Masimo (NASDAQ: MASI) today announced the results of a study
published in Pneumonia in which independent researchers in New
Delhi, India, investigated the accuracy of Masimo RRp® on pediatric
patients with the Rad-G™ Pulse Oximeter by comparing it to
clinician-determined values while performing routine assessment of
children admitted to outpatient and emergency departments.1 RRp
provides respiration rate determined from the photoplethysmograph
used in pulse oximetry.
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Masimo Rad-G™ with RRp® (Photo: Business
Wire)
Noting the high incidence of childhood pneumonia in many parts
of the world, the inclusion of oxygen saturation (SpO2) and
respiratory rate measurement in pneumonia screening guidelines, and
the scarcity of medical equipment and variability in medical
training in many low-resource settings, Dr. Alwadhi and colleagues
sought to determine whether a “multi-modal” pulse oximeter, Masimo
Rad-G, could also accurately measure respiration rate—supporting
future applications for a more streamlined and reliable approach to
pneumonia screening case management. Rad-G uses a single Masimo
SET® pulse oximetry sensor to measure both SpO2 and RRp, as well as
pulse rate (PR), perfusion index (Pi), and pleth variability index
(PVi®).
In this particular study, the researchers used Rad-G, alongside
traditional pediatrician assessment, to measure the respiration
rate of 97 children (aged 2 to 59 months) admitted to the
outpatient and emergency departments at Kalawati Saran Hospital in
New Delhi, over 2 weeks. They then analyzed the level of agreement
between plethysmography-based respiration rate (RRp) and the
clinicians’ assessment of respiration rate.
The researchers found that RRp and the control respiration rate
measurement method showed “significant strong association (97%)” (p
< 0.001), and that “values obtained either from pulse oximeter
or by pediatrician (gold standard) are very close to each other.”
For assessing fast breathing (defined as ≥ 50 breaths per minute
(bpm) for infants 2 to 12 months and ≥ 40 bpm for children older
than 12 months), RRp had high sensitivity (95%) and specificity
(94%), with 95% accuracy. Based on these findings, the authors
explained, “The sensitivity analysis, in addition, points to the
reliability of the device in correctly identifying fast breathing,
a major symptom of the disease [pneumonia], in 95% of the cases.”
They also noted that Rad-G “allows for significantly integrated
results of RR and SpO2 with high sensitivity and accuracy in health
care settings, as well as the possibility of rapid detection.”
The researchers concluded, “There is a high degree of agreement
between pleth-based RR using a [pulse oximetry device] and
physician measured RR, indicating that the former provides reliable
and accurate measurement. Current diagnosis and management of
pneumonia in primary health care is based on variably trained
health providers despite IMCI [Integrated Management for Childhood
Illness] guidelines. The use of pulse oximeters, also recommended
by the WHO, which can provide reliable measurement, would
streamline pneumonia case management in these settings. The current
study provides evidence of the reliability of pulse
oximeter[s].”
Masimo RRp is CE marked and U.S. FDA 510(k) cleared. Rad-G is
currently CE marked and the U.S. FDA 510(k) clearance is
pending.
@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 200 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 according to 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 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.
* The use of the trademark Bridge is under license from
Innovative Health Solutions
References
- Alwadhi V, Sarin E, Kumar P, Saboth P, Khera A, Gupta S, Kumar
H. Measuring accuracy of plethysmography based respiratory rate
measurement using pulse oximeter at a tertiary hospital in India.
Pneumonia. 2020. 12:4.
https://doi.org/10.1186/s41479-020-00067-2.
- 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 RRp® and Rad-G™.
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 RRp and Rad-G, 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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