Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 7
- 主要终点
- Accuracy of hemoglobin measurement
研究概览
简要总结
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
详细描述
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Greater than one month
- •Weight: Greater than or equal to 3kg
- •The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
排除标准
- •Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
- •Subjects deemed not suitable for the study at the discretion of the investigator
- •Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
- •Decision-impaired adult and pediatric subjects who are unable to give consent and assent
研究组 & 干预措施
Test subjects
All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.
干预措施: Rad-67 Pulse oximeter (Device)
结局指标
主要结局
Accuracy of hemoglobin measurement
时间窗: Up to 2 hours per subject
Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
次要结局
未报告次要终点