跳至主要内容
临床试验/NCT03134313
NCT03134313已完成不适用

Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor

Masimo Corporation2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Accuracy of SpHb on R1-25 by Arms Calculation

研究概览

简要总结

In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

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

入选标准

  • Greater than 18 years old
  • Exclusion criteria:
  • Do not understand the study and the risks involved
  • Deemed ineligible by study test personnel

排除标准

  • 未提供

结局指标

主要结局

Accuracy of SpHb on R1-25 by Arms Calculation

时间窗: 1-5 hours per subject

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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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