Study Finds Noninvasive, Continuous Masimo PVi® Monitoring More Valuable Than Central Venous Pressure Measurement for Guidin...
May 04 2020 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today the findings of a study
published in the Journal of Anesthesiology and Reanimation
Specialists’ Society in which researchers compared two methods of
intraoperative fluid management during orthopedic spinal surgery,
including Masimo PVi®. In comparison to invasive and intermittent
central venous pressure (CVP) measurement, noninvasive and
continuous pleth variability index (PVi) provided “better cardiac
stabilization with less fluid replacement, and more accurate
results in the evaluation of intravascular volume status.”1
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Masimo Radical-7® with PVi® (Photo:
Business Wire)
Dr. Eralp Çevikkalp and colleagues at Celal Bayar University in
Turkey, noting the importance of intraoperative fluid management
during surgery and the drawbacks of traditional invasive, static
fluid assessment methods such as CVP and mean arterial pressure
(MAP), investigated whether PVi might provide an effective
noninvasive and dynamic alternative. In a randomized, controlled
trial of 100 adult patients undergoing elective posterior lumbar
stabilization surgery, they compared fluid loading-induced changes
as guided by PVi and by CVP. The patients were divided into two
equally sized groups. In the PVi group, patients were continuously
monitored using a Masimo Radical-7® Pulse CO-Oximeter®, and a PVi
threshold of > 14% was used to determine whether fluid was
administered. (For patients with a PVi > 14%, a 250 mL
crystalloid solution was administered every 5 minutes; for patients
with a PVi < 14%, a 4 mL fluid infusion was administered.) In
the control group, fluid administration was determined using CVP,
other traditional parameters, and the 4-2-1 rule. In both groups,
lactate, hemoglobin, and hematocrit levels were also recorded.
The researchers found that the mean volume of intraoperative
fluid replacement was 1914 ± 542.86 mL in the PVi group and 3522 ±
1098.1 mL in the control group (p < 0.05). They found that the
mean units of intraoperative red blood cells (RBC) transfused was
0.08 ± 0.27 units in the PVi group and 0.42 ± 0.57 units in the
control group (p < 0.05). Differences between the groups in
postoperative RBC units transfused and intraoperative hemoglobin
levels were not significant.
The researchers concluded, “The present study has indicated that
PVi monitoring is more valuable than CVP monitoring because it is
noninvasive, provides better cardiac stabilization with less fluid
replacement, and [provides] more accurate results in the evaluation
of intravascular volume status. Failure to follow up the duration
of surgery and postoperative complications are the most important
limitations in our study.”
PVi has not been cleared by the FDA to assess fluid
responsiveness.
@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 200 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 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
- Çevikkalp E, Topçu I, Açikel A, Sarilar S, Keleş G, Özyurt B.
Efficacy of Pleth Variability Index (PVi) to Evaluate
Intraoperative Fluid Management During Orthopedic Spinal Surgery: A
Randomized Controlled Trial. JARSS. 2020;28(1):18-25.
- 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 PVi® and
Radical-7®. 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 PVi and Radical-7, 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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Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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