Masimo (NASDAQ: MASI) announced today that in a study recently
published in Anesthesia & Analgesia, researchers evaluated the
ability of noninvasive and continuous hemoglobin monitoring with
Masimo SpHb® to detect the development of acute hemodilution after
graded fluid administration, by comparing it to invasively measured
laboratory hemoglobin (BHb), on patients undergoing major
surgery.1
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Masimo Root® with SpHb® and PVi® (Photo:
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In the study, Dr. Şerban Bubenek-Turconi and colleagues at the
Carol Davila University of Medicine and Pharmacy and the Prof. C.C.
Iliescu Institute for Cardiovascular Diseases in Bucharest,
Romania, and Sheba Medical Center in Tel Aviv, Israel, examined the
effects of incremental fluid loading (as part of perioperative
goal-directed therapy (GDT)) on oxygen delivery and whether
noninvasive SpHb monitoring could reliably track the development of
acute hemodilution (which can necessitate blood transfusions that
might otherwise be avoided). They analyzed data from 40 adult
patients undergoing major gastrointestinal or vascular surgery.
SpHb was continuously measured using Masimo Root® with the
Radical-7® Pulse CO-Oximeter®. BHb and partial pressure of oxygen
(PaO2) were intermittently, invasively measured using a Radiometer
ABL800 blood gas analyzer. Cardiac output (CO) and stroke volume
(SV) were also obtained through invasive modalities. Oxygen
delivery (DO2) was calculated as: CO*((Hb*1.38*SpO2)+PaO2*0.0031)).
Parameter values were recorded after the induction of general
anesthesia and before the start of surgery (T0) and 5 minutes after
successive 250 ml colloid fluid challenges (FC) (T1, T2, and T3).
Patients were given the second and third fluid challenges if at
each stage SV increased by at least 10%. 40 patients received the
first FC, 32 received the second, and 20 received the third, for a
total of 92 administered FCs.
The researchers found that, “Compared to their baseline values
(T0), BHb and SpHb decreased by a mean of 5.3% ± 4.9% and 4.4% ±
5.2%, respectively, after the first FC (T1; n = 40), by 9.7% ± 8.4%
and 7.9% ± 6.9% after the second FC (T2; n = 32), and by 14.5% ±
6.2% and 14.6% ± 5.7% after the third FC (T3; n = 20).” Using
Bland-Altman analysis of all 132 paired SpHb and BHb values, the
researchers found mean bias and precision values of -0.3 ± 1.5 g/dL
and limits of agreement of -2.7 to 3.3 g/dL. They also found that
concordance rates between changes in SpHb and in BHb after the
administration of the 250, 500, and 750 mL of fluid were 83%, 90%,
and 100%, respectively. They noted that results showed “excellent”
concordance after 750 mL, despite the limited absolute accuracy,
which may have been negatively affected by the “well-recognized
inherent variability of the laboratory Hb device that served as our
reference method.”
The researchers concluded, “In summary, our study shows that
acute iatrogenic hemodilution does invariably occur after fluid
administration, that it may lead to paradoxical decrease in DO2
especially in ‘nonresponders’ and that its development is made
visible by the continuous monitoring of SpHb when >500 mL of
colloids are being administered. Further studies are needed to
examine the potential clinical benefit of SpHb monitoring in
identifying acute hemodilution.”
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.
@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 2018-19 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
- Bubenek-Turconi S, Văleanu L, Popescu M, Panaitescu E, Tomescu
D, Cacoveanu M, and Perel A. Continuous Noninvasive Hemoglobin
Monitoring Reflects the Development of Acute Hemodilution After
Consecutive Fluid Challenges. Anesth Analg. 2019. DOI:
10.1213/ANE.0000000000004323.
- 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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Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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