공시 • Apr 30
Masimo Announces Accuracy of Set Pulse Oximetry on Hospitalized Newborns of All Skin Tones
Masimo announced the findings of a study evaluating the accuracy of Masimo SET pulse oximetry among critically ill neonates and demonstrating less than 1% overall statistical bias. Importantly, there were no clinically meaningful skin pigmentation-related discrepancies and no occult hypoxemic events among Black or Hispanic patients, and in only one Caucasian patient overall. The Neonatal Pulse Oximetry Accuracy and Disparities by Skin Pigmentation (NeoPODS) study findings were presented from the podium at the Pediatric Academic Society in Boston, MA on Monday, April 27th at 10 am EST by lead author Dr. Heather Siefkes on behalf of colleagues at the University of California, Davis and the University of Mississippi, Jackson, alongside online publication in the Journal of Pediatrics. These promising results—from an NIH-funded study that exclusively evaluated Masimo SET in a vulnerable, clinically fragile patient population—add to previously published evidence of its strong performance under the most challenging real-world conditions across all skin tones. The INSPIRE feasibility study, published late last year, showed that SET pulse oximetry performed accurately on critically ill adult medical ICU patients of all skin tones, without any occult hypoxemic events—results similar to the newly published NICU findings, as well as prior evaluations of Masimo SET’s accuracy by skin tone. The results of the full INSPIRE study—involving approximately 500 adult patients—are expected to be published later this year. Even when conducted prospectively, with real-world patients, past studies of pulse oximetry accuracy by skin tone in newborns have not used quantitative, objective measurements to classify pigmentation, or have other methodological shortcomings and limitations. Some prior studies have found that oxygen saturation measured by noninvasive pulse oximetry (SpO2) can overestimate arterial blood oxygen saturation (SaO2), which can lead to occult hypoxemia. Accurate detection of hypoxemia is especially important in NICU patients, since it drives many care pathway decisions. The NeoPODS researchers thus set out to conduct a prospective accuracy study in this patient population, hospitalized NICU patients, with rigorous technical methodology: tightly paired, time-synchronized SpO2-SaO2 measurements and objectively classified skin pigmentation across a range of gestational ages using the same sensors and monitors for all patients. Their primary outcome was the mean bias between paired, simultaneously measured SpO2 and SaO2 values, and their secondary outcome, understanding how that bias differed by skin tone. The researchers enrolled patients between July 2022 and July 2025 at two tertiary NICUs at UC Davis and UM Jackson. The patients were hospitalized newborns up to ten days old, of at least 26 weeks gestational age, with an indwelling arterial catheter and at least one clinically indicated arterial blood draw. Masimo RD SET Neo sensors connected to Radical-7 Pulse CO-Oximeters and Root monitoring platforms were used to continuously record SpO2 data before, during, and after arterial blood gas (ABG) sampling. SaO2 values were directly measured with on-site laboratory analyzers and then paired with the corresponding average SpO2 for the 30 seconds preceding each blood draw. In addition to recording parent-reported race, each patient’s skin tone classification was objectively assessed with a variety of methods, including melanin index and individual typology angle (ITA)—the latter a continuous, quantitative measure of skin pigmentation recommended by the FDA in their 2025 draft guidance for pulse oximeter manufacturers. Data was captured by a SkinColorCatch device, and visual scoring was performed by clinicians blinded to each other’s observations using the Massey-Martin and the Fitzpatrick scales. From among 100 newborns enrolled over the three years, 136 paired SpO2-SaO2 readings collected from 70 patients met the technical criteria for inclusion in the final analysis. The patients’ median gestational age was 28.4 weeks and median gestational weight was 1,085 grams (very low birth weight). As identified by their parents, 40% of the patients were Black and 23% were Hispanic. As objectively assessed, their skin pigmentations spanned the full range of ITA classifications and most, but not the darkest, points of the Massey-Martin and Fitzpatrick scales. The researchers found that overall mean bias between noninvasive SpO2 and invasive SaO2 was -0.98% 2.80% (95% confidence interval, -1.45% to -0.52%), which is not a clinically significant amount, and means that, on average, SpO2 slightly underestimated, not overestimated, SaO2. There was only one data pair meeting the definition of occult hypoxemia (SaO2<88% when SpO2=92%), collected from a patient with the lightest ITA skin tone classification; there were zero cases of occult hypoxemia among Black or Hispanic patients. Turning to accuracy by skin pigmentation, the researchers found that across the objective classification measurements, as well as parent-reported race, there were no statistically or clinically significant differences in mean SpO2-SaO2 bias. For melanin index and ITA classification, when analyzed continuously, bias became slightly less negative with lighter skin pigmentation, but with statistical significance only when ITA analysis was restricted to each patient’s first measurement. There was no significant difference in bias comparing the 3 darkest to the 3 lightest ITA classifications, with all categories except the lightest showing a small negative bias and no statistically significant trend in bias with increasing darkness or lightness. Analyzing bias by Fitzpatrick and Massey-Martin classifications, the researchers similarly found no statistically significant differences (including when analysis was restricted to the first data pair per patient). The authors concluded that their study is “a novel prospective study of newborns using objective skin pigmentation and closely paired SpO2 and SaO2 measurements assessing pulse oximeter accuracy across skin tones. Our study did not find clinically meaningful pigmentation-related bias. We believe this study provides some reassurance on equitable and accurate care in the NICU for this specific device and population. Our study supports the need for additional age-specific and device-specific pulse oximeter performance assessments.
