NCT03128853已完成不适用
Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 3
- 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.
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
研究者
研究点 (3)
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