IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today that in a new study using the 1st Generation Masimo Pronto® Pulse CO-Oximeter®, which noninvasively measures total hemoglobin (SpHb®), researchers found that noninvasive and invasive measurements correlated well and that “[g]iven the rapid availability of results and the lack of requirement of venipuncture, noninvasive hemoglobin monitoring may be a valuable adjunct in the initial evaluation and monitoring of pediatric trauma patients.”1
Pronto features rainbow SET™ technology, allowing for the noninvasive spot checking of SpHb, oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).
In the study, published online in the Journal of Trauma and Acute Care Surgery and conducted at the University of Tennessee Health Science Center, Le Bonheur Children’s Hospital, Dr. Mark Ryan and colleagues evaluated noninvasive SpHb measurement accuracy relative to current invasive and point-of-care testing in pediatric trauma patients. They performed a prospective observational trial involving 114 patients under age 17, measuring hemoglobin levels with a point-of-care device (i-STAT) and a lab analyzer (Sysmex XN Series). Noninvasive hemoglobin measurement, using 1st Generation Pronto, was performed within 15 minutes of phlebotomy.
Of the 114 patients, SpHb was successfully measured 89% of the time. Mean lab hemoglobin was 12.6 ± 1.9 and mean SpHb was 12.3 ± 1.6 (mean point-of-care hemoglobin was 12.2 ± 2.0). Bland-Altman analysis showed the limits of agreement between lab hemoglobin and non-invasive SpHb to be -2.9 and 1.9, with a mean difference of -0.49.
The researchers concluded that they were able to demonstrate “low bias and strong correlation between hemoglobin measurements using a noninvasive monitor, a point-of-care testing device, and laboratory co-oximeter in pediatric trauma patients.” They noted that noninvasive SpHb testing “may be most effective in determining when invasive testing of hemoglobin is warranted.”
Key limitations to the study include: the majority of the hemoglobin values measured were within normal limits; limited data on injury severity, morbidity, and mortality to understand their effects on device accuracy and precision; data is based on a convenience sample depending on availability of certified personnel; and no assessment on the effects of pre-hospital administration of intravenous fluids.
The researchers noted that “[f]urther study is required to determine the clinical utility of the [Pronto] device during the initial assessment and its accuracy in evaluating hemoglobin levels in hemodynamically unstable patients.” They stated that SpHb measurements should not be relied upon alone to determine active hemorrhage or the need for transfusion, and suggested the following reasons a noninvasive measurement could not be taken in 11% of the study’s participants: severe anemia; patients who were normotensive but tachycardic; patients unreadable due to the presence of nail polish; and cold extremities or low signal IQ without hemodynamic instability or anemia.
The University of Tennessee Health Science Center received equipment from Masimo to support the data collection for this study.
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- Ryan, Maxwell, Manning, Jacobs, Bachier-Rodriguez, Felizm, and Williams. “Noninvasive hemoglobin measurement in pediatric trauma patients.” Journal of Trauma and Acute Care Surgery. DOI: 10.1097/TA.0000000000001160. E-published ahead of print.
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 by taking noninvasive monitoring to new sites and applications. 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® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 Pronto® Pulse CO-Oximeter with 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 Pronto Pulse CO-Oximeter with SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.