NCT04581642已完成不适用
Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Efficacy outcome
研究概览
简要总结
In this study we aimed to investigate the performance and effectiveness of NOL and/or NOLedge as a tool for pain assessment in geriatric and critical ill non communicating patients.
Our hypothesis was that NOL and the NOLedge may have good correlation with the health-care professional assessment PAINAD, BPS values, even with the use of the drugs affecting autonomic nervous system.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, Age > 18 years old.
- •Spontaneously breathing or mechanically ventilated
- •Any patient who is unable to express his/her own level of personal pain by using visual scales according to the hospital standard
- •Written informed consent provided by the participant (if they have capacity) or guardian (if they do not have capacity) or a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.
排除标准
- •A patient whose staff or research team believes that his or her participation in the research will cause suffering to the patient.
- •Unstable condition preventing planned routine procedures of care, and conditions precluding the use of PMD-200: absence of sinus cardiac rhythm.
结局指标
主要结局
Efficacy outcome
时间窗: 10 months
The ability of the NOL index to discriminate between periods of painful and non-painful periods
次要结局
- Efficacy outcome(10 months)
研究者
研究点 (1)
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