Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Presence/absence of cognitive impairment
研究概览
简要总结
This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.
The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.
详细描述
The secondary objectives of this study are:
A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.
B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?
C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?
D. To study potential risk factors for cognitive problems at 4 months after ICU discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •The patient (or his/her "trusted person") must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
- •Patient admitted to the ICU and intubated and ventilated for at least 48 hours
排除标准
- •The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contra-indication for a treatment used in this study
- •Patient admitted to intensive care with sedation started for more than 24 hours
- •Patient with neurological or psychiatric (cognitive) disorders
- •Patient admitted for cardiac arrest
- •Patient admitted for stroke
- •Patient admitted for cervical trauma > C6
- •Patient presenting with tracheotomy accompanied by long-term mechanical ventilation
- •Moribund patient or with little hope of survival beyond 48 hours
- •Patients for whom a limitation or termination of care is considered
- •McCabe Score = 0
- •Knauss Scale = C or D
结局指标
主要结局
Presence/absence of cognitive impairment
时间窗: 4 months after ICU discharge
based on D2 test
次要结局
- Test D2 (units = n)(4 months after ICU discharge)
- Wisconsin test(4 months after ICU discharge)
- ICU-SEQ questionnaire(60 +- 3 days after ICU discharge)
- IDS-C Questionnaire(4 months after ICU discharge)
- Questionnaire PDEQ-10(expected average of 5 days (end of ICU stay))
- Assessment of psychotramatisme(60 +- 3 days after ICU discharge)
- Daily average for Behaviour pain scale(expected average of 48 hours)
- CAM ICU score(upon awakening (expected average of 48 hours))
- Peritraumatic distress inventory(expected average of 5 days (end of ICU stay))
- Backwards span test(4 months after ICU discharge)
- Duration of sedation(expected average of 48 hours)
- Assessment of potential impacts(expected average of 5 days (end of ICU stay))
- HADS score(60 +- 3 days after ICU discharge)
- Stroop test(4 months after ICU discharge)
- ICUMT questionnaire(60 +- 3 days after ICU discharge)
- PCLS scale (DSM IV items)(4 months after ICU discharge)
- SF-36(4 months after ICU discharge)
- Forward span test(4 months after ICU discharge)
- Rey 15-word test(4 months after ICU discharge)
- Duration of ventilation(expected average of 36 hours)
- Daily average for RASS scale(Expected maximum of 28 days)
- Verbal fluency test(4 months after ICU discharge)