New Study Investigates the Ability of Masimo ORi to Provide Early Warning of Hypoxemia During Endotracheal Intubation in ICU Patients

Masimo (NASDAQ: MASI) announced today the findings of a prospective, blinded observational study published in Annals of Intensive Care in which Dr. Jean-Baptiste Lascarrou and colleagues at the Centre Hospitalier Universitaire in Nantes, France evaluated the ability of Masimo ORi to predict mild hypoxemia during endotracheal intubation (ETI) in ICU patients.¹ They concluded that the time between decrease in ORi and subsequent decrease in oxygen saturation (SpO₂) “may allow preventive action,” and that a higher ORi value during preoxygenation was “independently protective against hypoxemia.”

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Masimo Root with ORi (Photo: Business Wire)

ORi, available outside the U.S., is a noninvasive and continuous trending index that extends oxygen monitoring on patients on supplemental oxygen. Enabled by the multi-wavelength rainbow Pulse CO-Oximetry platform, ORi is provided alongside oxygen saturation (SpO₂) measured by clinically proven Masimo SET pulse oximetry.

Noting the importance of optimizing preoxygenation in patients needing ETI, the researchers sought to evaluate whether ORi could provide early warning of impending hypoxemia during the procedure, because ORi “supplies information beyond the range explored by SpO_2.” Of the 51 patients who met the inclusion criteria, ORi (alongside SpO₂) was monitored using Masimo Radical-7 Pulse CO-Oximeters and rainbow fingertip sensors when preoxygenation began. Values were recorded every two seconds, and attending clinicians were not aware of these values. The primary endpoint measured was the time between ORi decreasing below 0.4 and the onset of mild hypoxemia (defined as SpO₂ < 97%). Secondarily, the investigators evaluated whether a decline in ORi during preoxygenation predicted the occurrence of mild hypoxemia during ETI.

Analyzing areas under the ROC curve, the researchers found that ORi during preoxygenation predicted SpO₂ < 97% during intubation (0.73; 95% confidence interval of 0.58 – 0.88). By contrast, SpO₂ at the end of preoxygenation was “poorly predictive” (0.54; 95% CI 0.40 – 0.67). Using univariate analysis, they found that a higher ORi value during preoxygenation was associated with a less frequent occurrence of SpO₂ < 97% (odds ratio of 0.09; 95% CI 0.01 – 0.69, p = 0.0199) and that “the highest ORi value during preoxygenation remained significantly associated with a lower risk of SpO₂ < 97% during ETI, after adjustment for ETI duration and BMI (odds ratio of 0.76; 95% CI 0.61 – 0.95, p = 0.0141).”