Correspondence to: performance of the new SmartCardia wireless, wearable oximeter: a comparison with arterial SaO2 in healthy volunteers

Rincon, et al., have published an article comparing the accuracies of three different pulse oximeters: SmartCardia model 7L, Nellcor N-600, and Masimo Radical (model not specified) [1]. The SmartCardia device used an upper-arm sensor, Nellcor an earlobe sensor, and Masimo a fingertip sensor. Healthy volunteers were subjected to stepwise hypoxemic plateaus of 30–60 s duration, with arterial oxygen saturation (SaO2) values going down to roughly 70%. Arterial blood samples were analyzed by CO-oximetry at each plateau (Radiometer ABL-90) as the “gold standard” for accuracy assessment.

The authors show “bias plots” of SpO2 – SaO2 for each of the three pulse oximeters, as well as tabulated results for Bias (mean error), Precision (standard deviation of error) and ARMS (root-mean-square error). The results they show for the Masimo pulse oximeter are totally inconsistent with ClinicalTrials.gov-registered validation data from our laboratories [2]. Rincon quotes a bias ± precision of 2.02 ± 4.6 for Masimo in the full saturation range of 70–100%. The verified and registered values are -0.01 ± 1.16 from a 2017 study. Detailed accuracy statistics comparisons are shown in Table 1. Note that the numbers of volunteer subjects and data pairs are much larger in the Masimo validation dataset. Figure 1 shows the bias plot from Rincon’s paper, compared with the same plot from Masimo laboratories. The difference is obvious.

Table 1 Accuracy statistics for Masimo Radical: Rincon et al.results versus Masimo resultsFig. 1figure 1

Bias plots showing (SpO2 - SaO2) versus SaO2 for Masimo Radical: Rincon et al.results (top) versus Masimo results (bottom)

Close examination of Rincon’s methodology yields a very likely explanation of this discrepancy. They state that their hypoxemic plateaus were maintained “for about 30–60 s at each level.” That is an alarm call to anyone who has performed these desaturation studies. Severinghaus, et al., showed in 1987 that the time delay between oxygenation changes in the lungs and SpO2 readings varies greatly with sensor location, and that delays of a minute or more are common in fingertip sensors [3]. In our own laboratory, we found many subjects with fingertip delays up to two minutes. In contrast, earlobe sensors exhibit a time delay of roughly 10–20 s. The final piece of this puzzle is in Rincon’s Table 1, which suggests that the Masimo fingertip sensor consistently overestimates the SaO2. This is logical because their 30–60 s saturation plateaus were being done in a downward sequence; each new plateau had a lower saturation than the previous one. The plateau duration was not sufficient for a finger sensor to reach its stable value before the procedure moved to the next lower plateau.

In summary, the results published by Rincon et al. for a Masimo pulse oximeter with fingertip sensor are incorrect, and a likely cause is the inadequate hypoxemic plateau stabilization time used in this study. We offer no opinions here regarding the accuracies of the results for the other two pulse oximeters in this study.

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