The accuracy of pulse oximetry in measuring oxygen saturation by levels of skin pigmentation: a systematic review and meta-analysis

Chunhu Shi, Mark Goodall, Jo Dumville, James Hill, Gill Norman, Oliver Hamer, Andrew Clegg, Caroline Leigh Watkins, George Georgiou, Alexander Hodkinson, Catherine Elizabeth Lightbody, Paul Dark, Nicky Cullum, Chunhu Shi, Mark Goodall, Jo Dumville, James Hill, Gill Norman, Oliver Hamer, Andrew Clegg, Caroline Leigh Watkins, George Georgiou, Alexander Hodkinson, Catherine Elizabeth Lightbody, Paul Dark, Nicky Cullum

Abstract

Background: During the COVID-19 pandemic, there have been concerns regarding potential bias in pulse oximetry measurements for people with high levels of skin pigmentation. We systematically reviewed the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry.

Methods: We searched Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform (up to December 2021) for studies with SpO2-SaO2 comparisons and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of skin pigmentation and ethnicity and used these pooled mean biases and SDs to calculate accuracy root-mean-square (Arms) and 95% limits of agreement. The review was registered with the Open Science Framework ( https://osf.io/gm7ty ).

Results: We included 32 studies (6505 participants): 15 measured skin pigmentation and 22 referred to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with the high level of skin pigmentation (pooled mean bias 1.11%; 95% confidence interval 0.29 to 1.93%) and people described as Black/African American (1.52%; 0.95 to 2.09%) (moderate- and low-certainty evidence). The bias of pulse oximetry measurements for people with other levels of skin pigmentation or those from other ethnic groups is either more uncertain or suggests no overestimation. Whilst the extent of mean bias is small or negligible for all subgroups evaluated, the associated imprecision is unacceptably large (pooled SDs > 1%). When the extent of measurement bias and precision is considered jointly, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%).

Conclusions: Pulse oximetry may overestimate oxygen saturation in people with high levels of skin pigmentation and people whose ethnicity is reported as Black/African American, compared with SaO2. The extent of overestimation may be small in hospital settings but unknown in community settings. REVIEW PROTOCOL REGISTRATION: https://osf.io/gm7ty.

Keywords: Arterial blood oxygen saturation; Ethnicity; Measurement bias; Pulse oximetry; Skin pigmentation; Systematic review.

Conflict of interest statement

NC reports research grants from the National Institute for Health Research and the Accelerated Access Collaborative at NHS England and NHS Improvement and payments were made to the University of Manchester. PD is the National Deputy Medical Director, NIHR Clinical Research Network Coordinating Centre, UK, developing and delivering clinical research in the subject area and contributing to developing and implementing NIHR’s Equality, Diversity and Inclusion strategy. All other authors have declared that no competing interests exist.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The study selection flowchart. This flowchart shows the number of records and studies at each stage of the study selection process
Fig. 2
Fig. 2
Risk of bias assessment results. The left section of this figure shows risk of bias judgements for each domain of the QUADAS-2 tool for each study and the right section shows applicability judgements for each concern domain of the QUADAS-2 tool for each study. Please see Additional file 4: Box S3 for all signalling questions used in the QUADAS-2 assessment and further considerations

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