In the Largest Study of ORi to Date, of 554
Patients, Researchers Conclude: “ORi Can Provide Useful Information
on Arterial Oxygenation Even During One-Lung Ventilation”
Masimo (NASDAQ: MASI) today announced the findings of a
retrospective study published in the Journal of Anesthesia in which
Dr. Yu Jeong Bang and colleagues at the Samsung Medical Center,
Sungkyunkwan University School of Medicine, in Seoul, South Korea,
investigated the association of Masimo ORi™ and the arterial
partial pressure of oxygen (PaO2) in 554 patients who underwent
non-cardiac thoracic surgery during one-lung ventilation (OLV),
making this study the largest to date on ORi. The researchers found
that ORi values “were significantly correlated with PaO2 measured
simultaneously” and that ORi “could provide useful information on
arterial oxygenation even during one-lung ventilation.”1
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Masimo Root® with ORi™ (Photo: Business
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Noninvasive, continuous Masimo ORi provides continuous,
real-time insight into the oxygenation of hemoglobin in the
moderate hyperoxic range (PaO2 > 100 and ≤ 250 mmHg) to be used
alongside arterial blood gas analyses, which have the drawbacks of
being invasive, intermittent, and delayed. ORi is trended
continuously with SpO2 as a unit-less index between 0.00 and 1.00
to extend the visibility of the patient oxygenation beyond SpO2
under supplemental oxygen. By convention, SpO2 is limited to an
upper limit of 100%, but oxygenation is not limited and can rise
into hyperoxia (higher than normal oxygenation state) when
supplemental oxygen is administered. ORi provides clinicians with
additional visibility, as a complement to SpO2 monitoring with
Masimo SET® pulse oximetry, into when oxygenation is increased
into, or decreased out of, moderate hyperoxia, in real time.
Noting the importance of striving to prevent hyperoxemia and
hypoxemia especially during surgery requiring OLV, because of the
risk of pulmonary complications, the researchers sought to evaluate
a noninvasive, continuous method of predicting imminent over- or
under-oxygenation to overcome the drawbacks of invasive blood gas
analysis alone, using Masimo ORi. To evaluate ORi’s performance,
they analyzed data collected from 554 patients who underwent
non-cardiac elective thoracic surgery requiring OLV between January
1 and December 31, 2022 at a tertiary hospital in South Korea.
During anesthesia, ORi was monitored using Masimo RD rainbow SET®
Pulse CO-Oximetry sensors, and blood gas analysis was performed 15
minutes after OLV was initiated. The researchers’ primary endpoint
was the association between simultaneous ORi and PaO2 values. They
also sought to identify risk factors for PaO2 < 150 mmHg, based
on their clinical experience that most patients with PaO2 > 150
mmHg in this scenario rarely show hypoxemia.
The researchers found a linear correlation between ORi and PaO2
measured simultaneously. Using linear regression analysis, they
found there was a statistically significant positive relationship
between ORi and PaO2 measured 15 minutes after OLV initiation (r2 =
0.5752, p < 0.001). Using receiver-operated curve (ROC)
analysis, they identified an optimal cut-off ORi value of 0.27 to
detect PaO2 ≥ 150 mmHg during OLV (area under the ROC curve of
0.96, 95% confidence interval of 0.94 – 0.98, sensitivity 0.909,
specificity 0.932). Of the 11 potential predictors for PaO2 <
150 mmHg identified by the researchers, ORi was highly predictive
(odds ratio 0.001, p < 0.001).
The researchers concluded, “ORi values during one-lung
ventilation were significantly correlated with PaO2 measured
simultaneously. Therefore, the ORi monitor can provide useful
information for estimating the PaO2 value even during one-lung
ventilation.”
In the U.S., ORi has been granted a De Novo by the FDA to be
used in patients undergoing surgery as an adjunct to SpO2 for
increased monitoring resolution of elevated hemoglobin oxygen
saturation levels (e.g., due to administration of supplemental
oxygen). The ORi feature is indicated for the monitoring of
hemoglobin oxygen saturation levels in patients 18 years and older
(adults and transitional adolescents) on supplemental oxygen during
no-motion conditions perioperatively in hospital environments.
@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.2
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,3 improve CCHD screening in
newborns4 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
team activations, ICU transfers, and costs.5-8 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 as ranked
in the 2022-23 U.S. News and World Report Best Hospitals Honor
Roll.10 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® and
Masimo W1®. 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/.
RPVi 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
- Bang Y, Seong Y, Jeong H. Association between Oxygen Reserve
index nd arterial partial pressure of oxygen during one-lung
ventilation: a retrospective cohort study. J Anesth. 7 Sept 2023.
DOI: 10.1007/s00540-023-03259-4
- 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 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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