NCT02075346已完成不适用
Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time.
研究概览
简要总结
Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.
详细描述
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.
The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 18 years or older (inclusive)
- •Subject is able to participate for the duration of the study
- •Subject is willing to sign an informed consent
排除标准
- •Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors.
- •Physiologic abnormalities that prevent proper application of pulse oximetry sensor.
- •Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
结局指标
主要结局
To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time.
时间窗: The planned duration of the study is 1 month.
次要结局
未报告次要终点
研究者
研究点 (1)
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