May 18, 2022 – Masimo announced the FDA 510(k) clearance of the absolute accuracy of O3® regional oximetry for use in monitoring adult somatic tissue oxygen saturation. With this clearance, O3 is now indicated for use in monitoring both absolute and trending regional oxygen saturation (rSO2) in the U.S. in both cerebral and somatic applications for adults. Unlike somatic oximetry solutions that are indicated only for trending measurement, O3 with absolute rSO2 offers clinicians greater confidence that displayed values correlate with tissue oxygenation.
O3 regional oximetry continuously monitors the oxygen saturation of hemoglobin in the tissue under the sensor – whether in the brain or another tissue – with absolute accuracy specifications of 5% ARMS* (adult somatic, pediatric cerebral) and 4% ARMS (adult cerebral) and a trending specification of 3% ARMS (cerebral and somatic, all ages) through the use of O3 multi-wavelength sensors and O3 near-infrared spectroscopy (NIRS) technology. Unlike peripheral pulse oximetry, which reflects the body’s general arterial blood oxygenation, O3 provides information about the hemoglobin oxygen saturation in local tissue, whether cerebral or somatic tissue. The absolute accuracy specifications were validated by comparing O3 rSO2 values to arterial and venous saturation values obtained via blood draw. With the clearance for absolute accuracy of somatic rSO2, clinicians can now monitor not only the direction of changes in a specific tissue’s level of oxygen saturation (whether rSO2 is rising or falling) but also an rSO2 value established through comparison to a blood reference – information that may provide additional insight into a patient’s local oxygenation during various surgeries.
Monitoring both brain and somatic tissue oxygenation simultaneously has been found to further improve clinicians’ ability to provide rapid and accurate care. André Denault, MD, PhD, Department of Anesthesiology, Critical Care Program at the Montreal Heart Institute and Central Hospital of the University of Montreal, said, “There is a growing interest in the use of somatic NIRS owing to the association of cerebral and somatic desaturation with unfavorable outcomes in shock states. As an addition to O3 cerebral oximetry, the somatic component could serve as an earlier warning of impaired tissue perfusion. Somatic NIRS has been validated as a monitor of peripheral perfusion and shows an excellent correlation with peripheral perfusion compared with radionuclide plethysmography. As previously reported, cerebral and somatic NIRS combined with bedside whole-body ultrasound can help in early detection of different types of shock to formulate proper therapeutic strategies.”
O3 seamlessly integrates with the Root® Patient Monitoring and Connectivity Platform, a powerful, expandable monitor that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3, SedLine, and other measurements, such as SET® Measure-through Motion and Low Perfusion™ pulse oximetry, providing clinicians with expanded visibility of oxygenation status. Additional modalities available on Root include advanced rainbow® noninvasive measurements such as total hemoglobin (SpHb®) and PVi® (an indicator of fluid responsiveness), NomoLine® capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with the Masimo Hospital Automation™ platform, monitoring data from O3 can be automatically charted in electronic medical records (EMRs). The O3 module is also available through the integration into OEM partner monitors.