Pulse oximeter bias was significantly influenced by Sao2 range for all oximeters and probe combinations (Figs. 1 and 2). The relationship between bias and Sao2 was found to be similar statistically, whether analyzed by decadal Sao2 range (Figs. 1 and 2) or by linear regression analysis (not shown). The pattern of bias varied according to oximeter configurations, with all except the Masimo Radical and adhesive probe showing increasing positive bias at low Sao2. The analysis revealed essentially the same results when performed for fractional Sao2 in place of functional Sao2 (not shown).
Gender is a statistically significant determinant of pulse oximeter bias, with the magnitude of the gender bias differences varying with oximeter/probe type and Sao2 range. With five of the six oximeter/probe combinations, females had greater bias in saturation estimates over the saturation range from 60% to 100%.
Multivariate Analysis: Effects of Skin Pigment, Gender, and Sao2 on Bias
Multivariate analysis was used to examine relationships between skin pigmentation classification, gender, age, hemoglobin, Sao2 and probe/oximeter combination and the outcome variable bias. The P values for these analyses are presented in Table 2 for each oximeter/probe combination separately.
Sao2 was a highly statistically significant predictor of bias in all analyses. Although the results in Table 2 are shown for modeling Sao2 as a continuous variable, the results were essentially the same when the analysis was performed with decadal ranges of Sao2.
The effect of skin pigment on bias is also presented in Table 2. Skin pigment significantly predicted bias for the oximeters listed. Similar conclusions were reached when performing the analysis by the ethnicities shown in Table 1. However, the most robust statistical model included gender, skin pigment, and Sao2, with the interaction terms of skin pigment with Sao2 (Skin × Sao2) and gender with Sao2 (Gender × Sao2) included. The interaction for gender with skin pigment was not statistically significant. Age was not statistically significant.
Hemoglobin and gender were too significantly correlated to be separated in the multivariate analysis, 11.8 ± 1.2 (women) vs 13.9 ± 0.8 (men), P < 0.0001. Hemoglobin was statistically significant in place of gender, but with both variables in the model, neither was clearly better.
Sao2 range was a highly significant determinant of RMS error for all the groups shown in the tables except for male subjects using the Nonin 9700 and a permanent probe. Univariate analysis of the effect of skin pigment showed that dark-skinned subjects tended to have higher RMS errors, although this was not statistically significant within every Sao2 range. RMS error for dark-skinned subjects was more than 3.0% in several of the gender/Sao2 combinations.
Multivariate Analysis: Effects of Skin Pigment, Gender, and Sao2 on RMS Error
Table 3 shows the results of multivariate analysis of how RMS error is influenced by gender, skin pigment, and Sao2. Sao2 range was a consistent predictor of RMS error, with error increasing at low Sao2. Skin pigment and gender, or both, were also statistically significant factors with various oximeter–probe combinations. The interaction term for skin pigment with Sao2 and gender with Sao2 were also significant for some oximeter/probe combinations. Two oximeters, the Nonin 9700 with clip-on probe and the Masimo radical with the adhesive probe, did not show an effect of skin pigment, although both had a significant gender effect. Age was not a statistically significant factor on RMS error magnitude.
Confirming a previous study (3), but expanding the oximeters and probes studied, we found that pulse oximeters generally overestimate Sao2 in hypoxic subjects (Sao2 values below 80%.) This bias was generally the greatest in dark-skinned subjects, intermediate for intermediate skin tones, and least for lightly pigmented individuals, although Spo2 was underestimated by one type of oximeter, the Masimo Radical with the adhesive/disposable probe.
Theoretically, the ratio of the pulsatile to the total transmitted red light divided by the same ratio for infrared light should be dependent only on arterial saturation, making pulse oximetry independent of skin color. In practice, venous and tissue pulsation by mechanical force from nearby arteries causes deviations from this ideal. The chromatic characteristics of skin color arise from the interactions of light (primarily absorption and scattering) with the epidermis and the dermis. Because deoxyhemoglobin and melanin are the primary light absorbers in skin at the wavelength used for hemoglobin absorbance, the effective light-path for red light through the finger will vary with skin pigmentation. The magnitude of this effect will vary with skin pigment, tissue perfusion, and with finger geometry, and apparently with oximeter design. Therefore, pulse oximeter performance must be partly based on empirically determined correction factors obtained by in vivo comparison of oximeter readings with measured Sao2 from arterial blood samples of volunteer subjects.
In our 20 yr of testing pulse oximeter accuracy, and probably in other testing laboratories, the majority of subjects have been light skinned. Most pulse oximeters have probably been calibrated using light-skinned individuals, with the assumption that skin pigment does not matter. In addition, several studies have shown that skin pigment does not produce errors in Spo2 estimates at high Sao2 ranges (1,2). The current data show that skin pigment introduces a positive bias at low Sao2 in the Nonin, Masimo, and Nellcor instruments. Our previous study (3) reported similar findings for the Nellcor N-595 clip-on sensors, and for Nonin Onyx and Novametrix 513.
An important finding in the current study is that there is probably a continuous quantitative relationship between skin pigment and oximeter bias. This is seen in Figures 1 and 2 in which, for every oximeter and probe combination, light skin produced the smallest bias across the Sao2 range, intermediate skin tones an intermediate degree of bias, and dark skin the greatest bias. Our earlier study (3) maximized power by studying only two extremes of skin pigment: very dark and very light. The current study enrolled subjects with a full range of skin pigment. The fact that the Spo2 bias changes in an ordered relationship with skin pigment strongly indicates that our findings are due to skin pigment itself, rather than from some other effect. To further pursue this question, we performed all the univariate and multivariate analyses of bias with skin color quantified with a numerical scale (Munsell number) measured by a commercial color laboratory from photographs of the subjects’ hands. This analysis, done by treating skin Munsell number as continuous variable, was not significantly more robust statistically than the simpler categorization of dark, light, and intermediate skin pigment groups, and we have omitted the data here.
As clearly seen in Tables 2 and 3 and Figures 1 and 2, Sao2 is a highly significant determinant of pulse oximeter bias. The most common pattern with early model oximeters was negative bias at lower Sao2 levels. Newer oximeters exhibit both positive and negative bias patterns for different oximeter/probes combinations. Because of the fundamental influence of Sao2 on bias, it is essential to account for this effect when analyzing additional influences such as skin pigment and gender. Therefore, all data are presented in the context of Sao2 range, and analyzed with respect to Sao2 range or continuous Sao2 value.
Gender was a statistically significant univariate predictor of pulse oximeter bias. This observation may relate to smaller finger size and a correspondingly smaller pulsatile signal detected by the sensor, a variant of the problem with light attenuation due to dark skin pigmentation. The female subjects had lower levels of hemoglobin, which was statistically significant in place of gender. Because lower hemoglobin was so highly associated with female gender, it was not possible to statistically separate the contributions of gender and low hemoglobin to oximeter error or bias. Anemia was previously reported to increase bias in pulse oximetry (4). We also cannot eliminate the influence of other confounding variables that we did not measure.
The univariate analyses presented in the tables and figures have important limitations. For example, the possibility of confounding influence among skin pigment, gender, Sao2, and age might affect the results. Further, we recognize that while specific combinations of gender, skin pigment, and Sao2 values produce statistically significant differences, the overall statistical significance of the variables themselves is of greater relevance. Multivariate analysis (Table 2) confirmed this highly significant influence of Sao2 on bias. The most robust statistical model included the interaction of Sao2 with both gender and skin pigment. Also, interaction terms were more important than the influence of both variables themselves. This interaction is clearly seen in the data: bias is not greatly affected by gender or skin pigment at higher Sao2, but increases with oxyhemoglobin desaturation. Age was not a statistically significant variable in the multivariate analysis, although the age range of our healthy subjects was smaller than might be encountered clinically.
This study and a previous study (3) have found that five types of oximeters show varying degrees of bias at low Sao2, suggesting that this bias is a general feature of oximeter design. However, the clip-on probes generally exhibit less bias than the adhesive probes, suggesting that design of sensors or software can affect oximeter accuracy. Because we tested only three types of oximeters in this study and three in a previous study (3), our results may not apply to pulse oximeters made by other manufacturers.
Variability, as measured by RMS error, also increased because of skin pigment. Unlike bias, where positive and negative values may average to give a low mean value, RMS error will also be high with higher variability of bias. RMS error increases at lower Sao2, which was the most important variable. Gender was a small, but statistically significant, factor for several oximeter–probe combinations. Skin pigment was not a statistically significant variable for two oximeters: the Nonin 9700 with clip-on probe and the Masimo radical with adhesive probe. However, similar to the effect of skin pigment on bias, the RMS error was higher in darkly pigmented individuals. RMS error for Sao2 of 70%–100% is used for Food and Drug Administration device approval. Above 3.0 is not acceptable, yet there were several instances of oximeter–probe combinations with values over 3.0. Nearly all values over 3.0 are seen for darkly pigments subjects, and none for lightly pigmented.
The magnitude of the pulse oximeter error due to dark skin pigmentation is relatively small at Sao2 values more than 80%, and probably of no general clinical significance. However, in individuals with darkly pigmented skin, bias of up to 8% was observed at lower Sao2 levels, which may be quite significant under some circumstances. For example, in congenital heart disease, many patients have stable low Sao2 values, and accuracy in an outpatient setting or during surgery may be desired. At high altitude, pulse oximeters are frequently relied on for accurate readings in both research and clinical settings, and the bias at lower Sao2 may be important. Furthermore, studies examining ethnic differences in treatment responses based on Sao2 as determined by pulse oximetry (e.g., treatment of lung diseases) need to account for differences in oximeter readings between light and darkly pigmented subjects. This may be relevant for the United States Food and Drug Administration or to other regulatory bodies to consider this in designing pulse oximeter accuracy standards.
We conclude that skin pigmentation, gender, and type of oximeter probe all affect pulse oximeter bias and error at low Sao2 with a bias of approximately +5% at 75% saturation seen in three manufacturers’ instruments. These deviations may be clinically relevant in some situations.
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