Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli
研究概览
简要总结
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.
详细描述
The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.
In this study, the PI plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index.
The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 否
入选标准
- •Age > 18 years old.
- •The subject is under general anesthesia
- •The subject have a blood pressure measurement (either arterial or cuff) during the study
- •A signed Informed Consent Form (ICF) has been obtain
排除标准
- •The subject is constantly agitate or moving a lot
结局指标
主要结局
Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli
时间窗: Through study completion, about one year
To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli.
次要结局
- Correlation between the NoL index and the EEG derived pain score(Through study completion, about one year)
- Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)(Through study completion, about one year)