NEUCHATEL, Switzerland-Tuesday 21 May 2019 [ AETOS Wire ]
(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
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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Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
