Year: 2022
Type: article
Abstract: PURPOSE: Recent publications have suggested that pulse oximeters exhibit reduced accuracy in dark-skinned patients during periods of hypoxemia. Masimo SET® (Signal Extraction Technology®) has been designed, calibrated, and validated using nearly equal numbers of dark and light skinned subjects, with the goal of eliminating differences between pulse oximetry saturation (SpO2) and arterial oxygen saturation (SaO2) values due to skin pigmentation. The accuracy concerns reported in dark-skinned patients led us to perform a retrospective analysis of healthy Black and White volunteers.METHODS: Seventy-five subjects who self-identified as being racially Black or White underwent a desaturation protocol where SaO2 values were decreased from 100% to 70%, while simultaneous SpO2 values were recorded using Masimo RD SET® sensors.RESULTS: Statistical bias difference (mean error) and precision (standard deviation of error) were -0.20 + 1.40% for Black and -0.05 + 1.35% for White subjects. Plots of SpO2 versus SaO2 appear nearly identical for both races throughout the saturation range from 70% to 100%. Box plots grouped in 1% saturation bins, from 89-96%, and plotted against concomitant SaO2 values, show that occult hypoxemia (SaO2 < 88% when SpO2 = 92-96%) occurred in only 0.2% of White subject data pairs, but not in any Black subjects. CONCLUSIONS: There were no clinically significant differences in bias (mean difference of SpO2-SaO2) found between Black and White subjects. Occult hypoxemia was rare and did not occur in Black subjects. Masimo RD SET® is highly accurate and can be used with equal assurance in people with dark or light skin.
Authors: Steven J. Barker, William C. Wilson
Institution: Masimo (United States)
Language: English
Subfield: Biomedical Engineering
Field: Engineering
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $3,390
Funder: Masimo
OpenAlex ID: W4309081334