Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Validation of psCAM-ICU
研究概览
简要总结
The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.
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
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
- •Patients ventilated or non-ventilated.
排除标准
- •Non-English speaking patients.
- •Children with visual or hearing impairments.
- •Patient/surrogate or physician refusal
- •Moribund and not expected to survive >48 hours
- •Patients in whom comfort care orders have been instituted
- •Patients who are identified for transfer to floor or home regardless of placed orders or bed availability
结局指标
主要结局
Validation of psCAM-ICU
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The investigators will validate the psCAM-ICU against a reference standard delirium assessment in critically ill infants and young children. Critical care physicians and registered nurses will use the psCAM-ICU to determine presence or absence of delirium once daily in critically ill infants and young children from 6 months to less than 5 years of age. The reference standard, a pediatric delirium expert (child psychiatrist or equivalent), will independently evaluate the same patients for presence or absence of delirium using the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) as the foundation of assessment.
次要结局
- Inter-rater reliability of diagnosing delirium(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Long-term cognitive impairment composite(1 year)
- Validation of the Richmond Agitation Sedation Scale (RASS)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Validation of the Withdrawal Assessment Tool-1 (WAT-1)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
Heidi A. Beverley Smith
Assistant Professor of Anesthesiology
Vanderbilt University