Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery
研究概览
简要总结
This protocol is a request from Masimo to assist in the collection of data to be used to further refine the accuracy of the monitor's algorithm.
详细描述
The specific aim of this study is to collect data to characterize Masimo's noninvasive Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial blood samples will be measured using standard blood analyzers on site and/or the sponsor's laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients scheduled for elective surgery requiring intra-arterial pressure monitoring
排除标准
- •Age less than 18 years
- •Pregnancy
- •Prisoners
结局指标
主要结局
Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery
时间窗: Five year
Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.
次要结局
未报告次要终点
