Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 28
- 主要终点
- Incidence rate of delirium
研究概览
简要总结
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment.
The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.
详细描述
The "Bundle of Actions" is a coordinated and specific action plan, which has already been validated, focusing on the coordination of wake-up and respiration, the management of delirium, as well as the early mobility of the patient. Innovation consists of simple, reproducible nursing care that reduces triggers of delirium; as well as the use of two new approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment of the patient in the management of his pain and well-being.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the trusted person and the patient upon waking
- •Hospitalized in reanimation service (first hospitalization or transfer of another service)
- •48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
- •Francophone (able to understand all evaluations)
- •Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above:
- •Absence of pre-existing cognitive impairment (patients whose relative has completed the IQCode questionnaire and whose score is <3.4 points)
- •Visual, auditory (authorized equipment) skills and adequate oral or written expression for the proper conduct of neuropsychological tests.
排除标准
- •Pregnant women
- •Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...)
- •Evolving psychiatric illness (including severe depression)
- •Voluntary drug poisoning
- •Patients who have already participated in the study
结局指标
主要结局
Incidence rate of delirium
时间窗: Day 60
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.
次要结局
- Quality of life at one year(Year 1)
- Duration of the delirium between the diagnosis and the resolution of the delirium(Day 60)
- Evaluation of cognitive and psycho-behavioral functions.(Day 60 and month 3)