NEUCHATEL, Switzerland-Monday 12 October 2020 [ AETOS Wire ]
(BUSINESS
WIRE)-- Masimo (NASDAQ: MASI) today announced the findings of an
abstract recently presented at ANESTHESIOLOGY® 2020, the Annual Meeting
of the American Society of Anesthesiologists (ASA). In this independent,
retrospective study, researchers investigated whether Masimo ORi™
(Oxygen Reserve Index) could predict whether children with obstructive
sleep apnea syndrome (OSAS) undergoing tonsillectomy required
postoperative oxygen therapy.
ORi, available outside the U.S., is
a noninvasive and continuous parameter intended to provide insight into
a patient’s oxygen status during moderate hyperoxia. Enabled by the
multi-wavelength rainbow® Pulse CO-Oximetry platform, ORi is provided
alongside oxygen saturation (SpO2), a clinically proven Masimo SET®
pulse oximetry measurement.
Dr. Yoshimi Inagaki and colleagues at
Tottori University in Yonago, Japan sought to determine whether Masimo
ORi could serve as a useful predictor of the need for postoperative
oxygen therapy (POT). They enrolled 45 pediatric patients with OSAS,
ranging from 7 to 120 months, who were anesthetized with sevoflurane and
monitored with ORi while undergoing tonsillectomy.
Of the 45
patients, 16 required POT. For those 16, the mean lowest ORi and SpO2
values were 0.28 and 93%, respectively. For the remaining patients, who
did not receive POT, the mean lowest values were 0.64 and 97%,
respectively. The researchers calculated sensitivity and specificity for
ORi predicting when POT would not be needed of 0.815 (95% confidence
interval 0.5435 – 0.9595) and 0.9310 (95% confidence interval 0.7723 –
0.9915), respectively.
The researchers concluded that ORi is
“likely to become an index of POT in pediatric patients with OSAS.” They
also noted, “In children with OSAS, [the] requirement of POT following
tonsillectomy and adenoidectomy is probably able to be predicted on the
basis of the results of this retrospective cohort study.”
ORi has not received FDA 510(k) clearance and is not available for sale 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 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.5-8 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®, 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
Inagaki Y, Kitagawa Y, Otsuki A. Oxygen Reserve Index Predicts
Postoperative Oxygen Requirement after Tonsillectomy in Children with
Obstructive Sleep Apnea Syndrome. Proceedings from the ASA 2020 Annual
Meeting. Abstract #A4091. Accessed 10/8/20 at
https://epostersonline.com/asa2020/node/739?view=true.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201011005050/en/
Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
Permalink
:
https://www.aetoswire.com/news/researchers-use-masimo-oritrade-oxygen-reserve-index-to-predict-the-need-for-postoperative-oxygen-therapy-in-pediatric-patients-with-obstructive-sleep-apnea/en
No comments:
Post a Comment