跳至主要内容
临床试验/NCT02760446
NCT02760446已完成不适用

Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2015年11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
115
试验地点
2
主要终点
Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).

研究概览

简要总结

Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Adult, > or equal to 18-yr
  • Richmond Agitation Sedation Scale (RASS) > or equal -3
  • Francophone

排除标准

  • Diagnostic of cognitive disorders
  • Admission for brain injury
  • Psychotic disorders
  • Diagnostic of cognitive disorders
  • Visual or auditory impairments

结局指标

主要结局

Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).

时间窗: Day 0

Investigators team: evaluation by the CAM- ICU in French and Intensive Care Delirium Screening Check list (ICDSC) during 2 minutes for the concomitant CAM- ICU and ICDSC , carried out at 30 minutes intervals by two Clinical Research Nurse of the investigative team . The neuropsychologist will do the evaluation according to criteria common DSM5. Neuropsychologists now used DSM 5 criteria to diagnose delirium at our institution since new DSM 5 criteria have been published in French.

次要结局

  • Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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