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临床试验/NCT02830256
NCT02830256已完成不适用

Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Difference in pain scores or pupillary diameter measures at rest and during care procedures

研究概览

简要总结

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

详细描述

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in pain scores or pupillary diameter measures at rest and during care procedures

时间窗: Through study completion (30 months)

Discriminant validity between NCS-I, BPS and pupillary measurements will follow current recommended method for psychometric assessment of pain tools in critical care patients (Pain Agitation and Delirium Guidelines from the Society of Critical Care Medicine, Barr et al. Crit Care Med 2013). Mann-Whitney-Wilcoxon test will be used to compare values obtained at rest and during the procedures of care.

次要结局

  • Weight kappa coefficient for pain using the NCS-I(Through study completion (30 months))
  • Weight kappa coefficient for pain using the BPS(Through study completion (30 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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