Dynamic Light Application to Prevent ICU Acquired Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- delirium outcome
研究概览
简要总结
Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known
Goals/endpoints:
To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients > 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room.
Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups
详细描述
STUDY DESIGN This is a prospective randomized, single centre trial. The proposed starting date is 01-july- 2011 and the duration of the study will be 15 months.
All ICU patients who are expected to have an ICU stay of more than 24 hours are potential eligible. On ICU admission, patients will be screened for eligibility. The patients' demographics, patients' health status, medication use, APACHE II score, SOFA score and admission diagnosis will be reported at baseline. Before recruitment and enrollment in the study, each patient and/or relative will be given full explanation of the study and will be informed that they are free to discontinue their participation in the study at any time.
When considered eligible, patients will be given a unique patient number in consecutive order and will be assigned to the treatment corresponding with this number. Patients will be randomized in a one-on-one fashion according to a computer generated randomization list between Standard Care and Standard Care + DLA. The randomization list will be kept at the data co-ordination centre.
All of the 20 patient rooms on the 2 ICU wards are equipped with a special lighting system. This lighting system can offer the standard basic lighting in the patient room, with a set intensity and light colour, or the DL setting which offers changing light conditions depending on the time of the day, following a rhythmic pattern. In addition, all rooms have a basic low-intensity orientation light, which is turned on during night-time in all rooms.
The switch between the two modes is regulated centrally on a control panel that is located in the nursing station and cannot be altered in the patient-room
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •ICU-patients >18 yrs old
- •expected duration of stay > 24 hrs
排除标准
- •life expectancy of <48 hrs on ICU admission
- •necessity of prolonged deep sedation
- •blindness
- •inability to speak or understand dutch
研究组 & 干预措施
Dynamic light
ICU patients exposed to dynamic light during ICU stay
干预措施: Dynamic Light (Other)
Normal Light
control group is exposed to normal light during ICU stay
结局指标
主要结局
delirium outcome
时间窗: duration of ICU stay(average duration 5 days)
This is a composite endpoint of incidence of delirium during ICU stay, 28-day delirium free days (28-DFD) and 28-day ventilator free days (28-VFD)
次要结局
- ICU length-of-stay and ICU mortality(duration of ICU stay, (average duration 5 days))
- Hospital length-of-stay and hospital mortality(duration of hospital stay (average duration 14 days))
- data of Health-related Quality of Life (HrQoL) questionnaires(during ICU stay and 3, 6 and 12 months after ICU discharge)
- duration of mechanical ventilation(duration of ICU stay (average duration 5 days))
- serum levels of inflammatory markers and markers of brain damage(duration of ICU stay (average duration 5 days))
- urinary levels of markers of circadian rhythm(duration of ICU stay (average duration 5 days))
- Delirium-free days without coma in 28 days(28 days)
研究者
K.S. Simons
Drs
Jeroen Bosch Ziekenhuis