Masimo SpHb Demonstrated “Clinically Acceptable Accuracy” of Hemoglobin Measurement, Even at Low Hemoglobin Levels
NEUCHATEL, Switzerland, January 03, 2023–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the findings of a prospective study published within the Egyptian Journal of Anesthesia through which Dr. Mohamed Ibrahim Beleta and colleagues at Cairo University evaluated the accuracy of noninvasive, continuous hemoglobin monitoring with Masimo SpHb® on patients undergoing elective cesearan section (CS) with antepartum hemorrhage. The researchers found significant positive correlations between SpHb and invasive hemoglobin (Hb) values, and concluded, “In patients undergoing CS with antepartum hemorrhage, continuous SpHb through Masimo Pulse CO-Oximetry demonstrated clinically acceptable accuracy of Hb measurement compared with invasive Hb, even at low hemoglobin levels.”1
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Masimo Root® with SpHb® and PVi® (Photo: Business Wire)
The authors note that antepartum hemorrhage is related to opposed maternal and neonatal outcomes and that blood transfusion can be related to quite a lot of risks, but that invasive laboratory hemoglobin measurement, while a vital consider transfusion decisions, yields intermittent and sometimes delayed results. The researchers thus sought to judge whether use of noninvasive, continuous hemoglobin monitoring might “enable a more rapid detection of clinically significant blood loss, improve perioperative transfusion practices, allow patient condition to be assessed more quickly and blood management more adequately, and even perhaps reduce useless transfusions.” They enrolled 60 pregnant women, aged 18-45, scheduled for elective CS under general anesthesia between April 2016 and December 2017. All subjects had antepartum hemorrhage and were candidates for blood transfusion. Throughout the procedure, all patients were monitored as per hospital standards, and as well as, with Masimo SpHb. All blood samples (Lab Hb) were analyzed using the identical Coulter laboratory analyzer to avoid variance induced by means of multiple devices. Lab Hb and SpHb values were recorded before induction of anesthesia (baseline), before transfusion, and after transfusion. Blood transfusion was carried out when Lab Hb decreased by greater than 20% from baseline.
The researchers found significant positive correlations between SpHb and invasive Hb on the three points of comparison: baseline (r = 0.946), pre-transfusion (r = 0.902), and post-transfusion (r = 0.698). Differences at those times were insignificant: p = 0.196, p = 0.092, and p = 0.570, respectively. Using Bland-Altman evaluation, they found low bias and moderate limits of agreement: 0.348 g/dL (-0.584 and 1.280) at baseline measurement, 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, “Continuous SpHb Masimo Pulse CO-Oximetry shows an appropriate clinically reliable Hb calculation as compared to Invasive Hb even in patients undergoing CS with low hemoglobin. Further studies are needed on larger sample size with multicenter collaboration. Moreover, we recommend the assessment of this system on patients with common morbidities, corresponding to high cholesterol, hypertension, and diabetes.”
The researchers also noted that “SpHb evaluation has the potential for added advantages, including patient comfort, increased safety, and decreased complexity for healthcare staff, who should not exposed to the risks of needle-stick injury and bloodspill contamination.”
SpHb just isn’t intended to interchange laboratory blood testing. Clinical decisions regarding red blood cell transfusions ought to be based on the clinician’s judgment considering, amongst other aspects, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
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About Masimo
Masimo (NASDAQ: MASI) is a world medical technology company that develops and produces a wide selection of industry-leading monitoring technologies, including progressive measurements, sensors, patient monitors, and automation and connectivity solutions. As well as, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to enhance life, improve patient outcomes, and reduce the associated fee 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.2 Masimo SET® has also been shown to assist clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-8 Masimo SET® is estimated for use on greater than 200 million patients in leading hospitals and other healthcare settings all over the world,9 and is the first pulse oximetry at 9 of the highest 10 hospitals as ranked within the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the bottom as much as be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed to be used in quite a lot of clinical and non-clinical scenarios, including tetherless, wearable technology, corresponding to Radius-7®, Radius PPG®, and Radius VSM™, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available to be used each within the hospital and at home, corresponding to Rad-97®. Masimo hospital and residential automation and connectivity solutions are centered across the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius Tº® and the Masimo W1™ watch. Additional details about Masimo and its products could also be found at www.masimo.com. Published clinical studies on Masimo products may be found at www.masimo.com/evidence/featured-studies/feature/.
ORi, RPVi, and Radius VSM haven’t received FDA 510(k) clearance and should not available on the market in america. The usage of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
References
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Beleta MI, Abdallah SR, Hammad YM, Hossam EMY, Ali ABE, Mohamad AA, AbdElhameed BM. Noninvasie continuous hemoglobin monitoring of blood transfusion in obstetric procedures. Egyptian J Anesth. 2022, Vol. 38, No. 1, 701-708. https://doi.org/10.1080/11101849.2022.2153976.
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Published clinical studies on pulse oximetry and the advantages of Masimo SET® may be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies that are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
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Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
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de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
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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.
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Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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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.
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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.
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Estimate: Masimo data on file.
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http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
Forward-Looking Statements
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 reference to the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, amongst others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of that are difficult to predict and lots of of that are beyond our control and will cause our actual results to differ materially and adversely from those expressed in our forward-looking statements consequently of assorted risk aspects, 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, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings could also be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique benefits; risks related to COVID-19; in addition to other aspects discussed within the “Risk Aspects” section of our most up-to-date reports filed with the Securities and Exchange Commission (“SEC”), which could also be obtained at no cost on the SEC’s website at www.sec.gov. Although we consider that the expectations reflected in our forward-looking statements are reasonable, we have no idea whether our expectations will prove correct. All forward-looking statements included on this press release are expressly qualified of their entirety by the foregoing cautionary statements. You’re cautioned not to position undue reliance on these forward-looking statements, which speak only as of today’s date. We don’t undertake any obligation to update, amend or make clear these statements or the “Risk Aspects” contained in our most up-to-date reports filed with the SEC, whether consequently of recent information, future events or otherwise, except as could also be required under the applicable securities laws.
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Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
