NEUCHATEL, Switzerland-Tuesday 5 May 2020 [ AETOS Wire ]
(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
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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Contacts
Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
