Study Investigates the Ability of Masimo Noninvasive, Continuous Hemoglobin (SpHb®) to Provide Earlier Indication of Anemia ...
September 23 2019 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today that in a study published
in Injury, researchers used Masimo SpHb® – noninvasive, continuous
hemoglobin monitoring – to investigate possible delays in the
detection of perioperative anemia assessed using invasive,
intermittent laboratory hemoglobin values in elderly patients
undergoing hip fracture surgery.1 In addition, they investigated
associations between a) this delay and cumulative perioperative
time with anemia, monitored using SpHb, and b) patient outcomes
(postoperative delirium and mortality or severe complications).
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Masimo Radical-7® with SpHb® (Photo:
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Dr. Christopher G. Clemmesen and colleagues at Copenhagen
University Hospital in Denmark sought to investigate the impact of
anemia during surgery on patient outcomes – and whether noninvasive
hemoglobin monitoring using Masimo SpHb might provide an earlier
indication of perioperative anemia, as well as more effectively
track total time with perioperative anemia, than traditional,
intermittent invasive blood sampling. Data from 41 patients, aged
65 or older, undergoing surgery to repair hip fractures, were
analyzed. Blood samples were taken as per standard hospital
protocol, with transfusions triggered by a hemoglobin (Hb) value
below 10 g/dL, which was also used to define anemia. Throughout
surgery, SpHb, as well as oxygen saturation (SpO2), perfusion index
(Pi), and pulse rate (PR), were noninvasively monitored using
Masimo Radical-7® Pulse CO-Oximeters and rainbow® sensors. The
clinicians were blinded to data other than SpO2 to prevent them
from using SpHb or Pi values to guide transfusion or other clinical
decisions.
The researchers found a mean delay in the detection of anemia
(defined as the time lag between an SpHb value of 10 g/dL or less
and a similarly low Hb value obtained through blood sampling) of
1.07 hours (± 2.84 hours). They found a significant association
between median cumulative perioperative time with low SpHb (defined
as SpHb below 10 g/dL for at least one minute) and postoperative
delirium: 162 minutes for patients with delirium vs. 22 minutes for
patients without (p = 0.034).
The researchers concluded, “In conclusion, we found a delay in
transfusion threshold detection on average, and for some patients,
the delay was substantial despite the study being done in an
optimized perioperative setting in a specialized ward. Continuous
monitoring with SpHb during the perioperative period revealed that
some patients had Hb levels below the prescribed transfusion
threshold for a prolonged period. Furthermore, we found a
significant association between the presence of low SpHb and
postoperative outcomes, and between the cumulated time with low
SpHb and postoperative outcomes. ... Whether or not increased
monitoring translates into improved patient outcomes will require
further studies.”
Study co-author Dr. Nicolai B. Foss commented, “There can be a
significant delay in perioperative detection of anemia in hip
fracture patients, and the time spent anemic, as measured
continuously by SpHb, was associated with poor outcomes in our
study. We need continuous monitoring in order to identify and act
on anemia in a timely manner to improve patient outcomes. We
believe that future transfusion studies should include improved
perioperative monitoring of hemoglobin to help identify
anemia.”
SpHb is not intended to replace laboratory blood testing.
Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering among other factors:
patient condition and laboratory diagnostic tests using blood
samples.
@MasimoInnovates | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.2 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,3 improve CCHD screening in newborns,4 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.5-7 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,8 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S.
News and World Report Best Hospitals Honor Roll.9 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET™
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. 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®),
Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius PPG™, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97™. Masimo hospital
automation and connectivity solutions are centered around the Iris®
platform, and include Iris Gateway™, Patient SafetyNet, Replica™,
Halo ION™, UniView™, and Doctella™. Additional information about
Masimo and its products may be found at www.masimo.com. Published
clinical studies on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Clemmesen CG, Palm H, and Foss NB5. Delay in detection and
treatment of perioperative anemia in hip fracture surgery and its
impact on postoperative outcomes. Injury (2019).
https://doi.org/10.1016/j.injury.2019.09.001.
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- 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;Jan
8;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 A 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.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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®. 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, 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.
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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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