SOURCE: Masimo

Masimo

November 05, 2014 08:01 ET

New Clinical Study Shows Accuracy of Masimo Noninvasive Spot-Check Hemoglobin (SpHb®) in Trauma Patients

IRVINE, CA--(Marketwired - Nov 5, 2014) - Masimo (NASDAQ: MASI) announced today that a new clinical study published in the Journal of the American College of Surgeons showed that noninvasive spot-check hemoglobin (SpHb) measurements had good correlation with invasive laboratory hemoglobin measurements in trauma patients with the potential to speed clinical decision-making to improve care, patient safety, and cost of care.1

Hemoglobin is one of the most frequently ordered laboratory tests in trauma settings.2 Although invasive measurements are considered the standard of care, limitations include collecting blood samples, transport of samples to the laboratory, analysis, and communication back to the physician who ordered the test -- all of which are time consuming steps and can delay patient assessment.3,4 Spot-check SpHb can supplement laboratory hemoglobin measurements by providing noninvasive and quick assessment of a patient's hemoglobin, along with oxygen saturation and pulse rate. 

At the University of Arizona's Department of Surgery, Division of Trauma, Critical Care and Emergency Surgery in Tucson, Ariz., Dr. Joseph and colleagues evaluated trauma patients who presented at a Level 1 Trauma Center. Noninvasive hemoglobin measurements using a Pronto-7 (version 2.1.9) were compared with invasive hemoglobin measurements from venous blood samples on a laboratory hematology analyzer (Siemens Medical Solutions Diagnostics, Zurich, Switzerland).

Noninvasive spot-check hemoglobin (SpHb) measurements were attempted on a total of 525 patients, with a success rate of 86% (n=450). SpHb was measured three times in each patient using the Masimo Pronto-7. The first measurement was obtained on presentation to the trauma unit while the second and third measurements were obtained at five-minute intervals, for a total of 1,350 spot-check SpHb measurements.

Of the 75 patients in which SpHb could not be measured, 36 had either nail polish, soot or tar on their fingers, 21 had difficulty with sensor fit as researchers had only one size sensor for this study, 10 had radiological interference due to external factors such as X-ray and ultrasound devices, and the remaining eight patients were either too anxious or agitated to record SpHb.

The study population's invasive hemoglobin was 11.5 ± 4.36 g/dL (Range 6 g/dL-16 g/dL) and the average SpHb was 11.1 ± 3.60 g/dL (Range 6.4 g/dL-16.3 g/dL). The bias and standard deviation of SpHb compared to invasive hemoglobin was 0.3 ± 1.3 g/dL. Thirty-eight percent (n=173) of the patients had invasive hemoglobin ≤ 8 g/dL on presentation; 12% (n=54) of patients received a blood transfusion and 8% (n=36) underwent emergency surgical intervention for bleeding.

Researchers stated: "After dichotomization of our patients into two groups, patient with hemoglobin ≤ 8 g/dL and patients with hemoglobin > 8 g/dL, spot-check hemoglobin measurements were found to have a sensitivity of 95.4% and an accuracy of 76%." Researchers also noted that "Noninvasive spot-check (hemoglobin) measurement has a strong correlation with the invasive hemoglobin measurements (ICC=0.70; CI: 0.57-0.80) and excellent correlation between the three consecutive noninvasive spot-check (hemoglobin) measurements (ICC=0.90; CI: 0.87-0.94)." 

The researchers also stated: "We conclude that this novel technology allows for immediate and accurate hemoglobin measurements in trauma patients," and "We believe this device has the potential to improve clinical care, patient safety, and the cost of care."

Pronto-7 is a monitoring device and is not intended to be used as a standalone diagnostic tool. SpHb measurements are intended to supplement invasive hemoglobin measurements and are not intended to replace them.

1 Joseph B, Pandit V, Aziz H, Kulvatunyou N, Zangbar B, Tang A, Keeffe TO', Jehangir Q, Snyder K, Rhee P. "Transforming Hemoglobin Measurement in Trauma Patients: Non- Invasive Spot Check Hemoglobin," Journal of the American College of Surgeons (2014), doi: 10.1016/j.jamcollsurg.2014.09.022.
2 Gehring H, Hornberger C, Dibbelt L, et al. Accuracy of point of care testing (POCT) for determining hemoglobin concentrations. Acta Anaesthesiol Scand. 2002; 46:980-86.
3 Mokken FC, van der Waart FJ, Henny CP, et al. Differences in peripheral arterial and venous hemorheologic parameters. Ann Hematol 1996; 73:135-137.
4 Yang ZW, Yang SH, Chen L, et al. Comparison of blood counts in venous, fingertip, and arterial blood and their measurement variation. Clin. Lab. Haem. 2001; 23:155-159.

About Masimo
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 help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. 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 commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be 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.

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 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 risks related to our assumptions regarding the repeatability of clinical results, risks related to assumptions that Masimo SpHb can accurately track and trend Hb changes in all patients, 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

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