EEG Data Collection to Evaluate New Patient State Index Performance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Wake up Times, PSI 1.X vs. PSI 2.X
研究概览
简要总结
This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •ASA status of I, II, or III.
- •Subjects undergoing general surgery.
- •neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).
排除标准
- •subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors.
- •inability to obtain subject's physiological, vital, demographics, and real time anesthesia data.
- •Subjects who are pregnant.
- •known history of drug abuse.
- •subjects deemed not suitable for study at the discretion of the Principal Investigator.
研究组 & 干预措施
Standard of care (baseline)
Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.
干预措施: PSI Rev 1.X (Device)
PSI Rev 1.X
The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).
干预措施: PSI Rev 1.X (Device)
PSI Rev 2.X
The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).
干预措施: PSI Rev 2.X (Device)
结局指标
主要结局
Wake up Times, PSI 1.X vs. PSI 2.X
时间窗: From the end of anesthesia to the time of Return of Consciousness
Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.
次要结局
未报告次要终点