New Published Study Demonstrates the Accuracy of Masimo Noninvasive and Continuous Hemoglobin Monitoring in Patients in Surgery and Intensive Care
IRVINE, Calif., May 16, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that findings from a new study published in the American Journal of Surgery demonstrate that noninvasive and continuous hemoglobin (SpHb®) monitoring correlates strongly with invasive laboratory hemoglobin testing and "can be beneficial in the operating room and critical care setting and may potentially decrease the invasiveness of both elective surgery and critical illness."(1) This is the first study to examine the accuracy and reliability of Masimo SpHb for measuring hemoglobin and hemorrhage in both the operating room and intensive care unit (ICU).
Total hemoglobin measurement is one of the most frequently ordered laboratory tests. However, hemoglobin levels must be obtained through blood draws that are invasive, time-consuming, and can only provide data at one point in time. Since the introduction of pulse oximetry, monitoring of blood oxygenation in the operating room has become a standard of care. Today with the Masimo rainbow SET® platform, clinicians now have access to noninvasive and continuous pulse oximetry along with SpHb and other blood constituent parameters— all in one device and from one sensor.
In the study, conducted at Madigan Army Medical Center in Tacoma, Washington, researchers compared noninvasive SpHb and invasive laboratory measurements in a series of patients undergoing major surgical procedures in the operating room or with severe illnesses in the ICU. Using the Radical-7® Pulse CO-Oximeter, measurements were obtained on 25 elective surgical patients in the operating room and 45 critically ill patients in the ICU and compared to hemoglobin measurements obtained invasively every hour from the radial artery catheter. A total of 27 point-of-care invasive hemoglobin measurements (iStat® from Abbott) were also collected. Significant bleeding was identified in 44% of the surgical patients.
Results showed an overall correlation between SpHb and lab values of 0.78 (P<.001) with a mean difference of 0.15 g/dL (95% confidence interval, -0.03 to 0.32 g/dL). In the OR, the mean difference was 0.29 g/dL (95% confidence interval, 0.09 to 0.50g/dL) while in the ICU, the mean difference was 0.05 g/dL (95% confidence interval, 0.22 to 0.31 g/dL). In the five patients requiring intra-operative blood transfusion, there was a very strong correlation of 0.91 between SpHb and lab measurements. When the point-of-care measurements from iStat were compared to lab measurements, the results were similar to SpHb comparisons to lab measurements, with a correlation of 0.85 and a mean difference of 0.09 g/dL (95% confidence interval 0.17 to 0.34 g/dL).
As a result of these findings, researchers deemed that "noninvasive hemoglobin monitoring is especially important" for high-risk critically ill patients or patients undergoing high-risk operations, critically ill bleeding/transfused patients or patients undergoing operations with an expected high blood loss, and for patients not expected to have significant bleeding intra-operatively but in whom obtaining laboratory values would be difficult or impossible if not pre-planned.
Commenting that SpHb monitoring "will benefit the patient, intensivist, and anesthesiologist by allowing continuous physiological monitoring without having to occlude the arterial line and may even preclude the need for a central line when the purpose is only for frequent laboratory hemoglobin analysis," researchers concluded that "based on the strong correlation between SpHb and laboratory hemoglobin, noninvasive hemoglobin monitoring can be beneficial in the operating room and critical care setting and may potentially decrease the invasiveness of both elective surgery and critical illness while providing continuous hemoglobin monitoring in addition to standard pulse oximetry data."
SpHb is available as part of Masimo rainbow SET® platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), perfusion index (PI), and acoustic respiration rate (RRa™), in addition to the 'gold standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), and pulse rate (PR).
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.
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 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 SpHb is capable of providing continuous physiological monitoring of hemoglobin levels in all surgical or critically ill patients, and risks related to our assumptions that Masimo SpHb monitoring has the potential to decrease the invasiveness of elective surgery and critical illness, 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.
(1) Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. "Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station." Am J Surgery 2011: 201: 590-596. Available online here.
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