Study Investigates the Utility of Masimo ORi™, Oxygen Reserve Index, to Reduce Hyperoxia in Critically Ill Patients
August 26 2019 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today that in a randomized
controlled study involving 150 ICU patients recently published as a
letter in Intensive Care Medicine, researchers investigated whether
monitoring with Masimo ORi™ (Oxygen Reserve Index) could reduce the
time critically ill patients spend with moderate hyperoxia,
compared to monitoring with oxygen saturation (SpO2) alone.1 ORi is
an index of oxygenation in the moderate hyperoxic region, defined
as arterial partial pressure of oxygen, PaO2, in the 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® and Radical-7® with ORi™
(Photo: Business Wire)
Dr. Sigismond Lasocki and colleagues at the Centre Hospitalier
Universitaire of Angers, France (CHU Angers), sought to evaluate
whether controlling the fraction of inspired oxygen (FiO2) in
mechanically ventilated patients based on monitoring with ORi,
rather than with SpO2 alone, could reduce the time patients spend
in a moderately hyperoxic state (PaO2 ≥ 100 mmHg). 150 critically
ill adult patients, all of whom were mechanically ventilated for at
least 2 days, were divided randomly into an ORi and a control
group. ORi and SpO2 were measured using the Masimo Root® Patient
Monitoring and Connectivity Platform and rainbow® sensors. In the
ORi group, nurses were instructed to decrease FiO2 when ORi ≥ 0.01.
In the control (SpO2 only) group, they were instructed to decrease
FiO2 when SpO2 ≥ a prescribed upper limit. PaO2 was measured by
analyzing arterial blood gasses.
Data from 75 patients in the ORi group and 71 patients in the
control group were analyzed. The researchers found that monitoring
with ORi allowed a statistically significant reduction in the
percentage of days patients spent with hyperoxia without a
statistically significant increase in hypoxia: 14% were hyperoxic
(0 to 33%) in the ORi group vs. 33% (11 to 56%) in the control
group (p = 0.003). The percentage of hours spent with hyperoxia was
also “much lower” using ORi: 7.4% were hyperoxic (0 – 24.8%) in the
ORi group vs. 17.3% (3.8 – 43.1%) in the control group for PaO2 ≥
100 mmHg (p = 0.0069), and 0% (0 – 7.2%) in the ORi group vs. 5.6%
(0 – 18.1%) in the control group for PaO2 ≥ 120 mmHg (p =
0.0037).
The researchers concluded that “The use of ORi monitoring to
titrate oxygen rates allowed an important reduction of the time
spent with hyperoxia compared with the use of SpO2 alone, probably
because nurses are reluctant to decrease oxygen rates when SpO2 is
in a normal range. A nurse-driven protocol to adjust FiO2 according
to SpO2 was already in place in our unit, explaining why the
percentage of time with hyperoxia we observed in the control group
was much less than usually reported (30 vs 60%). This strategy to
decrease oxygen rate according to ORi (which detects high PaO2) may
thus be even more efficient in units where there is no protocol to
adjust oxygen rates. SpO2 could remain a warning for hypoxia and
ORi for hyperoxia. Larger studies are needed to evaluate the
clinical benefit of this strategy.”
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.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.5-7 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,8 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S.
News and World Report Best Hospitals Honor Roll.9 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
- Lasocki S, Brochant A, Leger M, Gaillard T, Lemarié P, Gergaud
S, and Dupré P. ORi monitoring allows a reduction of time with
hyperoxia in critically ill patients: the randomized control ORi
study. Intensive Care Med. 13 Aug 2019.
https://doi.org/10.1007/s00134-019-05732-9.
- 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 Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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