Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
研究概览
简要总结
In this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients:
- Confusion Assessment Method for the ICU (CAM-ICU)
- Intensive Care Delirium Screening Checklist (ICDSC)
- Nursing-Delirium-Screening-Scale (Nu-DESC)
The definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition, text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the Gold Standard to diagnose delirium.
Primary research question: Does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (DST)?
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
- •Critically ill patient
- •Patient age > 18 years
排除标准
- •Neurosurgical patients
- •Severe brain injury, intracerebral bleeding, stroke
- •Inability to communicate due to anacusia or severe hearing loss
- •Insufficient language comprehension
- •Patients < 24 h total time of Intensive Care Unit stay
- •Deep sedation (RASS < -3) for ≥ 7 days during study participation
结局指标
主要结局
Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
时间窗: Participants will be followed in the 7-days sample period
Used reference standard: DSM-IV TR criteria
Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.
时间窗: Participants will be followed in the 7-days sample period
Used reference standard: DSM-IV TR criteria.
Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.
时间窗: Participants will be followed in the 7-days sample period
Used reference standard: DSM-IV TR criteria
次要结局
- Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status.(Participants will be followed in the 7-days sample period)
- Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.(Participants will be followed in the 7-days sample period)
- Incidence of delirium(Participants will be followed in the 7-days sample period)
- Incidence of Subsyndromale Delirium (SSD)(Participants will be followed in the 7-days sample period)
- Analgesia(Participants will be followed in the 7-days sample period:)
- Ventilator status(Participants will be followed in the 7-days sample period)
- Administered neuroleptics, cumulative(Participants will be followed in the 7-days sample period)
- Administered analgesics, cumulative(Participants will be followed in the 7-days sample period)
- Administered sedatives, cumulative(Participants will be followed in the 7-days sample period)
- Severity of illness(Participants will be followed in the 7-days sample period)
- Antibiotics/infections(Participants will be followed in the 7-days sample period)
- ICU length of stay(Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks)
- Duration of mechanical ventilation(Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks)
- Discharge mode(Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks)
- 28-day mortality(Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks)
- Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.(Participants will be followed in the 7-days sample period)
- Sensitivity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.(Participants will be followed in the 7-days sample period)
研究者
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
Charite University, Berlin, Germany