Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor
- Conditions
- Healthy
- Interventions
- Device: Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
- Registration Number
- NCT03134313
- Lead Sponsor
- Masimo Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Greater than 18 years old
- Healthy
Exclusion criteria:
- Do not understand the study and the risks involved
- Deemed ineligible by study test personnel
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R1-25 Sensor Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
- Primary Outcome Measures
Name Time Method Accuracy of SpHb on R1-25 by Arms Calculation 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Clinical Lab
🇺🇸Irvine, California, United States