New Study Investigates the Utility of Masimo ORi™, Oxygen Reserve Index, As an Indicator to Avoid Hyperoxia During General ...
15 July 2019 - 4:00PM
Business Wire
Masimo (NASDAQ: MASI) announced today that in a study recently
published in the Journal of Clinical Monitoring and Computing,
researchers investigated the ability of Masimo ORi™ (Oxygen Reserve
Index) to serve as a noninvasive indicator of the arterial partial
pressure of oxygen (PaO2) during general anesthesia, to help avoid
hyperoxia.1 ORi is an index of oxygenation in the moderate
hyperoxic region (PaO2 range of 100 to 200 mmHg). As an “index”
with a scale between 0.0 and 1.0, ORi can be trended to notify
clinicians of changes in a patient’s oxygen reserve.
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Masimo Root® with Radical-7® and ORi™
(Photo: Business Wire)
Dr. Keisuke Yoshida and colleagues at the Fukushima Medical
University School of Medicine in Japan sought to evaluate whether
ORi could provide continuous, noninvasive insight into avoiding
excessive hyperoxia by comparing the relationship between PaO2 and
ORi during various oxygen administration conditions. They enrolled
20 patients scheduled for surgery requiring general anesthesia. ORi
was measured using Masimo Root® with the Radical-7® Pulse
CO-Oximeter® and rainbow® sensors. PaO2 was measured using the
Siemens RAPIDLab® 1265 blood gas analyzer. For each patient, after
inducing anesthesia, blood gas analysis to measure PaO2 was
performed four times, with ORi values recorded each time blood was
drawn, providing 80 data sets. Initial analysis was performed with
inspired oxygen concentration (FiO2) set to 0.33, with the three
subsequent analyses performed when ORi was around 0.5, 0.2, and 0,
achieved by adjusting FiO2.
For analysis, the researchers chose an upper PaO2 threshold of
240 mmHg, based on a previous study that found a positive
correlation between ORi and PaO2 when PaO2 < 240 mmHg.2 They
defined hyperoxemia as PaO2 ≥ 150 mmHg. Using linear regression
analysis, the researchers found a “relatively strong” positive
correlation (r2 = 0.706) between ORi and PaO2 when PaO2 was less
than 240 mmHg. Using receiver operating characteristic (ROC) curve
analysis, they calculated that the optimal cut-off ORi value to
detect PaO2 ≥ 150 mmHg was 0.21 (sensitivity 0.950, specificity
0.755). Using four-quadrant plot analysis, they found that ORi
trended PaO2 with a 100% concordance rate.
The researchers concluded that “Hyperoxemia can be detected by
observing ORi of patients under general anesthesia, and thus
unnecessary administration of high concentration oxygen can
possibly be avoided.” They also noted, “ORi has unique
characteristics reflecting the state of oxygenation in the
hyperoxic range. The present study examined data under general
anesthesia in the operating room, but ORi’s unique features can
provide benefits not only in the operating room, but also in the
ICU and other fields. In the future, in order to make the most use
of ORi, further clinical study is required.”
As study limitations, the researchers noted the small number of
subjects in the study. In addition, they noted, “It is plausible
that a given patient’s factors (e.g. age, physique, body
temperature, finger perfusion, hemoglobin concentration) affect
their ORi value. Therefore, ORi might not reflect all changes in
PaO2.”
ORi has not received FDA 510(k) clearance and is not available
for sale in the United States.
@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.3 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,4 improve CCHD screening in newborns,5 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.6-8 Masimo SET® is estimated to be used on
more than 100 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 listed in the 2018-19 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 Iris®
platform, and include Iris Gateway™, Patient SafetyNet, Replica™,
Halo ION™, UniView™, and Doctella™. 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
- Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S,
Murakawa M. Adjustment of oxygen reserve index (ORi™) to avoid
excessive hyperoxia during general anesthesia. JCMC. 2019.
https://doi.org/10.1007/s10877-019-00341-9.
- Applegate R, Dorotta I, Wells B, Juma D, Applegate P. The
relationship between oxygen reserve index and arterial partial
pressure of oxygen during surgery. Anesth Analg. 2016;123:626–33.
https ://doi.org/10.1213/ANE.00000 00000 00126 2.
- 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 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; 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: Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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