New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™, in Obese Patients
January 22 2018 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today the findings of an
abstract presented at the annual meeting of the Society for
Technology in Anesthesia (STA) in Miami, Florida. In the study,
researchers at the UC Davis School of Medicine evaluated the
potential clinical utility of Masimo Oxygen Reserve Index™ (ORi™)
as an early warning of impending arterial hemoglobin desaturation
in obese patients.1 This is the first published research
investigating the utility of ORi in this particular population
group.
ORi is a relative indicator of a patient’s oxygen reserve in the
moderate hyperoxic region (partial pressure of oxygen in arterial
blood [PaO2] in the range of 100 to 200 mmHg). As an “index”
parameter with a unit-less scale between 0 and 1, ORi can be
trended and has optional alarms to notify clinicians of changes in
a patient’s oxygen reserve.
In the prospective, observational study, Dr. Ayala and
colleagues analyzed data from 36 adult patients with BMI between 30
and 40 kg/m2 who were scheduled for elective surgical procedures
requiring general anesthesia and endotracheal intubation. The
patients’ ORi values were measured using a Masimo Root® Patient
Monitoring and Connectivity Platform with Radical-7® Pulse
CO-Oximeter®. The researchers recorded the time elapsed from the
start of ORi alarming (triggered by decrease in the absolute value
and rate of change in ORi) to 98% oxygen saturation, and considered
this interval to be the average increase in warning time provided
by ORi.
The researchers found that among the patients, the average time
from the start of ORi alarming to 98% oxygen saturation was 42 ± 49
seconds (ranging from 5 to 255 seconds). Excluding two outliers,
the average increase in warning time provided by ORi was 33 ± 23
seconds (ranging from 5 to 107 seconds).
The researchers concluded that the study “demonstrates the
ability of ORi to provide advanced warning of arterial desaturation
as an adjunct to SpO2 in this high risk patient population. This
additional warning time can potentially translate to improved
patient safety by allowing earlier calls for help, assistance from
a more experienced person, or modification of airway management.
For this analysis we defined the advance warning to end at 98%
SpO2, with a defined trigger for intervention at 94% SpO2.”
In another study, researchers at Children’s Medical Center in
Dallas, Texas concluded that ORi could provide clinicians with a
median of 31.5 seconds advanced warning of impending desaturation
in pediatric patients with induced apnea after
pre-oxygenation.2
UC Davis received funding from Masimo for the ORi study.
ORi has not received FDA 510(k) clearance and is not available
for sale in the United States.
@MasimoInnovates | #Masimo
References
- Ayala S, Singh A, Applegate R, and
Fleming N. Oxygen Reserve Index: Utility as Early Warning of
Desaturation in Morbidly Obese Patients. Proceedings from the 2018
STA Annual Meeting, Miami, FL.
- Szmuk P et al. Oxygen Reserve Index A
Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study.
Anesthesiology. 4 2016, Vol. 124, 779-784.
doi:10.1097/ALN.0000000000001009.
About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative
noninvasive monitoring technologies. Our mission is to improve
patient outcomes and reduce the cost of care. In 1995, the company
debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse
oximetry, which has been shown in multiple studies to significantly
reduce false alarms and accurately monitor for true alarms. Masimo
SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,1 improve CCHD screening in
newborns,2 and, when used for continuous monitoring with Masimo
Patient SafetyNet™* in post-surgical wards, reduce rapid response
activations and costs.3,4,5 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,6 and is the primary pulse
oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S.
News and World Report Best Hospitals Honor Roll.7 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®),
and more recently, Oxygen Reserve Index™ (ORi™), in addition to
SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo
introduced Root®, an intuitive patient monitoring and connectivity
platform with the Masimo Open Connect™ (MOC-9™) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in
mHealth with products such as the Radius-7™ wearable patient
monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and
its products may be found at www.masimo.com. Published clinical
studies on Masimo products can be found at
http://www.masimo.com/cpub/clinical-evidence.htm.
ORi 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
- 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 AH 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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MasimoEvan Lamb, 949-396-3376elamb@masimo.com
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