Early Neurocognitive Rehabilitation in Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Functional Status
研究概览
简要总结
The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients.
The investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years
- •Patients receiving mechanical ventilation for at least 24 hours
- •Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the Sedation Agitation Scale (SAS)
- •Patients haemodynamically stable
- •Informed consent signed by the closest relatives.
排除标准
- •Patients with previous neurologic pathology or focal brain injury before ICU admission
- •Patients with serious psychiatric pathology (major depression, psychosis, bipolar disease) or mentally retarded
- •Patients with sensorial alterations needed to interact with the neurocognitive stimulation programme
- •patients whose closest relatives refuse the subject to be included in the study.
结局指标
主要结局
Functional Status
时间窗: hospital discharge and 3-months after hospital discharge
* Quality of life questionnaire: Satisfaction and Pleasure (Q-LES-Q) (Endicott, J., Nee, J., Harrison, W. \& Blumenthal, R., 1993) * Lawton and Brody Functional Scale (1969)
Attention
时间窗: Hospital discharge and 3-months after hospital discharge
* Verbal attention: Digits Forward subtest of the WAIS III (Wechsler, 1999) * Visual attention: Spatial Localization Forward subtest of the WMS III (Wechsler, 1999) * Sustained/Selective attention: Continuous Performance Test (Conners, 1992)
Psychopathological status
时间窗: Hospital discharge and 3-monts after hospital discharge
* Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) * Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)
Memory
时间窗: Hospital discharge and 3-months after hospital disharge
* Verbal learning and memory: Auditory Verbal Learning Test (Rey, 1964) * Visual learning and memory: 10/36 Spatial Recall Test (Rao, 1992) * Visual recognition: Benton Visual Retention Test (Benton, 1983)
Executive Functions
时间窗: Hospital discharge and 3-months after hospital discharge
* Stimuli alternation and sequencing: Trail Making Test A-B (Mimeo \& Manga, 1999) * Automatic inhibition response: Stroop Test (Golden \& Charles, 1978) * Visual planning: Tower of London (Shallice, 1982). * Phonetic verbal fluency: FAS test (Spreen and Benton, 1995) * Semantic verbal fluency: Animals 1' (Benton \& Hamsher, 1976)
Speed processing
时间窗: Hospital discharge and 3-months after hospital discharge
\- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
次要结局
- Delirium(Every day during ICU stay)
研究者
Lluis Blanch
PhD
Corporacion Parc Tauli