NEUCHATEL, Switzerland - Monday, 21. August 2023 AETOSWire
Researchers Found That Fluid Therapy Guided by Noninvasive, Continuous PVi Reduced Cardiopulmonary Complications and Fluid Administered
(BUSINESS WIRE) -- Masimo (NASDAQ: MASI) today announced
the findings of a prospective, randomized study published in Perioperative
Medicine in which Dr. Yu Wang and colleagues at institutions in Shenzhen,
Shaoguan, and Guangzhou, China evaluated the use of noninvasive, continuous
Masimo PVi®, as part of goal-directed fluid therapy (GDFT), to guide
intraoperative fluid administration during gastrointestinal (GI) surgery on
elderly patients by comparing it to conventional fluid therapy. The researchers
found that patients in the PVi group had a significantly lower rate of
cardiopulmonary complications (8.4% vs 19.2%) and had a significantly lower
total volume of fluid administered (median 2075 ml vs. 2500 ml).1
Noting the particular value of optimizing fluid management
during GI procedures, especially in elderly patients, because of the high rate
of postoperative complications and frequent fluid deficits (because of
preoperative fasting, bowel preparation, and intraoperative fluid loss), the
researchers sought to determine whether GDFT using Masimo PVi might improve
outcomes in this challenging scenario. PVi, or pleth variability index, is a
measure of the variations in perfusion index over the respiratory cycle, and
has the advantage, compared to arterial line-based methods of gauging fluid
responsiveness (e.g. stroke volume variation [SVV] and pulse pressure variation
[PPV]), of being obtained via noninvasive Masimo rainbow SET® pulse oximetry
and Pulse CO-Oximetry. PVi is indicated as a noninvasive, dynamic indicator of
fluid responsiveness in select populations of mechanically ventilated adult
patients. As the researchers note, PVi has been shown to perform similarly to
invasive methods of fluid assessment, such as PPV and SVV, in a variety of
surgeries.2
The researchers enrolled patients aged ≥ 65 years scheduled
for elective GI surgery at two university hospitals between November 2017 and
December 2020. Patients were randomly assigned to the GDFT group (n = 107) or
the conventional fluid therapy (CFT) group (n = 104). In the GDFT group, fluid
therapy was guided by PVi obtained from the photoplethysmographic waveform
measured by fingertip rainbow® Pulse CO-Oximetry sensors. The outcomes
evaluated and compared between the two groups were: composite complications at
30 days after surgery; cardiopulmonary complications at 30 days (pneumonia,
atelectatis, pulmonary edema, arrhythmia, and acute myocardial infarction);
time to first flatus; postoperative nausea and vomiting; infections including
anastomotic leak rates; and postoperative length of hospital stay.
The researchers found that the rate of cardiopulmonary complications, as well as the total volume of fluid administered intraoperatively, were statistically significantly lower in the GDFT (PVi) group, as highlighted in the table below. Although there was a trend toward shorter length of stay and lower anastomotic leakage rates in the PVi group, these and other outcomes were not statistically significantly different.
Joe Kiani, Founder and CEO of Masimo, said, “We introduced
PVi in 2007. It was the first and is still the only way of measuring fluid
responsiveness noninvasively via pulse oximetry, with our pulse oximeters, at a
fraction of the cost of invasive methods and without risk of invasive
procedures to the patient. Since then, PVi has made a tremendous contribution
to patient care, and its utility as a fluid responsiveness indicator has been
shown in more than 100 independent, published studies.2 This latest study adds
to the outcomes evidence that PVi can be used to help clinicians manage the
fluid levels of their patients without invasive catheters.”
In the U.S., PVi is FDA 510(k) cleared as a noninvasive
dynamic indicator of fluid responsiveness in select populations of mechanically
ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness
is variable and influenced by numerous patient, procedure and device related
factors. PVi measures the variation in the plethysmography amplitude but does
not provide measurements of stroke volume or cardiac output. Fluid management
decisions should be based on a complete assessment of the patient’s condition
and should not be based solely on PVi.
@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. In addition, Masimo Consumer Audio is
home to eight legendary audio brands, including Bowers & Wilkins, Denon,
Marantz, and Polk Audio. Our mission is to improve life, 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.3 Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,4 improve CCHD screening in newborns5
and, when used for continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU transfers, and
costs.6-9 Masimo SET® is estimated to be used on more than 200 million patients
in leading hospitals and other healthcare settings around the world,10 and is
the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the
2022-23 U.S. News and World Report Best Hospitals Honor Roll.11 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®, Radius PPG®, and
Radius VSM™, 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 and home automation and connectivity solutions
are centered around the Masimo Hospital Automation™ platform, and include Iris®
Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView
:60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness
solutions includes Radius Tº®, Masimo W1™, and Masimo Stork™. 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
Wang Y, Zhang Y, Zheng J, Dong X, Wu C, Guo Z, Wu, X.
Intraoperative pleth variability index-based fluid management therapy and
gastrointestinal surgical outcomes in elderly patients: a randomized controlled
trial. Periop. Med. 2023. 12:16. DOI: 10.1186/s13741-023-00308-0.
Published clinical studies on PVi can be found on our
website at http://www.masimo.com.
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 PVi®. 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, contribute to positive clinical outcomes and patient safety; risks that
the researchers’ conclusions and findings may be inaccurate; 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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Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
