跳至主要内容
临床试验/NCT05454202
NCT05454202已完成不适用

Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月22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
20
试验地点
1
主要终点
Variation of the ANI between before the care and during the care

研究概览

简要总结

Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety.

So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients.

That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)

排除标准

  • Non sinusal heart rate
  • Respiratory rate < 9/min
  • Treated by inotropes
  • Pace-maker
  • Patient in agonal phase
  • Opposition from the guardian

结局指标

主要结局

Variation of the ANI between before the care and during the care

时间窗: From 10 minutes before the care to 10 minutes after the care

次要结局

  • Variation of the ANI between during the care and after the care(From 10 minutes before the care to 10 minutes after the care)
  • Coefficient of correlation between the variation of the ANI and the variation of the CPOT scale between each periods.(From 10 minutes before the care to 10 minutes after the care)
  • Coefficient of correlation between the minANI and the CPOT scale for each periods(From 10 minutes before the care to 10 minutes after the care)
  • Coefficient of correlations between ANImin and CPOT values before, during, and after the painful care session(From 10 minutes before the care to 10 minutes after the care)
  • The discriminatory power of the ANI to separate the non-comfortable and the comfortable population defined by a ≤ 2 threshold on the CPOT scale(From 10 minutes before the care to 10 minutes after the care)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验