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Study Evaluates Utility of Masimo SpHb® During High-Blood-Loss Oncosurgery

MASI | August 28, 2017

Study Evaluates Utility of Masimo SpHb ^® During High-Blood-Loss Oncosurgery

Masimo (NASDAQ:MASI) announced today the findings of a recently published study in which researchers in New Delhi, India evaluated the utility of Masimo SpHb^®, noninvasive, continuous hemoglobin measurement, during oncosurgery on patients with high anticipated blood loss.¹

In the study, Dr. Gupta and colleagues sought to evaluate the utility of SpHb measurements on patients undergoing oncosurgery because oncosurgeries “may be associated with large blood loss, requiring repeated haemoglobin estimation for deciding the need for intraoperative blood transfusion.” They enrolled 50 adult patients with anticipated blood loss of at least 20%. During surgery, the patients’ SpHb was continuously monitored using a Masimo Radical-7^® Pulse CO-Oximeter^®. The researchers obtained venous blood samples, which were analyzed using a Beckman Coulter analyzer (LabHb), at the following points: immediately after induction, when approximately 500 ml of blood loss was suspected, and just before reversal of the neuromuscular blockade.

A total of 137 paired (SpHb and LabHb) data points were recorded for final analysis, including 66 at which packed red blood cell transfusions were made. The accuracy of SpHb in comparison to LabHb was assessed using Bland-Altman analysis. The level of agreement between SpHb and LabHb for the 66 transfusion data points showed a 73% correlation (p < 0.001), bias of -0.313 g/dL with standard deviation of ± 1.06 g/dL, and limits of agreement of -2.44 g/dL and 1.81 g/dL. The level of agreement between SpHb and LabHb for all 137 data points showed a 72.7% correlation (p < 0.001), bias of -0.376 g/dL with standard deviation of ± 1.27 g/dL, and limits of agreement of -2.92 g/dL and 2.16 g/dL.

The researchers concluded that, “Continuous SpHb monitoring can aid us regarding early blood transfusion decisions in oncosurgical patients along with other measures such as clinical judgement by attending consultant and haemodynamic variables. It may improve the intraoperative management of oncosurgeries by helping in real time and continuous decision-making for blood transfusion.” They also noted that SpHb “allows the physician to focus on the haemoglobin trend and detect either a slow decrease or a significant rapid drop in haemoglobin and therefore decide the appropriate time to perform an invasive measurement of haemoglobin.”

As limitations, the researchers stated that they “collected venous blood sample from central venous line rather [than] arterial blood. Haemoglobin concentration has been reported to be higher in venous blood than arterial blood though precision for haemoglobin estimation is higher for venous blood.” In addition, they suggested that further research may be needed to assess the effect of colloid administration and skin temperature at the probe site on SpHb accuracy, as well as its accuracy on patients with blood loss rates differing from the “massive but steady” rates observed in this study.

SpHb monitoring is not intended to replace laboratory blood testing. Blood samples should be analyzed by laboratory instruments prior to clinical decision making.

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Reference

Gupta N, Kulkami A, Bhargava AK, Prakash A, and Gupta N. Utility of noninvasive haemoglobin monitoring in oncosurgery patients. Indian Jour Anesth. July 2017; Volume 61; Issue 7; 543-548.

About Masimo

Masimo (NASDAQ:MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.⁷ 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^®), and more recently, Oxygen Reserve Index^™ (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

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.
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;338.
Taenzer AH 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 AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath SP 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.
Estimate: Masimo data on file.
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 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^®. 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, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.