Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Accuracy of Sensor by Arms Calculation
研究概览
简要总结
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
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
- •A. Hemodilution Test Procedure
- •Inclusion Criteria:
- •Weight of more than 110 lbs and less than 220 lbs.
- •Physical status of ASA I of II
- •Able to read and communicate in English
- •Has signed written informed consent
- •Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.
排除标准
- •Age less than 18 yrs and greater than 35 years
- •Weight of less than 110 lbs or more than 220 lbs.
- •Hemoglobin less than 12 g/dL
- •ASA physical status of III. IV, V.
- •Subject has known drug or alcohol abuse
- •Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
- •Subject has experienced a head injury with loss of consciousness within the last year
- •Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
- •Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
- •Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
- •Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
- •Baseline heart rate < 50 bpm.
- •Inability to tolerate sitting still or minimal movement for up to 90 minutes
- •Discretion of investigator
- •B. Blood Draw Test Procedure
- •Inclusion Criteria:
- •Subjects must understand and consent to be in the study.
- •Exclusion Criteria
- •Subjects less than 18 years of age.
- •Subjects who do not understand the study and the risks involved.
- •Anyone deemed ineligible by test personnel.
研究组 & 干预措施
Noninvasive Hemoglobin Sensor
All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
干预措施: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) (Device)
结局指标
主要结局
Accuracy of Sensor by Arms Calculation
时间窗: 1-5 hours
Accuracy will 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