Researchers Use Masimo ORi™, Oxygen Reserve Index, to Help Suppress Postoperative Hyperoxia in Patients Undergoing Breast S...
December 14 2020 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today the findings of an
abstract recently presented at Euroanaesthesia 2020 in which Dr.
Kumagai and colleagues at Iwate Medical University Hospital in
Yahaba-cho, Japan investigated whether Masimo ORi™, Oxygen Reserve
Index, could be used to limit the extent of postoperative
hyperoxia.1 The researchers concluded that ORi helped “suppress
hyperoxia, preventing hypoxia.”
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Masimo Root® with ORi™ (Photo: Business
Wire)
ORi, available outside the U.S., is a noninvasive and continuous
parameter intended to provide insight into a patient’s oxygen
status during moderate hyperoxia. Enabled by the multi-wavelength
rainbow® Pulse CO-Oximetry platform, ORi is provided alongside
oxygen saturation (SpO2), a clinically proven Masimo SET® pulse
oximetry measurement.
Noting that postoperative hyperoxia is associated with various
adverse outcomes—including “acute lung injury, increased hospital
mortality, and worse outcomes in patients with ischemic stroke”—the
researchers sought to determine whether a noninvasive, continuous
parameter could help clinicians assess the appropriate amount of
supplemental oxygen to administer to surgical patients, so as to
limit hyperoxia post-surgery. They divided 50 patients scheduled
for breast surgery into a group receiving ORi-based oxygen
treatment (group O) and a control group that received conventional
postoperative oxygen treatment (group C). In group C, after
extubation, oxygen was administered at a fixed rate (4 L/min); in
group O, oxygen was administered at 4 L/min but decreased by 0.5
L/min if ORi > 0.00, until ORi was 0.00 for 30 minutes
continuously. Blood gas analysis was performed at various
intervals. Hyperoxia was defined as partial pressure of arterial
oxygen (PaO2) > 120 mmHg, and hypoxia as oxygen saturation
(SpO2) ≤ 94% for more than 1 minute.
The researchers found that PaO2 was significantly lower in the
ORi group both before patients left the PACU (mean 117.3 mmHg [one
standard deviation 26.8 mmHg] in group O vs. 170.0 mmHg [42.8 mmHg]
in group C) and the morning after surgery (107.5 mmHg [16.5 mmHg]
in group O vs. 157.1 mmHg [28.4 mmHg] in group C); p < 0.01. No
patients had hypoxia.
The researchers concluded, “Determining postoperative
supplemental oxygen amount using ORi can noninvasively suppress
hyperoxia, preventing hypoxia.”
ORi has not received FDA 510(k) clearance and is not available
for sale in the United States.
@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. 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 costs5-8 Masimo SET® is estimated to be used on more
than 200 million patients in leading hospitals and other healthcare
settings around the world,9 and is the primary pulse oximetry at 9
of the top 10 hospitals according to the 2020-21 U.S. News and
World Report Best Hospitals Honor Roll.10 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
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, 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
- Kumagai M, Koishi W, Kurihara H, Eizuka A, Suzuki K.
Contribution of the novel pulse oximeter-based index in determining
the amount of postoperative supplemental oxygen needed. Proceedings
from the Euroanaesthesia 2020 Annual Meeting. #4339.
- 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 ORi™. 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 ORi, 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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