Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
- Conditions
- Healthy
- Interventions
- Device: Rainbow DCI and R1-25 sensor
- Registration Number
- NCT03157232
- Lead Sponsor
- Masimo Corporation
- Brief Summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.
The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Subjects must understand and consent to be in the study.
- American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
- Subjects who have any systemic disease at all.
- Subjects who do not understand the study and the risks.
- Smokers.
- Subjects who are pregnant.
- Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Group Rainbow DCI and R1-25 sensor All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
- Primary Outcome Measures
Name Time Method Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation 1-5 hours per subject Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor 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 these 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
🇺🇸Irvine, California, United States