Masimo (NASDAQ: MASI) announced today the findings of an
abstract recently presented at Euroanaesthesia 2020 in which Dr.
Saraçoğlu and colleagues at Marmara University in Istanbul, Turkey
investigated the efficacy of Masimo noninvasive and continuous
hemoglobin monitoring, SpHb®, as part of the transfusion management
of pediatric patients undergoing major surgery.1 The researchers
found that use of SpHb was associated with decreased rate of
postoperative transfusion, reduced length of ICU stay, and other
improved outcomes.
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Masimo Root® with SpHb® (Photo: Business
Wire)
Noting that traditional methods of measuring hemoglobin and
estimating blood loss as part of perioperative blood transfusion
management are “time consuming” and may cause delays in decision
making, the researchers sought to investigate whether use of a
noninvasive, continuous method, Masimo SpHb, would have an impact
on transfusion rates, morbidity, and mortality in pediatric
patients undergoing craniosynostosis surgery. Pediatric patients
aged 2-24 months were divided into a control group (n = 28), whose
transfusion therapy was managed using intermittent blood gas
analysis, and an experimental group (n = 27), whose transfusion
therapy was managed using SpHb monitored with Masimo rainbow®
sensors connected to a Radical-7® Pulse CO-Oximeter®. In both
groups, blood gas analysis was performed hourly during the
perioperative period; in the SpHb group, when SpHb monitoring
indicated a sudden decrease in hemoglobin, blood gas analysis was
simultaneously performed.
The researchers calculated the following statistically
significant (p < 0.05) results:
Outcome
Control Group
SpHb Group
P-value
Length of stay in ICU
55.43 hours ± 25.34 hours (48 hours
median)
33.48 hours ± 12.25 hours (24 hours
median)
0.001
Postoperative drainage
215.54 mL ± 93.1 mL
136.85 mL ± 62.27 mL
0.001
Postoperative red blood cell
transfusion
179.02 mL ± 163.06 mL (145 mL)
102.69 mL ± 73.87 mL (105 mL)
0.033
Postoperative fresh frozen plasma
transfusion
71.96 mL ± 94.95 mL (25 mL)
28.15 mL ± 64.35 mL (0 mL)
0.043
Perioperative crystalloid
396.79 mL ± 171.16 mL (350 mL)
462.59 mL ± 158.91 mL (500 mL)
0.048
First platelet level in ICU
270,821 ± 74,474
327,185 ± 104,644
0.025
Last lactate level in ICU
1.47 mmol/L ± 0.64 mmol/L (1.25
mmol/L)
1.18 mmol/L ± 0.63 mmol/L (0.9 mmol/L)
0.044
They found that the length of stay in the ICU was statistically
significantly higher in the control group than the SpHb group.
Postoperative drainage, red blood cell transfusion, and fresh
frozen plasma transfusion in the ICU were also statistically
significantly higher in the control group than the SpHb group.
Lactate levels were higher in the SpHb group at the start of the
operation, but higher in the control group at the end.
The researchers concluded, “Noninvasive continuous hemoglobin
monitoring in major hemorrhagic surgeries in pediatric patients
might be effective in reducing morbidity not only by reducing the
amount of transfusion but also [by] leading to less metabolic and
hemodynamic instability.”
In other clinical studies, conducted with adult patients,
continuous monitoring with SpHb as part of patient blood management
(PBM) programs has been found to improve outcomes, such as reducing
the percentage of patients receiving transfusions,2 reducing the
units of red blood cells transfused per patient,3-4 reducing the
time to transfusion,5 reducing costs,6 and even reducing mortality
30 and 90 days after surgery by 33% and 29%, respectively.7 The
evidence of SpHb’s impact on outcomes spans the globe, representing
6 countries on 4 different continents.2-8 Today, SpHb technology
supports clinicians in over 75 countries around the world.9
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, continuous SpHb monitoring, and laboratory
diagnostic tests using blood samples.
@Masimo | #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.10 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,11 improve CCHD screening in newborns,12 and, when used
for continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs13-16 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,17 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.18 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
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and
Masimo SafetyNet™. 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
- Saraçoğlu A , Orhon Ergün M, Sakar M, Uyar E, Saçak B, Aykaç Z.
The use of SpHb in pediatric patients undergoing major surgery
associated with reduced morbidity. Proceedings from the
Euroanaesthesia 2020 Annual Meeting. #5291.
- Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin
Monitoring during Orthopedic 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.
- Imaizumi et al. Continuous and noninvasive hemoglobin
monitoring may reduce excessive intraoperative RBC transfusion.
Proceedings from the 16th World Congress of Anaesthesiologists,
Hong Kong. Abstract #PR607.
- Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin
Monitoring in Intraoperative Blood Transfusion Practice During
Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
- Ribed-Sánchez B et al. Economic Analysis of the Reduction of
Blood Transfusions during Surgical Procedures While Continuous
Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367;
doi:10.3390/s18051367.
- Cros J et al. Continuous hemoglobin and plethysmography
variability index monitoring can modify blood transfusion practice
and is associated with lower mortality. J Clin Monit Comp. 3 Aug
2019. https://doi.org/10.1007/s10877-019-00367-z.
- Merolle L et al. Postoperative patient blood management:
transfusion appropriateness in cancer patients. Blood Transfus
2020; 18: 359-65 DOI 10.2450/2020.0048-20.
- Masimo data on file.
- 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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; risks related to
COVID-19; 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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