For Breath Rates Less Than or Equal to 4 Breaths Per Minute, RAM
Showed 78% True Positives and 22% False Positives, While Capnography
Showed 30% True Positives and 70% False Positives
IRVINE, Calif.--(BUSINESS WIRE)--Feb. 12, 2016--
Masimo
(NASDAQ: MASI) announced today that Masimo’s rainbow® Acoustic
Monitoring (RAM™) was associated with fewer alarm events during planned
moderate sedation in a new clinical study.1
This two-part pilot study used RAM and SedLine® brain function
monitoring as the additional monitoring parameters during planned
moderate sedation to (1) determine the incidences of alarm events
(desaturation, respiratory depression and deeper than intended
sedation), and (2) determine whether monitoring with these parameters is
associated with fewer alarm events.
RAM noninvasively and continuously measures respiration rate using an
innovative adhesive sensor with an integrated acoustic transducer that
is applied to the patient’s neck.
In the two-part study, published in the journal Anesthesia & Analgesia
by Dr. Richard Applegate II and colleagues from the Loma Linda
University School of Medicine, data were collected from adult patients
undergoing gastroenterology or interventional radiology procedures under
moderate sedation. The patients were monitored per standard protocols
(electrocardiography, blood pressure, pulse oximetry, and capnography)
along with the additional parameters RAM and SedLine. RAM and SedLine
were not visible to the care teams in part one of the study (standard)
but were visible to the care teams in part two of the study (advanced).
Alarm events were defined as desaturation (SpO2 ≤92%),
acoustic respiration rate ≤8 breaths per minute, and PSI ≤50.
Data were analyzed from 90 patients (44 standard and 46 advanced). There
were 55% fewer alarm events in advanced patients compared with standard
patients (median 2.5 vs. 5.5, p=0.038). Fewer advanced patients had ≥1
respiratory depression event (17 vs 26; p=0.035) or ≥1 desaturation
event (15 vs 25; p=0.02).
The investigators also compared respiratory rate events between
capnography (using the Covidien Capnostream™ 20p) and RAM in the
standard group and conducted a retrospective analysis to determine the
true positive rates for capnography and RAM. The true positive rates
were 30% and 78% respectively; the false positive rates were 70% and 22%
respectively.
There were no significant differences between groups in the number of
deeper than intended sedation events using SedLine.
The authors concluded that “the use of advanced monitoring during
planned moderate sedation was associated with fewer alarm events,
patients experiencing desaturation, and patients experiencing
respiratory depression alarm events. … The findings of this pilot study
suggest that further study into the safety and outcome impacts of
advanced monitoring during procedure-related sedation is warranted.”
For more information on RAM and SedLine, go to www.masimo.com.
@MasimoInnovates
| #Masimo
1 Applegate RL II, Lenart J, Malkin M, Meineke MN, Qoshlli S, Neumann M,
Jacobson JP, Kruger A, Ching J, Hassanian M, Um M. Advanced Monitoring
Is Associated with Fewer Alarm Events During Planned Moderate
Procedure-Related Sedation: A 2-Part Pilot Trial. Anesth Analg. 2016 Feb
1. [Epub ahead of print].
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 by taking noninvasive monitoring to new sites
and applications. 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. The benefits of Masimo SET® have
been proven in more than 100 independent and objective studies and it is
estimated to be used on more than 100 million patients in leading
hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index
(PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate,
and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive
open architecture patient monitoring and connectivity platform designed
to speed the pace of innovation and reduce the cost of care. Masimo is
also taking an active leadership role in mHealth with products such as
the Radius-7™ wearable patient monitor and the MightySat™ fingertip
pulse oximeter. Additional information about Masimo and its products may
be found at www.masimo.com.
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’s rainbow® Acoustic Monitoring (RAM™) and
SedLine® brain function monitoring technologies. 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 Root® with SedLine® and RAM™, contribute to
positive clinical outcomes and patient safety; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions with comparable accuracy and unique advantages,
including: immediate and continuous results that enable earlier
treatment without causing invasive trauma in all patients and in every
clinical situation; 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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Source: Masimo
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com