Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Repeatability and reproducibility of CO-oximeter and sensor
研究概览
简要总结
Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.
详细描述
This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.
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 one month and older
- •Weight greater than or equal to 3 kg
- •The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
排除标准
- •Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
- •Decision-impaired adult on behalf of a pediatric patient who is unable to assent
- •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.
研究组 & 干预措施
Test subjects
Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.
干预措施: Rad-67 and DCI Mini Sensor (Device)
结局指标
主要结局
Repeatability and reproducibility of CO-oximeter and sensor
时间窗: 120 minutes
The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.
次要结局
未报告次要终点