SpO2 System Accuracy Testing With Different Sensors
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|ClinicalTrials.gov Identifier: NCT01613222|
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulse Oximetry||Device: Pulse oximetry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SpO2 System Accuracy Testing|
|Actual Study Start Date :||June 19, 2012|
|Actual Primary Completion Date :||February 15, 2013|
|Actual Study Completion Date :||February 15, 2013|
Experimental: Pulse oximetry monitoring
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
Device: Pulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
- Accuracy Root Mean Square (ARMS) [ Time Frame: 60 minutes ]The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).
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): NCT01613222
|United States, Colorado|
|Louisville, Colorado, United States, 80027|
|Study Director:||Jeffrey Conner||GEHC|