NEUCHATEL, Switzerland-Monday 6 July 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- 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.
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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Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
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