NCT04196907已完成不适用
Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
研究概览
简要总结
The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Weight at least 110 pounds
- •Subjects with the intention of being screened for eligibility to donate blood
- •The subject has given written informed consent 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, infections, abnormalities, etc.
- •Subjects unwilling to remove nail polish or acrylic nails
- •Subjects with blood cancers such as leukemia
- •Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
- •Subjects with self-disclosed/known pregnancy at the time of enrollment
- •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
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
时间窗: 1 hour
Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio.
次要结局
未报告次要终点
研究者
研究点 (2)
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