Masimo (NASDAQ: MASI) announced today that in a study recently
published in Anesthesia & Analgesia, researchers investigated
the incidence of isoelectric electroencephalogram (EEG) events in
infants and young children undergoing scheduled surgery requiring
general anesthesia.1 To assess the prevalence of these events, the
researchers used Masimo SedLine® brain function monitoring,
available on the Root® Patient Monitoring and Connectivity
Platform, which uses four leads and bilateral data acquisition to
process frontal EEG signals. Because a subset of patients was also
monitored with 10-channel EEG, the researchers were able to
evaluate SedLine’s accuracy and utility in such a scenario.
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Dr. Ian Yuan and colleagues at the Children’s Hospital of
Philadelphia, the University of Pennsylvania, and Drexel University
sought to evaluate the incidence of isoelectric EEG events in
pediatric patients because anesthetic doses may be “greater than
needed for surgery” in some infants and young children and
isoelectric EEG events are associated with deep anesthesia (and in
adults undergoing cardiac surgery, with “a higher incidence of
postoperative delirium”). They evaluated 51 patients from 0 to 37
months old scheduled for surgery requiring general anesthesia
(excluding cardiac, intracranial, and emergency cases). Anesthesia
was maintained with sevoflurane or propofol infusion.
Noting that “Conventional 10- to 24-channel EEG is impractical
for pediatric anesthesia as it is labor intensive and requires
special training in both performance and interpretation,” the
researchers chose to record EEG for the duration of anesthesia
using Masimo SedLine. To evaluate whether isoelectric events were
generalized beyond the frontal cortex, they also recorded
simultaneous data using 10-electrode EEG (Natus Xltek) for 10
patients (2-10 months old). Isoelectric events were defined as EEG
with amplitude <20 μV for ≥2 seconds.
The researchers found that isoelectric events occurred in 63% of
patients (95% confidence interval of 49% - 76%), representing 0% -
2.2% of total anesthetic time. A pediatric electroencephalographer
compared the EEG recordings for 9 of the 10 patients monitored with
both SedLine and 10-channel EEG and found that isoelectric events
observed with SedLine were also observed across all channels with
10-channel EEG, noting “The Matlab program identified 47
isoelectric events from the SedLine EEG, and all events were
confirmed by the electroencephalographer.”
Dr. Yuan commented, “We were surprised by how prevalent
isoelectric EEG occurred in healthy infants and young children
undergoing routine general anesthesia, regardless of anesthetic
technique. The Masimo SedLine EEG could be applied quickly without
interfering with anesthesia care and could accurately record EEG in
infants and young children in the operating room, suggesting it
could be used to adjust anesthesia dosing.”
Study co-author Dr. C. Dean Kurth added, “Pediatric
anesthesiologists often unknowingly administer more sevoflurane or
propofol anesthesia to infants and young children than their brain
requires to produce anesthesia.”
Regarding the use of SedLine, the researchers concluded,
“Although the SedLine EEG monitors only frontal cortex, the
10-electrode EEG showed that the isoelectric events were
generalized to the parietal, temporal, and occipital cortices as
well, suggesting that the SedLine EEG could be used to monitor
anesthetic-related isoelectric events.” They continued, “EEG
monitoring may enable dose titration to optimize the anesthetic
depth and minimize periods of isoelectricity. Our results suggest
that portable 4-channel EEG monitors are feasible for this
purpose.” With SedLine, periods of isoelectricity, or burst
suppression, are easily visible on the Density Spectral Array
(DSA), a color-coded display of processed EEG power, as black
bars.
SedLine and Next Generation SedLine have received FDA clearance
for use on adult patients. Next Generation SedLine has received CE
marking for use on pediatric patients (one year old and above).
@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 100 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 listed in the 2018-19 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 Doctella™. 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.
References
- Yuan I, Landis W, Topjian A, Abend N, Lang S, Huh J, Kirschen
M, Mensinger J, Zhang B, and Kurth C. Prevalence of Isoelectric
Electroencephalography Events in Infants and Young Children
Undergoing General Anesthesia. Anesth Analg. 2019. DOI:
10.1213/ANE.0000000000004221
- 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 SedLine®. 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 SedLine, 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.
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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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