TOKYO--(BUSINESS WIRE)--Jul. 31, 2017--
MASI) announced today that researchers at the Tokyo Women’s Medical
University, Department of Anesthesiology, in Japan have published a
study investigating the measurement of respiration rate in volunteers.
Masimo acoustic respiration rate (Masimo), using the Masimo Radical-7®
Pulse CO-Oximeter®, was studied alongside Nellcor
plethysmographic respiration rate (Nellcor), using the Nellcor PM1000N.1
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Masimo Radical-7® Pulse CO-Oximeter® with RAS-125c Respiratory Acoustic Sensor (Photo: Business Wire)
Dr. Kitsiripant and colleagues enrolled 50 healthy adult volunteers in
the study. Respiration rate, pulse rate, and oxygen saturation (SpO2)
values were measured using the two technologies: Nellcor respiration
rate, pulse rate, and SpO2 on PM1000N (version 18.104.22.168) were
measured using an SpO2 adhesive sensor on the left index
finger; Masimo respiration rate on Radical-7 (V.7910, processor
V1.3.06i) was measured using the RAS-125c (rev D) acoustic sensor on the
left side of the neck, with an R1-25L adhesive sensor on the right index
finger measuring Masimo pulse rate and SpO2.
Both devices were configured to alarm in the event of respiratory pause
(Masimo) or low respiration rate (Nellcor) for 30 seconds, respiration
rate under 10 breaths/minute, and SpO2 of 90% or below. The
volunteers were required to breathe at a rate of 12 breaths/minute for 3
minutes, then hold their breath until one of the device’s respiratory
pause/low respiration rate alarms was triggered, then resume breathing.
Because of the difficulty for some volunteers of completely stopping
airflow for 30 seconds, a smaller group of 10 volunteers was recruited
to perform the same procedure but with respiratory pause/low respiration
rate alarms set to 15 seconds.
Of the 143 procedures in which breathing was successfully held for more
than 30 seconds, Masimo alarmed 114 times and Nellcor alarmed 15 times.
The average time to alarm for Masimo was 35 seconds and for Nellcor, 59
seconds. Most of the alarms for Nellcor followed from SpO2
being < 90%, whereas most for Masimo were caused by respiration rate <
10 breaths/minute (which tended to occur prior to the drop in SpO2).
Of the 29 procedures in which breathing was held for 15 seconds, Masimo
alarmed 29 times, with an average time to alarm of 21 seconds, and
Nellcor did not alarm at all.
The researchers concluded that Masimo acoustic respiration rate provided
faster detection of respiratory pause than Nellcor, but it should be
noted as a limitation of the study that the measurements were taken
using volunteer participants who maintained a fixed breathing rate and
then abruptly held their breath.
rainbow Acoustic Monitoring® sensors and cables are indicated
for the continuous, noninvasive monitoring of respiratory rate (RRa®).
The RAS-125c sensor is indicated for adult and pediatric patients, in
hospitals, hospital-type facilities, mobile and home environments.
Kitsiripant C et al. Comparison of Nellcor™ PM1000N and Masimo
Radical-7® for detecting apnea in volunteers. J Anesth.
9 July 2017. DOI: 10.1007/s00540-017-2385-4.
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 16 of the top 20
hospitals listed in the 2016-17 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.
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;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.
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 RRa®. 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 RRa, 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: http://www.businesswire.com/news/home/20170731005381/en/
Evan Lamb, 949-396-3376