New Study Investigates the Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorecta...
July 16 2018 - 1:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today the findings of a
recently published study in which researchers at Kocaeli University
in Turkey compared the performance of conventional fluid management
(CFM) to goal-directed fluid management (GDFM) using Masimo PVi®
(pleth variability index, measured noninvasively and continuously
using SET® pulse oximetry sensors) in patients undergoing elective
colorectal surgery. The primary points of comparison were the
amount of crystalloids administered and blood lactate and serum
creatinine levels during the intraoperative period.1
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Masimo Radical-7® with PVi®, SpHb®, and
RD rainbow SET™ Sensor (Photo: Business Wire)
In the study, Dr. Cesur and colleagues, noting the importance of
intraoperative fluid management in terms of postoperative organ
perfusion and complications, sought to compare the effects of CFM
(guided by clinical assessment and heart rate, arterial blood
pressure, and invasively measured central venous pressure) with
GDFM (guided by clinical assessment and noninvasive Masimo PVi
monitoring). They enrolled 70 ASA I-II adult patients undergoing
elective colorectal tumor surgery, who were divided randomly into
CFM and GDFM groups. PVi was measured using a Masimo Radical-7®
Pulse CO-Oximeter® with software version 7.0.3.3 and SET® sensors.
In the CFM group, an NaCl solution was administered at the rate of
4-8 ml/kg/h; when mean arterial pressure (MAP) fell below 65 mmHg
or 30% baseline MAP, the speed of infusion was increased, colloid
was initiated, and ephedrine was administered. In the GDFM group,
the same solution was administered at the rate of 2 ml/kg/h; if PVi
rose above 13% for more than 5 minutes, colloid and then ephedrine
were administered. Treatments in both groups were continued until
values were restored to each protocol’s pre-treatment
threshold.
The researchers found that intraoperative crystalloid
administration, urine output, and end-surgery fluid balance were
significantly lower in the GDFM (PVi) group:
Characteristic Median value (25-75
percentile values): CFM group Median
value (25-75 percentile values): GDFM (PVi) group
P-value Intraoperative Crystalloid administration
1946 ml (1500-2500 ml) 900 ml
(800-1060 ml) <0.001 Urine output
400 ml (250-600 ml) 300 ml (200-400 ml)
0.018 End-surgery fluid balance
1400 ml (960-2250 ml) 620 ml (410-1000 ml)
<0.001
Durations of anesthesia and of surgery, as well as the amounts
of intraoperative bleeding and administered colloid, were similar.
The length of hospital stay was also found to be similar between
the two groups.
The researchers noted that a limitation of the study was that
they chose the number of subjects based on the needs of their
primary objective, the comparison of intraoperative fluid volume
between the two protocols, so they may not have evaluated enough
subjects to effectively compare secondary outcomes such as length
of stay: “We determined the primary goal of this study as the
amount of intraoperative fluid volume and established 35 patients
were needed for each group; if postoperative complications, the
length of hospital stay[, were] determined as the primary goal,
perhaps our numbers [in] each group [w]ould be different.”
@MasimoInnovates | #Masimo
Reference
- Cesur S, Cardakozu T, Alparslan K,
Turkyilmaz N, and Yavuz O. Comparison of conventional fluid
management with PVI-based goal-directed fluid management in
elective colorectal surgery. J Clin Mon. 14 June 2018.
https://doi.org/10.1007/s10877-018-0163-y
About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative
noninvasive monitoring technologies. Our mission is to improve
patient outcomes and reduce the cost of care. In 1995, the company
debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse
oximetry, which has been shown in multiple studies to significantly
reduce false alarms and accurately monitor for true alarms. Masimo
SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,1 improve CCHD screening in
newborns,2 and, when used for continuous monitoring with Masimo
Patient SafetyNet™* in post-surgical wards, reduce rapid response
activations and costs.3,4,5 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,6 and is the primary pulse
oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S.
News and World Report Best Hospitals Honor Roll.7 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®),
and more recently, Oxygen Reserve Index (ORi™), in addition to
SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo
introduced Root®, an intuitive patient monitoring and connectivity
platform with the Masimo Open Connect® (MOC-9®) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in
mHealth with products such as the Radius-7® wearable patient
monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and
its products may be found at www.masimo.com. Published clinical
studies on Masimo products can be found at
http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available
for sale in the United States.
*The use of the trademark Patient SafetyNet is under license
from University HealthSystem Consortium.
References
- 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 AH 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®. 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 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 Lamb, 949-396-3376elamb@masimo.com
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