Noninvasive Hemoglobin Testing in Prospective Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Rad-67 Sensitivity
研究概览
简要总结
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.
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 and/or unable 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
- •Subjects 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
- •Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
研究组 & 干预措施
Test subjects
All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.
干预措施: Rad-67 Pulse oximeter & DCI Mini sensor (Device)
结局指标
主要结局
Rad-67 Sensitivity
时间窗: Up to one hour per subject
Sensitivity of the the Rad-67 will be determined for its use in a blood donation center
Rad-67 Specificity
时间窗: Up to one hour per subject
Specificity of the the Rad-67 will be determined for its use in a blood donation center
次要结局
未报告次要终点