Verification of a Perfusion Index Parameter in Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Perfusion Index (PI) correlation to doppler measurement
研究概览
简要总结
To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.
详细描述
Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Subjects ≥18 years of age
- •Subject is able to participate for the duration of the study
- •Subject is willing to sign an informed consent
- •Subject weighs >40kg
排除标准
- •Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the 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.
- •Raynaud Syndrome
- •Repeated systolic blood pressure > 140mmHg -
研究组 & 干预措施
Healthy Volunteers
Observational study
结局指标
主要结局
Perfusion Index (PI) correlation to doppler measurement
时间窗: 1 hour
To confirm correlation of Perfusion Index measured by the investigational pulse oximeter PCBA and Market Released sensors to the laser doppler measure of skin perfusion (LDSP) as determined by an overall instantaneous (lag(0)) Spearman rank correlation.
次要结局
未报告次要终点