Researchers Found That ORi-Guided Thoracic
Anesthesia May Reduce Hospital Length of Stay and Increase Patient
Safety
Masimo (NASDAQ: MASI) announced today the findings of a study
published in the Turkish Journal of Medical Sciences in which Dr.
Ayten Saracoglu and colleagues at the Marmara University Pendik
Training and Research Hospital in Istanbul evaluated the ability of
ORi to guide oxygenation by measuring its impact on
hyperoxemia-mediated morbidity during one-lung ventilation (OLV)
conducted as part of thoracic surgery.1 They concluded that
ORi-guided oxygen titration “may reduce hospital stay and increase
patient safety.”
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Masimo Root® with ORi™ (Photo: Business
Wire)
ORi, available outside the U.S. since 2014, is a noninvasive and
continuous parameter intended to provide additional insight into a
patient’s oxygen status under supplemental oxygen. Enabled by the
multi-wavelength rainbow® Pulse CO-Oximetry platform, ORi is
provided alongside oxygen saturation (SpO2) measured by clinically
proven Masimo SET® pulse oximetry.
Noting that during OLV, a common technique for facilitating a
wide variety of pulmonary procedures, 100% fraction of inspired
oxygen (FiO2) supplemental oxygen administration is commonly used,
which exposes patients to the possibility of hyperoxia-induced lung
injury, the researchers sought to determine whether ORi could
“protect patient from the harmful effects of hyperoxemia with a
noninvasive probe during OLV.” They divided 103 patients with lung
tumors (18-70 years of age, ASA I-III), enrolled between September
2018 and September 2019 and requiring OLV as part of elective
thoracic surgery, into four groups as noted below:
Group
Number of
Subjects
Duration of OLV with FiO2
> 60%
Mean FiO2 values
1: Oxygen titration without ORi, low-flow
anesthesia (1 L/min)
25
67.6 ± 97.5 mins.
71.6 ± 12.25%
2: Oxygen titration without ORi, high-flow
anesthesia (4 L/min)
28
97.32 ± 99.7 mins.
74.64 ± 16.66%
3: Oxygen titration with ORi, low-flow
anesthesia (1 L/min)
25
39.2 ± 74.1 mins.
62.8 ± 13.08%
4: Oxygen titration with ORi, high-flow
anesthesia (4 L/min)
25
22.4 ± 49.4 mins.
56.4 ± 11.5%
During OLV, oxygen titration was performed without ORi for
patients in groups 1 and 2, while groups 3 and 4 used ORi from
Masimo Radical-7® Pulse CO-Oximeters® and rainbow® sensors. For all
4 groups, SpO2 and partial pressure of arterial oxygen (PaO2) were
routinely measured while FiO2 was routinely administered at 50%
after induction, rising to 60% when the OLV was applied, and
increasing to 70%-100% as necessary.
The researchers found that ORi monitoring was associated with
significantly shorter duration of OLV with FiO2 > 60%, with
significantly lower mean FiO2 values during OLV (as shown in the
table above), and with lower recorded PaO2 values. They also found
that the duration of FiO2 > 80% during OLV was strongly
correlated with longer hospital stays (p < 0.001).
The observation that mean FiO2 values were found to be
significantly lower in the ORi groups (3 and 4), compared to the
groups without ORi (1 and 2), led the researchers to hypothesize
that “the risk of hyperoxia will be lower in patients undergoing
ORi monitor[ing].” The researchers noted, “ORi cannot replace
arterial blood gas analysis; however, it is useful to assess
oxygenation. In groups without ORi monitors, the FiO2 was
significantly higher than 80%. Moreover, in our study, it was
revealed that these patients had a longer hospital stay.”
There was no significant difference in ORi values between the
low-flow (group 3) and high-flow (group 4) cohorts.
The researchers concluded, “The adjustment of ORi with
peripheral oxygen saturation and blood gas analysis demonstrated
that hyperoxemia could be prevented during OLV in patients under
low flow or high flow anesthesia. We concluded that ORi-guided
thoracic anesthesia may reduce hospital stay and increase patient
safety.”
ORi has not yet received FDA clearance and is not available 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, reduce the
cost of care, and take noninvasive monitoring to new sites and
applications. 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.5-8 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,
iSirona™, 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
- Saracoglu A, Yamansavci Şirzai E, Yildizeli B, Yüksel M, Aykaç
ZZ. Oxygen Reserve Index Guided Oxygen Titration in One Lung
Ventilation with Low Fresh Gas Glow. Turkish Journal of Medical
Sciences. 2021 May. DOI: 10.3906/sag-2009-149.
- 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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