Respiratory failure & ventilation

Assessment of skin pigmentation-related bias in pulse oximetry readings among adults

J Clin Monit ComputPublished Retrospective pooled analysis of nine studies

Authors' conclusion

TruSignal sensors demonstrated higher bias at lower oxygen saturation, with less than 0.5% difference between pigment groups.

Study context

Population
Healthy adults under induced hypoxia; TruSignal SpO2 sensors vs SaO2data points from 131 individuals
Participants
10,800 participants
Comparison
Dark vs light skin pigment
  • Light pigmentn = 8,202reference
  • Dark pigmentn = 2,598
Outcome
Bias, accuracy (Arms) and precision of TruSignal SpO2 sensors
Methodological detailsinduced hypoxia, subgroup analyses by oxygen saturation band
  • Induced hypoxia
  • Subgroup analyses by oxygen saturation band

Pooled result

As reported in the abstract

Bias, band 1 (SpO2 ≥ 70 and ≤ 80%)

Light pigment

+ 0.30%

Dark pigment

+ 0.58%

P = 0.0035

Bias overall
0.14%
Bias across oxygenation bands
less than 1%

Further pooled results

Accuracy (Arms), whole saturation range · within device specifications and regulatory requirements

Determinants of bias (stepwise ANOVA, mixed model)

Oxygenation the dominating factor; bias strongly affected by oxygenation range

Original publication

Assessment of skin pigmentation-related bias in pulse oximetry readings among adults. J Clin Monit Comput. Published 26 October 2023. doi:10.1007/s10877-023-01095-1

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