SOUTHAMPTON, England-Tuesday 14 August 2018 [ AETOS Wire ]
(BUSINESS
WIRE) -- Masimo (NASDAQ: MASI) announced today the findings of a
recently published study in which researchers investigated whether home
pulse oximetry monitoring might be a useful initial screening method of
determining which children with Down syndrome (DS) – who are at high
risk of obstructive sleep apnea (OSA) – be recommended to undergo
multichannel sleep studies to diagnose the condition. The home
monitoring was conducted using Masimo SET® Measure-through Motion and
Low Perfusion™ pulse oximetry.1
Noting
that OSA “can only be reliably diagnosed using multichannel sleep
studies, which are expensive, demanding for families and only available
in specialist centres,” Dr. Hill and colleagues at the University of
Southampton and Southampton Children’s Hospital sought to determine
whether home pulse oximetry monitoring could identify children at high
risk of OSA, and in particular which parameters could most sensitively
detect this risk, as an initial screening step. To that end, they
studied 161 children with DS, aged 0.5 to 6 years, of whom 25 were
separately diagnosed with OSA. The patients were monitored overnight
using Masimo Radical-7® Pulse CO-Oximeters®, with pulse oximetry sensors
placed on the great toe. Recorded measurements included: total
artifact-free time analyzed, mean oxygen saturation (SpO2), minimum
SpO2, 3% oxyhemoglobin desaturation index (ODI), delta 12s index (the
absolute difference between successive 12 second interval recordings, a
measure of baseline SpO2 variability) and the number of minutes per hour
that SpO2 was below 90%.
Receiver
operating curves (ROC) and area under the curve (AUC) statistics were
calculated to determine which measurements, alone and in combination,
best predicted OSA status. During data analysis, researchers were
blinded to which children had separately received a diagnosis of OSA.
The researchers found that “the greatest AUC was achieved by the delta
12s index. At a threshold of >0.555, this identified 23/25
(sensitivity 92%) OSA cases and 89/136 true negatives (specificity 65%).
The same sensitivity was achieved for 3% ODI with marginally lower
specificity of 63% (86/136 true negatives).” The combined model (delta
12s index, 3% ODI, mean and minimum SpO2) detected all true positives
(100% sensitivity) but with lower specificity (53%). This result would
lead 60% of the sample population (12 true positives and 18 false
negatives) to confirmatory multichannel studies.
The
researchers concluded that “universal screening for OSA in children
with DS using simple pulse oximetry parameters could halve the number of
children requiring specialist multichannel studies. Pulse oximetry is
widely available, well tolerated, readily acquired in the home and its
adoption could reduce the burden on health services and families alike.”
The
researchers noted that “our findings specifically apply to parameters
generated by Masimo oximeters and cannot be generalised to other
devices. Masimo technology extracts motion artefact, this is important
in children with DS who are restless sleepers.” They also noted that
“the use of a retrospective clinical dataset, with anonymous data shared
for this analysis, limits our information on the wider sampling frame,
demographic and clinical characteristics of these children.”
Masimo
pulse oximetry is not cleared in the United States to screen children
with Down syndrome for risk of obstructive sleep apnea.
@MasimoInnovates | #Masimo
Reference
Hill
C, Elphick H, Farquhar M, Gringras P, Pickering R, Kingshott R, Martin
J, Reynolds J, Joyce A, Gavlak J, and Evans H. Home oximetry to screen
for obstructive sleep apnoea in Down syndrome. Arch Dis Child.
doi:10.1136/archdischild-2017-314409.
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/evidence/featured-studies/feature/.
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 SET® and Radical-7®. 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 SET® and Radical-7, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180813005147/en/
Contacts
Media Contact:
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com
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