Revolutionary Study Tests Accuracy of Masimo SpHb® Noninvasive Hemoglobin Monitoring During Elective Cesarean Section

Masimo SpHb has been shown to measure hemoglobin levels with “clinically acceptable accuracy” – even at the lowest levels. This breakthrough technology offers reliable and accurate readings, making it an invaluable tool for medical professionals.

Dr. Mohamed Ibrahim Beleta and colleagues at Cairo University recently published a study in the Egyptian Journal of Anesthesia, which evaluated the accuracy of Masimo SpHb®—a noninvasive, continuous hemoglobin monitoring device—on patients undergoing elective cesearan section (CS) with antepartum hemorrhage. The findings revealed significant positive correlations between SpHb and invasive hemoglobin (Hb) values, supporting the conclusion that SpHb is an accurate and reliable method for measuring hemoglobin levels in this population, even at low hemoglobin levels.

The researchers sought to evaluate whether the use of noninvasive, continuous hemoglobin monitoring might improve perioperative transfusion practices, allow patient condition to be assessed more quickly, and potentially reduce needless transfusions. To this end, they enrolled 60 pregnant women, aged 18-45, scheduled for elective cesarean section under general anesthesia. All of these women had experienced antepartum hemorrhage and were candidates for blood transfusion. During the procedure, the patients were monitored using both hospital standards and Masimo SpHb. Moreover, all blood samples were analyzed using the same Coulter laboratory analyzer to reduce variance. The Lab Hb and SpHb values were recorded before induction of anesthesia, before transfusion, and after transfusion. Blood transfusion was only carried out when Lab Hb decreased by more than 20% from the baseline.

The researchers compared SpHb and invasive Hb values at three points of comparison: baseline, pre-transfusion, and post-transfusion. They found a strong positive correlation between the two measures at all three points (r = 0.946, 0.902, and 0.698, respectively) with insignificant differences (p = 0.196, p = 0.092, and p = 0.570, respectively). Bland-Altman analysis revealed low bias and moderate limits of agreement for all three measurements: 0.348 g/dL (-0.584 and 1.280) at baseline, 0.314 g/dL (-0.561 and 1.188) at pre-transfusion, and 0.348 g/dL (-0.584 and 1.280) at post-transfusion.

The investigators concluded that Continuous SpHb Masimo Pulse CO-Oximetry provides a clinically reliable Hb calculation in comparison to Invasive Hb, even in patients with low hemoglobin undergoing CS. However, further research is needed with a larger sample size and multiple centers to fully assess the technique’s efficacy. Additionally, they recommended examination of this method in patients with common comorbidities such as hypertension, diabetes, and high cholesterol.

The evaluation of SpHb has the potential to bring a host of benefits to the healthcare setting, such as increased patient comfort, enhanced safety, and a simpler process for healthcare staff who are no longer exposed to the dangers of needle-stick injury and bloodspill contamination. By taking advantage of this innovative technology, healthcare workers can better protect themselves and their patients.

SpHb technology should not be seen as a replacement for laboratory blood testing, but rather as an additional tool to support the clinician’s decision-making when it comes to red blood cell transfusions. Taking into account patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples, clinicians can make informed decisions about the best course of action for their patients.

About Masimo

Masimo is a leading medical technology company that is dedicated to improving life, patient outcomes, and reducing healthcare costs. Their innovative measurements, sensors, patient monitors, and automation and connectivity solutions have been proven in over 100 independent and objective studies to outperform other pulse oximetry technologies. Masimo SET® has also been proven to help reduce severe retinopathy of prematurity in newborns, improve CCHD screening, and reduce rapid response team activations and costs. Masimo also offers a variety of other monitoring technologies and solutions, such as their rainbow® Pulse CO-Oximetry, Root® Patient Monitoring and Connectivity Platform, and their Radius Tº® and Masimo W1™ health and wellness solutions. Masimo is used in 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll, and is estimated to be used on more than 200 million patients worldwide.

The RPVi, ORi, and Radius VSM are revolutionary medical systems that have yet to receive FDA 510(k) clearance and are, as a result, not available for sale in the United States. However, these systems, which are all trademarked under Patient SafetyNet, are revolutionizing the medical industry by providing unprecedented levels of safety and security.

Forward-Looking Statements

At Masimo, we are dedicated to providing the best solutions to improve patient safety and clinical outcomes. Our technology, including Masimo SpHb®, is designed to be reliable and effective. Of course, no solution comes without risks and uncertainties, and we must take into account various factors such as the potential impact of COVID-19 and the accuracy of our findings. Although we are highly optimistic of the potential of our technology, we must remain cautious and take necessary steps to ensure we are meeting our goals.

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