Company Website:
http://www.masimo.com
CHICAGO -- (Business Wire)
Masimo (NASDAQ:
MASI) announced today the findings of an abstract presented at the
American Society of Anesthesiologists’ (ASA) Annual Meeting in Chicago.
In the study, researchers at Hôpital Dupuytren, part of the Centre
Hospitalier Universitaire of Limoges, France (CHU Limoges), investigated
the clinical utility of noninvasive, continuous hemoglobin (SpHb®)
and PVI® (a measure of the dynamic changes in perfusion index
that occur during the respiratory cycle), two Masimo rainbow SET™
measurements. The researchers’ goal was to determine, at the scale of a
whole hospital, improvement in mortality and transfusion needs.1
In the prospective, single-center, observational study, Professor
Nathalie Nathan and colleagues reviewed two sets of patients over two
eleven-month periods, before (2013) and after (2014) implementation of a
clinical algorithm to guide transfusion and fluid administration.
Anesthesiologists, nurses, and residents were trained on the
implementation of the clinical algorithm. Masimo Radical-7®
Pulse CO-Oximeters® were installed in all operating rooms,
recovery rooms, and intensive care units. The Radical-7s were connected
to Masimo Patient SafetyNet™* for trend data collection. All surgical
patients presenting to the hospital were accepted, with these
exceptions: EMT, ophthalmology, odontology, radiology, neurosurgery, and
patients less than 18 years of age.
The study included 18,867 patients (in the two groups), of whom 3450
underwent SpHb and PVI monitoring via Radical-7. The patients in the
monitoring group received vascular filling with crystalloids or blood,
according to the clinical algorithm. Demographic, anesthesia, surgical,
and transfusion data were collected in electronic medical records. The
researchers compared the percentage of patients in the monitored group
who received transfusions within the first postoperative 48 hours to the
percentage in the non-monitored group. They also compared mortality
rates for each group at 30 days and 90 days following surgery.
Using the cox-proportional hazard model, the researchers found that the
patients in the group monitored with SpHb and PVI had a 30% reduction in
mortality at 30 days and a 25% reduction in mortality at 90 days. The
proportion of patients receiving transfusions did not change
significantly between the two groups (7.9% in 2013, 8.5% in 2014,
p=0.1323), nor did the number of blood units transfused within 48 hours
(3.4 ± 2.7 in 2013, 3.4 ± 2.0 in 2014, p>0.05). However, in non-cardiac
surgery, patients were transfused sooner in the operative or recovery
room (72.9% vs 56.1%, p=0.0002).
The researchers concluded that “Monitoring SpHb and PVI integrated in a
vascular filling algorithm allowed earlier transfusion and reduces
mortality at a scale of a whole hospital with different clinical
practices (and practitioners) and unselected patients.”
“Access to continuous monitoring of Hb levels and fluid responsiveness
has changed the way we address blood and fluid management. By lowering
inadequate fluid filling at the beginning of anesthesia, we are able to
avoid diluting patients inadequately and this data helps us to guide
precisely the amount of fluids or blood that must be given to patients
on a case by case basis,” stated Professor Nathan, Head of the
Department of Anesthesiology at CHU Limoges. “Patients are transfused
earlier when needed and hypovolemia is precisely treated with
crystalloid. These two facts may explain the decrease in mortality at
one and three months that we observed in this study. We strongly believe
that surgeries of intermediate severity such as hip or knee replacement
procedures as well as severe surgery will benefit from this technology.
Because it is easy to use, quick to administer, provides continuous
data, and does not harm the patient in any way, it is more applicable to
common clinical practice.”
Joe Kiani, Founder and CEO of Masimo, commented, “We have created
technologies that have been shown to save babies’ eyesight2,
screen for CCHD in newborns3, and reliably monitor patients
in post-surgical wards4,5,6, but this is the first time a
study has shown that one of our technologies has such a big impact on
mortality. Needless to say, we are excited and thank Dr. Nathan for her
and her colleagues’ research. We look forward to more studies like this
that investigate the impact of SpHb and PVI on other patients at other
hospitals, and hope to see similar results.”
SpHb monitoring may provide additional insight to the directional trend
of hemoglobin between invasive blood samplings – when the SpHb trend is
stable and the clinician may otherwise think hemoglobin is decreasing;
when the SpHb trend is rising and the clinician may otherwise think
hemoglobin is not rising fast enough; or when the SpHb trend is
decreasing and the clinician may otherwise think hemoglobin is stable.
SpHb monitoring, accompanied by laboratory diagnostic testing, may thus
help clinicians make more timely and informed decisions, and has been
shown to help clinicians provide more timely blood transfusions** and
reduce blood transfusions in cases such as neurosurgery and orthopedic
surgery.7,8
@MasimoInnovates |
#Masimo
*The use of the trademark SafetyNet is under license from University
HealthSystem Consortium.
**Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering, among other factors:
patient condition, continuous SpHb monitoring, and laboratory diagnostic
tests using blood samples.
References
-
Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
-
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.
-
Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring
during Orthopedia Surgery: A Randomized Trial. J Blood Disorders
Transf. 2014. 5:9. 2.
-
Awada WN et al. Continuous and noninvasive hemoglobin monitoring
reduces red blood cell transfusion during neurosurgery: a prospective
cohort study. J Clin Monit Comput. 2015 Feb 4.
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 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.
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® and PVI®. 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 and PVI, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161022005012/en/
Contacts:
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com
Source: Masimo
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