In Feasibility Study for Large, Prospective, Real-World Trial, Masimo SET Performed Accurately on Critically Ill Adult ICU Patients of All Skin Tones

Masimo (NASDAQ: MASI) today announced the findings of an exploratory analysis for a unique feasibility study published in CHEST Critical Care in which Dr. Andrew Goodwin and colleagues at the Medical University of South Carolina (MUSC) found that Masimo SET pulse oximetry performed accurately among critically ill adult patients of all skin tones, including those with low perfusion requiring vasopressors – and reported zero occult hypoxemic events.¹

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Masimo SET Pulse Oximetry and RD SET Sensors

Such accuracy studies are typically conducted in controlled laboratory conditions with healthy volunteers, or using retrospective data from hospitalized patients. For the first time, the authors demonstrated the feasibility of conducting a technically rigorous accuracy study inside a hospital environment where arterial blood saturation (SaO₂) values invasively obtained at clinical discretion were compared with time-synchronized pulse oximetry saturation (SpO₂) values. This unique design allowed SaO₂-SpO₂ accuracy comparisons to be made at time points that were clinically indicated – initiated by treatment teams in keeping with established practice, both during routine measurement and when spontaneous changes in a patient’s condition necessitated a blood draw – which by definition are important moments to include in any rigorous evaluation of a pulse oximeter’s accuracy in real-world use.

Once complete, the MUSC team’s work will be the largest study of its kind to prospectively examine pulse oximetry performance and the frequency of occult hypoxemia among critically ill adults across the spectrum of light and dark skin tones in a real-world hospital environment. The findings are consistent with previous laboratory and retrospective hospital-based studies which demonstrated Masimo SET’s accuracy on patients with both dark and light skin tones, even during low perfusion, without clinically significant bias between groups.^2-5

In this analysis, the researchers demonstrated that the technically rigorous and methodologically sound approach of laboratory studies could be applied in a real-world clinical setting, using a unique design referred to as the Investigation of Skin Pigmentation Effect on Performance of Pulse Oximetry, or INSPIRE. Such technical rigor was evaluated using data collected from the first 50 of a planned 502 patients. In this dataset, they found that Masimo SET pulse oximetry was accurate among patients of all skin tones—well within FDA specifications for laboratory studies—when compared with arterial blood samples. The modest median bias between SpO₂ and SaO₂ was not clinically significant, and nor was there a clinically significant difference between the median biases for light and dark skin tone patients.