continuously recording noise and light levels) indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room, so that nurses know if patient is sleeping, without entering the room.
Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting room entries, reducing lights and noise, delaying non urgent care...) when patients are sleeping (= EEG-guided strategies) will increase patients sleep quality.
This study will assess the effect of such device on sleep quality in ICU patients. This is a "before / after" design. The first group ("control group"), will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care. Then, procedure will be established collegially with nurses, nurses assistants and doctors. Then, the second group ("treated group") will be recorded with the device displaying the status of the patient (asleep/awake) and all caregivers will be asked to follow the established rules ("EEG-guided sleep protection rules")
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Adults admitted in medical ICU of University Hospital of Poitiers
- •Un-sedated patients displaying a RASS scale between -2 and +1
- •Intubated or spontaneously breathing patients
- •Patient or family have signed the inform consent
排除标准
- •Patients with a central nervous system disease altering sleep scoring
- •Patients who received drugs (<24h) modifying significantly EEG and sleep scoring
- •Patients with cutaneous erosion of the scalp
结局指标
主要结局
Sleep quality
时间窗: Day 1 to Day 4
Proportion of continuous sleep
次要结局
- Sleep fragmentation(Day 1 to Day 4)
- Environmental noise and environmental light(Day 1 to Day 4)
- Sleep interruptions by caregivers(Day 1 to Day 4)
- Sleep quality(Day 2 to Day 4)
- Workload assessed by nurses(Day 1 to Day 4)
- Patient Agitation(Day 1 to day 4)
- Performance of the algorithm(Day 1 to Day 4)
- Patient reported sleep quality(Day 1 to day 4)
- Anxiety level(Day 1 to day 4)
- Respiratory status(At Unit care discharge, an average of 14 days)
- Presence of delirium(Day 1 to Day 4)
- Unit Care length of stay(At Unit care discharge, an average of 14 days)
- Safety of the procedure(One day after Unit Care discharge, an average of 15 days)
- Sleep continuity(Day 1 to Day 4)