NCT04913038已完成不适用
Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Analgesia Nociception Index (ANI) minimum
研究概览
简要总结
The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.
In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.
To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated
排除标准
- •Non sinusal rythm
- •Pace-macker
结局指标
主要结局
Analgesia Nociception Index (ANI) minimum
时间窗: at 10 minutes before the painful care
ANI minimum
时间窗: at 10 minutes after the painful care
次要结局
- the correlation between ANI minimum and the COMFORT B behavioral scale.(From 10 minutes before the care to 10 minutes after the care)
- the ability of ANI minimum to distingush painful from non painful patient(From 10 minutes before the care to 10 minutes after the care)
- Variation of ANI minimum between before and after a painful care(From 10 minutes before the care to 10 minutes after the care)
- Area under the ROC curve of ANI min calculated over all measurements(From 10 minutes before the care to 10 minutes after the care)
研究者
研究点 (1)
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