Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Comparison of propofol concentrations in exhaled breath to those in plasma
研究概览
简要总结
This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 18 and 65 years old
- •Healthy Male or Female
- •BMI between 18.5 and 30.0
- •Have a planned surgery or other medical procedure requiring anesthesia
- •Physical status ASA I, II, or III
排除标准
- •Known allergy to any component of propofol formulation components
- •History of lung disease or tobacco use in the past 5 years
- •Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation
结局指标
主要结局
Comparison of propofol concentrations in exhaled breath to those in plasma
时间窗: Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.)
次要结局
未报告次要终点