Abstract
PURPOSE: Recent reports that pulse oximeters may overestimate oxygen saturation in individuals with darker skin pigmentation have prompted concerns from regulatory authorities regarding racial bias. We investigated the performance of TruSignal SpO2 sensors (GE Healthcare, Helsinki, Finland) in adults with varying skin pigmentation. METHODS: A retrospective study was conducted using a set of pooled assessments of SpO2/SaO2 measurements from nine studies to assess bias, accuracy (A(rms)), and precision of TruSignal sensors in healthy adults under induced hypoxia. Subgroup analyses were performed based on oxygen saturation levels (band 1, ≥ 70 and ≤ 80%; band 2, > 80 and ≤ 90%; band 3, > 90 and ≤ 100%). RESULTS: Of the 10,800 data points from 131 individuals, 8,202 (75.9%) and 2,598 (24.1%) were assigned to the light and dark pigment groups, respectively. Bias was 0.14% overall and less than 1% across oxygenation bands. The difference in bias between dark and light pigment groups was statistically significant at the low oxygenation band with SpO2 ≥ 70 and ≤ 80% (+ 0.58% and + 0.30% respectively; p = 0.0035). Throughout the saturation range, A(rms) was 1.64% in the light and 1.71% in the dark pigment group, within device specifications and regulatory requirements. Oxygenation was the dominating factor in stepwise ANOVA modeling. The mixed model also showed that bias was strongly affected by the oxygenation range. CONCLUSION: TruSignal sensors demonstrated higher bias at lower oxygen saturation, with less than 0.5% difference between pigment groups. These findings raise new questions, such as ways to improve pulse oximetry measurements during challenging clinical conditions, including low perfusion.