New Study Evaluates Ability of Masimo SpHb® (Noninvasive Hemoglobin) to Estimate Timing for Invasive Measurement to Detect A...
May 20 2019 - 3:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today the results of a
study published in BMC Anesthesiology in which clinicians at Peking
Union Medical College in Beijing evaluated the ability of
noninvasive and continuous hemoglobin monitoring with Masimo SpHb®
to help clincians estimate when to conduct invasive hemoglobin
measurement to detect possible anemia in patients undergoing spine
or cytoreductive surgery.1
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Masimo Radical-7® with SpHb® (Photo:
Business Wire)
Noting that because of the “invasive, time-consuming and
intermittent” nature of invasive blood sampling, clincians often
forgo these “objective indications” when making transfusion
decisions during surgery, Dr. Tang and colleagues sought to
determine whether noninvasive, continuous hemoglobin monitoring
could aid clinicians in estimating when it might be appropriate to
perform an invasive measurement. They enrolled 69 adult patients
scheduled for spine surgery or cytoreductive surgery for whom
estimated blood loss was more than 15% of total blood volume. The
patients were randomly divided into an SpHb group (32 patients) and
a standard care group (37 patients). In the SpHb group, diagnostic
blood samples were drawn when a patient’s SpHb, measured using a
Masimo Radical-7® Pulse CO-Oximeter®, decreased by 1 g/dL. In the
standard care group, they were drawn at the clinicians’ discretion.
Blood gas analysis was performed using a Radiometer ABL800. The
researchers determined the positive predictive value (PPV) of SpHb
for the SpHb group and clinician perception in the standard care
group in detecting a decrease in lab hemoglobin of more than 1 g/dL
or lab hemoglobin of less than 10 g/dL.
The researchers found that the incidence of unnecessary
hemoglobin measurement was lower in the SpHb group than the
standard care group. For a decrease of greater than 1 g/dL in lab
hemoglobin, SpHb had a PPV of 93.3%, compared to 54.5% for clinical
perception (p = 0.002). For hemoglobin lower than 10 g/dL, SpHb had
a PPV of 86.7%, compared to 50.0% for clinical perception (p =
0.015). In the SpHb group, lab hemoglobin was never less than 7
g/dL. In addition, using Bland-Altman analysis, the researchers
calculated that, compared to lab hemoglobin, SpHb had bias and
precision of -0.29 +/- 1.03 g/dL, with limits of agreement of -2.30
and 1.72 g/dL. No difference was observed in transfusion units or
postoperative hemoglobin concentrations between the two groups.
The researchers concluded, “The SpHb trend tracked changes in
hemoglobin satisfactorily during surgery and more accurately
estimated the appropriate timing for invasive hemoglobin
measurements than the clinicians.” They also noted that “This study
was the first diagnostic randomized controlled trial to explore the
triage role of Pulse CO-Oximetry in the intraoperative detection of
anemia. We found that the trend in SpHb could detect a decrease in
Hb in dynamic situations and indicate the appropriate timing for
further Hb measurements.”
@MasimoInnovates | #Masimo
SpHb monitoring 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.
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®,
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
- Tang Bo, Yu X, Xu L, Zhu A, Zhang Y,
and Huang Y. Continuous noninvasive hemoglobin monitoring estimates
timing for detecting anemia better than clinicians: a randomized
controlled trial. BMC Anesthesiology. 17 May 2019.
https://doi.org/10.1186/s12871-019-0755-1
- 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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MasimoEvan Lamb949-396-3376elamb@masimo.com
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