New Prospective Study Finds That Masimo SpHb® Noninvasive and Continuous Hemoglobin Monitoring Can Help Provide Effective Blood Management in Patients Undergoing Major Surgery
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Masimo Root® with SpHb® and PVi® (Photo: Business Wire)
Noting that delayed or unnecessary blood transfusions have been associated with increased mortality and morbidity, the researchers sought to evaluate the impact of continuous hemoglobin monitoring with Masimo SpHb, which offers continuous trending of hemoglobin levels, provided noninvasively and in real time.The researchers enrolled 120 patients aged 18-85 (ASA score I-III) scheduled for major surgery, divided randomly into an SpHb group (n=60) and a control group (n=60). There were no significant differences in the demographics or mean arterial pressure, heart rate, or arterial blood gas analysis between the groups. In the control group, patients’ hemoglobin was measured using conventional, intermittent blood sampling, analyzed with an ABL800Flex Radiometer, at the beginning, the second hour, the fourth hour, and the end of the operation. In the SpHb group, in addition to conventional blood sampling, patients’ SpHb values, pleth variability index (Masimo PVi®) and perfusion index (Pi) were noninvasively and continuously monitored with Masimo Radical-7® Pulse CO-Oximeters®; in the case of a sudden decrease in hemoglobin value, an additional blood gas analysis was performed. In both groups, transfusion was carried out when hemoglobin levels fell below 9 g/dL (per standard
The researchers found that, comparing overall postoperative measurements, there were no significant differences between the groups in hemoglobin, platelet, or creatinine levels; nor in the amount of fresh frozen plasma, or platelet suspension transfused intraoperatively and postoperatively; nor in the amount of RBC units transfused intraoperatively. However, the postoperative RBC transfusion rate in the SpHb group was significantly lower (SpHb group: median 0 international units (IUs); control group: median 2 IUs; p=0.020).* Postoperative hemoglobin levels in SpHb group patients in the ICU were also statistically significantly higher (SpHb group: 8.41 g/dL ± 1.08 g/dL; control group: 7.75 g/dL ± 1.19 g/dL; p=0.033).
The investigators concluded, “SpHb measurement in major surgical cases can accompany conventional Hb measurement methods, allowing effective patient blood management practice. … Since this may decrease mortality and morbidity by reducing postoperative blood transfusion, the use of such an advanced monitoring method in major surgeries may increase patient safety.”
This study adds additional evidence to the growing literature on the value of continuous hemoglobin monitoring with SpHb. SpHb, as part of patient blood management programs, has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,2,3 reducing the units of red blood cells transfused per patient,4-6 reducing the time to transfusion,7 reducing costs,8 and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi®).9 This evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.1-9 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.
SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
*The transfusion rate data were provided by the authors after study publication and are included here with their permission.
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Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.10 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,11 improve CCHD screening in newborns,12 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.13-16 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,17 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23
ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in
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- Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
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- Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation.
The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
- McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
- Estimate: Masimo data on file.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®, Masimo PVi®, and Masimo Radical-7® Pulse CO-Oximeters®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, Masimo PVi, and Masimo Radical-7 Pulse CO-Oximeters, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the