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临床试验/NCT01416675
NCT01416675已完成不适用

Delirium Assessment in the Pediatric Intensive Care Unit

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)

研究概览

简要总结

Objective: Studies documenting the prevalence of delirium among critically ill children are still rare. Emerging literature from psychiatric specialists reports the prevalence of delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely to be an underestimation of the true prevalence, as demonstrated in early adult delirium literature, especially given the absence of validated bedside tools to diagnose delirium in the PICU.

The primary aim of this study is to validate the German version of the Pediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence Delirium (PAED) Scale.

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
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatric ICU patients

排除标准

  • non-German-speaking
  • inability to communicate due to severe hearing loss or brain injury
  • preexisting psychosis
  • mental retardation due to a specific diseases (e.g. M. Crouzon, Kabuki Syndrome, Z.n. Battered Child, Atrogryposes multiplex congenita)

结局指标

主要结局

Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)

时间窗: The participants will be followed up in the sample period (1 to 21 days)

次要结局

  • Specifity of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • Specifity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)(The participants will be followed up in the sample period (1 to 21 days))
  • Quality of Analgesia(The participants will be followed up in the sample period (1 to 21 days))
  • Sensitivity of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • Positive predictive value of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • Depth of sedation(The participants will be followed up in the sample period (1 to 21 days))
  • Prevalence of delirium(The participants will be followed up in the sample period (1 to 21 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin

Charite University, Berlin, Germany

研究点 (1)

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