Masimo (Nasdaq: MASI) announced today that a new clinical study demonstrating the clinical accuracy of its noninvasive and continuous hemoglobin (SpHb®) monitoring technology breakthrough was presented last week at the Society for Technology in Anesthesia (STA) Annual Meeting.
The study, presented by the Johns Hopkins School of Medicine, evaluated the accuracy of Masimo SpHb—a noninvasive measurement of hemoglobin blood levels obtained using a Masimo Radical-7® Pulse CO-Oximeter™ with a Masimo rainbow® ReSposable Sensor. SpHb measurements obtained from 28 patients undergoing complex spine surgeries were compared with invasive blood samples drawn simultaneously and analyzed by a central laboratory. Results showed a mean bias of -0.3 for SpHb, a standard deviation of 1.0 g/dL and limits of agreement from -2.3 to 1.8 g/dL—demonstrating the "clinically acceptable accuracy" of SpHb when compared to a standard laboratory reference device. Researchers concluded that "continuous noninvasive SpHb monitoring may lead to earlier intervention and improved patient safety and care in the OR setting."
According to lead researcher, Lauren Berkow, MD, Associate Professor of Anesthesiology and Critical Care Medicine at the Johns Hopkins School of Medicine, "The Masimo noninvasive hemoglobin monitor correlated strongly with gold-standard laboratory hemoglobin even during significant blood loss. The ability to continuously monitor hemoglobin during complex spine surgery may allow for earlier diagnosis and treatment of anemia related to surgical bleeding as well as prevent over-transfusion."
Traditional blood analysis has many drawbacks, including complexity, time-consuming turnaround times that can impact clinical decisions, and blood loss due to invasive blood draws that have been found to contribute substantially to the anemic conditions that commonly occur in critically ill patients—thereby increasing transfusion rates. Published studies have shown that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery. These studies also suggest that transfusions and their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions.
The ability to noninvasively and continuously trend a patient's hemoglobin blood level during surgery allows for constant assessment of a patient's hemoglobin status, which may enable more appropriate clinical decisions—offering a breakthrough in blood management and patient safety that has the potential to improve patient outcomes, reduce patient exposure to unnecessary blood transfusions, and preserve precious blood resources.
According to Dr. Michael O'Reilly, Chief Medical Officer at Masimo, "Every surgical procedure bears certain risks—some may be preventable while others are unavoidable. Masimo SpHb fundamentally changes the way clinicians respond to bleeding and a patient's need for a blood transfusion by reducing measurement delays through real-time tracking and trending of hemoglobin blood levels. This study further underscores the value and impact of SpHb as a cost-effective solution to more accurately, easily, and rapidly monitor hemoglobin."
SpHb is available as part of the Masimo rainbow® SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), and acoustic respiration rate (RRa™), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).
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