Masimo SedLine® Brain Function Monitoring with
PSi Processed EEG Helped Identify the Oversedations
Masimo (NASDAQ: MASI) today announced that in a new study
published in Anesthesia Research and Practice, researchers used
Masimo SedLine® Brain Function Monitoring to investigate the depth
of anesthesia of patients receiving propofol for outpatient
colonoscopy, concluding that, “Although providers planned for
moderate to deep sedation, processed EEG [electroencephalography]
showed patients were under general anesthesia, often with burst
suppression. Anesthesiologists and endoscopists may utilize
processed EEG to recognize their institutional practice patterns of
procedural sedation with propofol and improve upon it.”
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Masimo SedLine® Brain Function Monitoring
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Noting that depth of sedation is “rarely quantified,” but that
“the spectrum of sedation actually attained in gastrointestinal
endoscopy procedures may extend to levels deeper than planned for,
thereby exposing patients to…cardiorespiratory risks,” Dr. Jamie
Bloom and colleagues at Thomas Jefferson University Hospital in
Philadelphia sought to understand how frequently patients whose
procedures called for moderate to deep sedation using propofol
actually experience unintended general anesthesia and burst
suppression. To quantify this, they monitored 119 adult patients
undergoing outpatient colonoscopies using Masimo SedLine brain
function monitoring, including its processed EEG index, the Patient
State Index (PSi). PSi provides values that range from 0 to 100,
with higher values indicating lesser degrees of sedation (with
values from 50 to 25 indicative of general anesthesia, and below 25
for burst suppression). For the study, PSi values correlating to
general anesthesia and burst suppression were confirmed by
examination of the raw EEG by a neurointensivist and a
neurophysiologist.
The researchers found that 118 of the 119 (99.1%) patients
attained PSi values of <50, consistent with general anesthesia,
and that these patients spent a significantly greater percentage of
the procedure with PSi values <50 (53.1% of the time) vs. >50
(42% of the time) (p = 0.001). Of the 118 patients, 33 (27.7%)
attained PSi values of <25, consistent with burst suppression.
In addition, the researchers found the mean total dose of propofol
was significantly correlated with PSi during periods of PSi values
<25 (R = 0.406, p = 0.021).
Based on the study results, the researchers concluded, “The
depth of sedation achieved with anesthesia administered propofol
for colonoscopy spans a continuum. Although providers planned for
moderate to deep sedation, processed EEG in this study revealed a
substantially greater depth consistent with general anesthesia and
even burst suppression.”
They continued, “Feedback from devices such as employed in this
study to guide the depth of sedation may be considered to not only
raise awareness of the physiologic implications of deeper levels of
sedation but also to optimize institutional sedation practice.
Further research is required to establish the impact on patient
outcomes of anesthetic practices resulting in intraprocedural burst
suppression.”
Patients receiving anesthesia during surgery can be over- or
undersedated, both of which carry risks. When under-anesthetized,
patients may have awareness during the procedure, which can be
traumatic; when they are over-anesthetized, they may have
alternating periods of no brain activity as measured by EEG, which
is referred to as burst suppression.2 Burst suppression has been
correlated with increased risk of postoperative delirium,3 which in
turn has been shown to increase hospital length of stay and
readmission rates, thus increasing costs.4 Burst suppression has
also been associated with postoperative trauma, dementia, decreased
quality of life, additional healthcare costs, and even death.3 In
addition to burst suppression, overly deep sedation may result in
loss of spontaneous ventilation and impaired cardiovascular
function.1 Oversedation has also been associated with longer time
on mechanical ventilation, longer time in the ICU, greater need for
radiological evaluation of mental status, and a higher probability
of developing brain dysfunction.2
The role of anesthesiologists in keeping patients appropriately
sedated, and not over- or under-sedated, is critically important.
Masimo SedLine has been shown to help anesthesiologists understand
the patient’s sedation state using not only PSi values, but also
through interpretation of the raw EEG and the Density Spectral
Array that SedLine provides.4-6 In the current study, researchers
showed that even in outpatient procedures, like colonoscopy, there
is still a risk of patients being over-anesthetized, leading to
burst suppression, which was identified using the PSi available as
part of Masimo SedLine brain function monitoring.1
@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.7 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,8 improve CCHD screening in newborns,9 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.10-13 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,14 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.15 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
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, 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.
References
- Bloom J, Wyler D, Torjman M, Trinh T, Li L, Mehta A, Fitchett
E, Kastenberg D, Mahla M, Romo V. High Incidence of Burst
Suppression during Propofol Sedation for Outpatient Colonoscopy:
Lessons Learned from Neuromonitoring. Anesthesiology Research and
Practice. 2020;7246570. https://doi.org/10.1155/2020/7246570.
- Hughes, C, McGrane S, Pandharipande P. Sedation in the
intensive care setting. Clinical pharmacology: advances and
applications 4 (2012): 53.
- Fritz, B et al. Intraoperative electroencephalogram suppression
predicts postoperative delirium. Anesth Analg. 122.1 (2016):
234.
- Hesse S et al. Association of electroencephalogram trajectories
during emergence from anaesthesia with delirium in the
postanaesthesia care unit: an early sign of postoperative
complications. BJA 122.5 (2019): 622-634.
- Purdon P et al. Clinical electroencephalography for
anesthesiologists part I: background and basic signatures.
Anesthesiology. 123.4 (2015): 937-960.
- Sayed E, Refaat E, Yassen K. SedLine Monitored Sedation and
Recovery for Postoperative Ventilated Recipients of Living Donor
Liver Transplantation: A Randomized Controlled Trial. J Anesth Clin
Res 6.530 (2015): 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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; 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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