Study presented at the Society for Critical Care
Medicine's 2007 annual meeting concludes Masimo Blue sensor superior in
continuous and accurate pulse oximetry monitoring of cyanotic infants
with congenital heart disease
Irvine, California -March 6, 2007- Masimo, the
inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion
Pulse Oximetry, reported that an independent study presented at the
2007 Society for Critical Care Medicine (SCCM) Annual Meeting in
Orlando clearly demonstrated the superiority of Masimo LNOP Blue
Sensors in providing accurate, reliable and continuous pulse oximetry
readings in cyanotic infants with congenital heart disease. In the
study, the Masimo LNOP Blue sensor-which was specifically designed for
use in pediatric patients with low oxygen saturation-was compared to a
Nellcor OxiMax sensor and to a standard Masimo LNOP sensor not designed
for cyanotic patients, and was shown to have a "significantly higher
correlation to arterial blood gas in comparison to the two other
sensors studied." 1
The study was performed by a team of researchers from the Department
of Clinical Engineering and Anesthesiology at St. Mary's Hospital in
Fukuoka, Japan, who stated that it is extremely difficult to measure
low saturation values (<70%) with accuracy with a conventional pulse
oximeter. They explained that infants with congenital heart disease
(CHD) are often kept at low oxygen saturation levels in order to
maintain cardiac output and perfusion and that because of this, it is
especially important for clinicians to be able to accurately measure
their oxygen saturation by pulse oximeter.
To determine the accuracy of the Masimo Blue sensor with this
difficult patient population, researchers analyzed 45 arterial blood
gas samples received from six cyanotic infants undergoing pulmonary
artery banding procedures and compared pulse oximetry data with
arterial blood samples analyzed by CO-Oximetry. The results clearly
showed the Masimo LNOP Blue sensor delivered more accurate and reliable
readings, with a bias (indicating 95% limit agreement) and precision of
0.83 and 2.16 respectively, compared to 8.24 and 4.23 for the Nellcor
OxiMax and 7.83 and 4.57 for the standard LNOP. The root-mean-square-a
method of analyzing bias and precision-of these results shows that the
Masimo LNOP Blue sensor is four times more accurate than the other
sensors.
The researchers reported, "The LNOP Blue Sensor indicated
significantly higher correlation to arterial blood gas in comparison to
other two sensors studied. Therefore, LNOP Blue sensor can be a
solution for monitoring accurately low saturation levels.
Accurate non-invasive monitoring can reduce the number of arterial
blood gas draws and can also reduce the risk of infection related to
blood draws. The LNOP Blue Sensor provides for the accurate measurement
of pulse oximetry" when used on cyanotic infants with congenital heart
disease.
Joe E. Kiani, Chairman and CEO of Masimo stated, "We are happy to
see that researchers all around the world are recognizing and
validating the effectiveness of our LNOP Blue sensor with Masimo SET
technology in providing accurate, reliable and continuous pulse
oximetry readings in infants with congenital heart disease, enabling
clinicians to more effectively care for one of the most vulnerable
patient populations. With this study, there have now been a total of
five independent studies on the LNOP Blue sensor conducted in the
United States, Japan and Canada-all with similar results. At
Masimo, we take very seriously our legacy of developing technologies
that enable more advanced and comprehensive care for those patients who
are most at risk. We will continue to expand and deepen our technology
portfolio to provide a broad spectrum of noninvasive monitoring
parameters that help caring clinicians make better diagnostic and
treatment decisions across a wide range of patient populations."
1 Clinical evaluation of Accuracy of
Masimo LNOP Blue sensor in cyanotic infants: Yoshimitsu Tsutsumi,
Masakazu Nakashima, Takeshi Ifuku, Hiroshi Yasunaga M.D., Fumiya Nakao
M.D., Jun Takamatsu M.D. Department of Clinical Engineering and
Anesthesiology, St. Mary's Hospita, Fukuoka, Japan
-end-
About Masimo
Masimo develops innovative
monitoring technologies that significantly improve patient care-helping
solve "unsolvable" problems. In 1995, the company debuted Read-Through
Motion and Low Perfusion pulse oximetry, known as SET, and with it
virtually eliminated false alarms and increased pulse oximetry's
ability to detect life-threatening events. More than 100 independent
clinical studies have confirmed that Masimo SET technology allows
clinicians to accurately monitor blood oxygen saturation in critical
care situations-establishing the technology as the "gold standard"
pulse oximetry and substantially contributing to improved patient
outcomes. In 2005 Masimo introduced Masimo Rainbow SET Pulse
CO-Oximetry, which, for the first time, noninvasively monitors the
level of carbon monoxide and methemoglobin in the blood, allowing early
detection and treatment of potentially life-threatening conditions.
Masimo, founded in 1989, 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.
Contact:
Tom McCall, Masimo Corporation
Phone: 949-297-7075
Email: tmccall@masimo.com
Masimo, SET, Signal Extraction Technology,
Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing
Cost of Care by Taking Noninvasive Monitoring to New Sites and
Applications are registered trademarks of Masimo Corp. Rainbow, SpCO,
SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.