Racial Disparities in Occult Hypoxemia and Clinically Based Mitigation Strategies to Apply in Advance of Technological Advancements

Chesley, Christopher F; Lane‐Fall, Meghan; Panchanadam, Venkat; Harhay, Michael O.; Wani, Arshad A.; Mikkelsen, Mark E.; Fuchs, Barry D.

doi:10.4187/respcare.09769

Cited by 24 publications

(26 citation statements)

References 23 publications

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“…Due to the large number of paired samples a statistically significant difference was calculated between the biases (mean difference of SpO 2 -SaO 2 ) obtained for Black and White subjects; however, this statistical finding is not relevant, as the numerical value is so small (0.15%, or approximately 1/7 of 1%) that it is not clinically significant. Furthermore, "occult hypoxemia," as defined in the recent literature [3][4][5][6][7], did not occur in any Black subjects, and was present in only two data pairs from the White subject data pool. These two data pairs resulted in a 0.2% occult hypoxemia rate for White subjects.…”

Section: Discussionmentioning

confidence: 82%

“…In another retrospective clinical study, Burnett et al found that in 151,000 paired readings of SpO 2 versus SaO 2 , the pulse oximeters showed an incidence of occult hypoxemia (i.e., missed hypoxemic events) of 2.1% in Blacks, 1.8% in Hispanics, and 1.1% in Whites [5]. Recent published studies by Fawzy et al and by Chesley et al yielded similar results and conclusions regarding racial differences in occult hypoxemia [6,7].…”

Section: Introductionmentioning

confidence: 79%

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Racial effects on Masimo pulse oximetry: a laboratory study

Barker

Wilson

2022

J Clin Monit Comput

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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. 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. Statistical bias (mean difference) and precision (standard deviation of difference) were − 0.20 ± 1.40% for Black and − 0.05 ± 1.35% for White subjects. Plots of SpO2 versus SaO2 show no significant visible differences between 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. There were no clinically significant differences in bias (mean difference of SpO2-SaO2) found between healthy Black and White subjects. Occult hypoxemia was rare and did not occur in Black subjects. Masimo RD SET® can be used with equal assurance in people with dark or light skin. These laboratory results were obtained in well-controlled experimental conditions in healthy volunteers—not reflecting actual clinical conditions/patients.

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Section: Discussionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 79%

Racial effects on Masimo pulse oximetry: a laboratory study

Barker

Wilson

2022

J Clin Monit Comput

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“…The recent retrospective studies analyzing the effect of skin pigmentation on pulse oximeter accuracy have had several common methodology limitations. First, most did not indicate pulse oximeter manufacturer, model, or sensor type used for data collection [3,4,6,[13][14][15][16], while the rare investigators who did list manufacturer(s), did not stratify their data by manufacturer [5][6][7]. Prior to this report, only two investigations studying racial differences in pulse oximetry identi ed the manufacturer(s) tested [17,18].…”

Section: Discussionmentioning

confidence: 99%

“…Elevated COHb and MetHb values are known to alter SpO 2 values when measured using conventional pulse oximetry [20]. Furthermore, several of these studies evaluated pulse oximeter accuracy in COVID-19 patients [4,6,7,17], and recent investigations demonstrate that COVID-19 patients can harbor signi cantly elevated endogenous COHb and MetHb values [21].…”

Section: Discussionmentioning

confidence: 99%

“…Due to the large number of paired samples a statistically signi cant difference was calculated between the biases (mean difference of SpO 2 -SaO 2 ) obtained for Black and White subjects; however, this statistical nding is not relevant, as the numerical value is so small (0.15%, or approximately 1/7 of 1%) that it is not clinically signi cant. Furthermore, "missed occult hypoxemia," as de ned in the recent literature [3][4][5][6][7], did not occur in any Black subjects, and was present in only two data pairs from the White subject data pool. These two data pairs resulted in a 0.2% occult hypoxemia rate for White subjects, and both results were from signi cant outliers, while the median tracked accurately (93.2%) with SaO 2 (93%) for both Black and White subjects (Fig.…”

Section: Discussionmentioning

confidence: 99%

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Racial Effects on Masimo Pulse Oximetry: A Laboratory Study

Barker

Wilson

2022

Preprint

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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.

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Clinical Outcomes Associated With Overestimation of Oxygen Saturation by Pulse Oximetry in Patients Hospitalized With COVID-19

Fawzy,

Wu,

Wang

et al. 2023

JAMA Netw Open

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ImportanceMany pulse oximeters have been shown to overestimate oxygen saturation in persons of color, and this phenomenon has potential clinical implications. The relationship between overestimation of oxygen saturation with timing of COVID-19 medication delivery and clinical outcomes remains unknown.ObjectiveTo investigate the association between overestimation of oxygen saturation by pulse oximetry and delay in administration of COVID-19 therapy, hospital length of stay, risk of hospital readmission, and in-hospital mortality.Design, Setting, and ParticipantsThis cohort study included patients hospitalized for COVID-19 at 186 acute care facilities in the US with at least 1 functional arterial oxygen saturation (SaO2) measurement between March 2020 and October 2021. A subset of patients were admitted after July 1, 2020, without immediate need for COVID-19 therapy based on pulse oximeter saturation (SpO2 levels of 94% or higher without supplemental oxygen).ExposuresSelf-reported race and ethnicity, difference between concurrent SaO2 and pulse oximeter saturation (SpO2) within 10 minutes, and initially unrecognized need for COVID-19 therapy (first SaO2 reading below 94% despite SpO2 levels of 94% or above).Main Outcome and MeasuresThe association of race and ethnicity with degree of pulse oximeter measurement error (SpO2 − SaO2) and odds of unrecognized need for COVID-19 therapy were determined using linear mixed-effects models. Associations of initially unrecognized need for treatment with time to receipt of therapy (remdesivir or dexamethasone), in-hospital mortality, 30-day hospital readmission, and length of stay were evaluated using mixed-effects models. All models accounted for demographics, clinical characteristics, and hospital site. Effect modification by race and ethnicity was evaluated using interaction terms.ResultsAmong 24 504 patients with concurrent SpO2 and SaO2 measurements (mean [SD] age, 63.9 [15.8] years; 10 263 female [41.9%]; 3922 Black [16.0%], 7895 Hispanic [32.2%], 2554 Asian, Native American or Alaskan Native, Hawaiian or Pacific Islander, or another race or ethnicity [10.4%], and 10 133 White [41.4%]), pulse oximetry overestimated SaO2 for Black (adjusted mean difference, 0.93 [95% CI, 0.74-1.12] percentage points), Hispanic (0.49 [95% CI, 0.34-0.63] percentage points), and other (0.53 [95% CI, 0.35-0.72] percentage points) patients compared with White patients. In a subset of 8635 patients with a concurrent SpO2 − SaO2 pair without immediate need for COVID-19 therapy, Black patients were significantly more likely to have pulse oximetry values that masked an indication for COVID-19 therapy compared with White patients (adjusted odds ratio [aOR], 1.65; 95% CI, 1.33-2.03). Patients with an unrecognized need for COVID-19 therapy were 10% less likely to receive COVID-19 therapy (adjusted hazard ratio, 0.90; 95% CI, 0.83-0.97) and higher odds of readmission (aOR, 2.41; 95% CI, 1.39-4.18) regardless of race (P for interaction = .45 and P = .14, respectively). There was no association of unrecognized need for COVID-19 therapy with in-hospital mortality (aOR, 0.84; 95% CI, 0.71-1.01) or length of stay (mean difference, −1.4 days; 95% CI, −3.1 to 0.2 days).Conclusions and RelevanceIn this cohort study, overestimation of oxygen saturation by pulse oximetry led to delayed delivery of COVID-19 therapy and higher probability of readmission regardless of race. Black patients were more likely to have unrecognized need for therapy with potential implications for population-level health disparities.

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Racial Disparities in Occult Hypoxemia and Clinically Based Mitigation Strategies to Apply in Advance of Technological Advancements

Cited by 24 publications

References 23 publications

Racial effects on Masimo pulse oximetry: a laboratory study

Racial effects on Masimo pulse oximetry: a laboratory study

Racial Effects on Masimo Pulse Oximetry: A Laboratory Study

Clinical Outcomes Associated With Overestimation of Oxygen Saturation by Pulse Oximetry in Patients Hospitalized With COVID-19

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