Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
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|ClinicalTrials.gov Identifier: NCT03157232|
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Rainbow DCI and R1-25 sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||June 19, 2009|
|Actual Primary Completion Date :||June 29, 2009|
|Actual Study Completion Date :||June 29, 2009|
Experimental: Test Group
All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Device: Rainbow DCI and R1-25 sensor
Noninvasive Measurement of SpHb
- Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157232
|United States, California|
|Irvine, California, United States, 92618|