Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
研究概览
简要总结
This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.
详细描述
Medicine has recently turned from paternalism to patient-centered decisions giving them back autonomy to determine their own treatments and end-of-life directives. Main prerequisite is patient's competence to fully understand information given from medical staff, integrate it and resituate comprehensive willing.
Informed decision-making necessitates patient's ability to appropriately communicate and interact with its environment. Intensive care unit (ICU) patients are often intubated -rendering oral communication impossible- and get sedated with various medications (hypnotics and opioids). Despite an apparently appropriate communication, some of them are confused. Confusion is regularly under diagnosed in ICU settings and necessitates specific tools to be detected, such as CAM-ICU (Confusion Assessment Method in ICU). While not confused, a patient might lack decision-making capacity, meaning that despite obvious communication, more elaborated cognitive function remains uncertain and often inappropriate. Decision-making capacity can be evaluated with dedicated scores such as the Johns Hopkins adapted cognitive examination (ACE). This score has recently been formally translated into French.
The influence of sedatives on decision-making capacity remains unknown to date. This prospective observational multicentre study is intended to investigate the impact of sedatives on the decision-making capacity of ICU patients. Furthermore, each sub-score of the ACE (orientation, language, registration, attention and calculation, and recall) will be investigated according to sedatives types. Patients' decision-making capacity will be clinically assessed by physician, resident and nurse in charge, blindly of ACE result.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Mechanically ventilated patient (intubation or tracheotomy)
- •Not delirious (negative CAM ICU)
- •Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours
- •Receiving sedatives and/or analgesics and/or medications interfering with neurological functions
- •Adult patients with social security coverage
排除标准
- •Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest)
- •Known cognitive disorders (MMSE < 20)
- •Neurodegenerative disease
- •Pregnant woman
- •Protocol refusal by the patient or closest next-of-kin
结局指标
主要结局
Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
时间窗: After inclusion
Global decision-making capacity is evaluated by Johns Hopkins ACE with a 3 groups classification (\< 29 severe alteration, 29-55: moderate alteration; \> 55 light alteration or normal cognitive function).
次要结局
- Analgesics used within 72 hours before decision-making capacity evaluation(Within 72 hours before inclusion)
- Ventilatory free days(Hospital discharge - Up to day 200)
- ICU length of stay(ICU discharge - Up to day 100)
- Hospital length of stay(Hospital discharge - Up to day 200)
- Analgesics used during decision-making capacity evaluation(During inclusion)
- ACE sub-items(Immediately after inclusion)
- Sedatives used during decision-making capacity evaluation(During inclusion)
- Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient(: Immediately after inclusion and prior to Johns Hopkins ACE conduct)
- Sedatives used within 72 hours before decision-making capacity evaluation(Within 72 hours before inclusion)
- Other molecules used within 72 hours before decision-making capacity evaluation(Within 72 hours before inclusion)
- Other molecules used during decision-making capacity evaluation(During inclusion)