New Study Evaluates the Ability of Masimo SedLine® Brain Function Monitoring to Predict Neurological Outcomes & Long-term Su...
July 06 2021 - 2:00AM
Business Wire
Researchers Found That the Combination of Two
SedLine Parameters, Patient State Index (PSi) and Suppression Ratio
(SR), Had High Predictability for Mortality 180 Days After Cardiac
Arrest
Masimo (NASDAQ: MASI) announced today the findings of a study
published in the Journal of Critical Care in which Dr. Tae Youn Kim
and colleagues at the Dongguk University College of Medicine and
Yonsei University College of Medicine in Korea evaluated the
ability of two parameters provided by Masimo SedLine® brain
function monitoring to predict neurological outcomes and long-term
survival in post-cardiac arrest ICU patients.1 The researchers
found that the combination of the two parameters, Patient State
Index (PSi) and Suppression Ratio (SR) had “high predictability”
for mortality 180 days after cardiac arrest.
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Masimo SedLine® Brain Function Monitoring
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Noting that “accurate prognostication” in post-cardiac arrest
patients is important to determine treatment plans and “whether to
continue or withdraw intensive care,” and that a “multi-modal”
approach is recommended because “no single prognostic factor has
been shown to have higher prognostic accuracy than those of other
factors,” the researchers sought to evaluate the prognostic
accuracy of the two Masimo SedLine parameters as predictors of
neurological outcomes, both alone and in combination. The
researchers chose PSi because, as they note, raw EEG data can be
“difficult to use” and PSi, which is derived from EEG, is widely
used in anesthesiology for determining the degree of procedural
sedation, “significantly co-varies with changes in the state” under
general anesthesia, and “can significantly predict” the level of
arousal in varying stages of anesthetic delivery. The researchers
chose SR because it helps to estimate the percentage of EEG
suppression and is therefore considered a good predictor of poor
neurologic outcomes.2
They enrolled 103 adult patients between January 2017 and August
2020 who experienced a non-traumatic out-of-hospital cardiac
arrest, had been successfully resuscitated after CPR, and received
targeted temperature management during their ICU stay. PSi and SR
were continuously monitored using Masimo SedLine from immediately
after ICU admission until 24 hours after return of spontaneous
circulation (ROSC), recorded at one hour intervals. Neurological
outcomes were categorized using the Pittsburgh Brain Stem Score
(PBSS) and Cerebral Performance Category (CPC). Data on survival at
180 days was obtained via telephonic interviews.
The researchers found that using either PSi or SR alone had
“good predictability” for poor neurological outcome, and that the
combination of low PSi and SR had “high predictability” for
mortality 180 days after cardiac arrest. They used receiver
operating characteristic (ROC) curves to determine that “a mean PSI
≤ 14.53 and mean SR > 36.6 showed high diagnostic accuracy” as
single prognostic factors for patients in their study. Furthermore,
“Multimodal prediction using the mean PSi and mean SR showed the
highest area-under-the-curve value of 0.965 (95% confidence
interval 0.909–0.991).” In the study cohort, patients with mean PSi
≤ 14.53 and mean SR > 36.6 had “relatively higher long-term
mortality rates” (69% died in the group) than those of patients
with values > 14.53 and ≤ 36.6 (11% died in the group).
The researchers concluded that “PSi and SR are good predictors
for early neuro-prognostication in post-cardiac arrest patients.”
They also noted, “The combination of PSI and SR showed better
predictability of poor neurologic outcome than did each individual
parameter.”
@Masimo | #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,
reduce the cost of care, and take noninvasive monitoring to new
sites and applications. 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.3 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,4 improve CCHD screening in newborns,5 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.6-9 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,10 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.11 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,
iSirona™, 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
- Kim TY, Hwang SO, Jung WJ, et al. Early neuroprognostication
with the Patient State Index and suppression ratio in post-cardiac
arrest patients. J Crit Care. 2018.
https://doi.org/10.1016/j.jcrc.2020.06.003.
- Seder DB, Fraser GL, Robbins T, Libby L, Riker RR. The
bispectral index and suppression ratio are very early predictors of
neurological outcome during therapeutic hypothermia after cardiac
arrest. Intensive Care Med 2010;36(2):281-8.
- 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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