Researchers Found That O3 May Help Clinicians
Rapidly Assess Circulatory Status in Patients Experiencing Septic
Shock and Have Prognostic Value in Mortality Prediction
Masimo (NASDAQ: MASI) announced today the findings of a study
published in the Journal of Anesthesia & Clinical Research in
which Dr. Debdipta Das and colleagues at Medical College Kolkata in
India evaluated the utility of Masimo O3® Regional Oximetry to aid
in monitoring septic shock patients admitted to the ICU.1 O3,
available on the Masimo Root® Patient Monitoring and Connectivity
Platform, uses noninvasive near-infrared spectroscopy (NIRS) to
enable monitoring of regional oxygen saturation (rSO2) in the
region of interest, such as the brain or cerebral tissue (CrSO2).
The researchers found that O3 trends correlated significantly with
a variety of other hemodynamic variables and lactic acid levels
commonly used in the monitoring of septic shock patients. They also
found rSO2 values differed significantly between patients who
survived and those who did not, suggesting it may have value as a
predictor of mortality in septic shock patients.
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Masimo Root® with O3® Regional Oximetry
and SedLine® Brain Function Monitoring (Graphic: Business Wire)
Noting the value of assessing tissue perfusion to aid in the
management of hemodynamically challenged ICU patients, the
researchers sought to evaluate whether noninvasive cerebral
regional oxygen saturation monitoring might prove a viable adjunct
or alternative to methods that may be affected by the patient’s
baseline condition (such as vital signs monitoring) and invasive
methods (like blood lactate measurement), which carry a host of
limitations (intermittent and delayed measurement, blood loss,
etc.). To do so, they monitored 40 adult patients, diagnosed with
septic shock and admitted to the Critical Care Unit, with Masimo O3
and a variety of other measurements every six hours for 72 hours
after admission.
The researchers found that O3 cerebral oxygenation trends
correlated significantly with other parameters commonly used in
monitoring septic shock patients. There was a significant negative
correlation between cerebral rSO2 and lactic acid (r = -0.749 to
-0.956) after the first six hours after admission. They also found
significant positive correlations between cerebral rSO2 and central
venous saturation (r = 0.904 to 0.993), mean arterial pressure (r =
0.957 to 0.993), and arterial oxygen saturation (r = 0.864 to
0.988).
Notably, the researchers found that survivors (n = 29) had a
significant difference in cerebral rSO2 over the 72 hours after
admission compared to non-survivors (n = 11) (p < 0.001),
suggesting that O3 rSO2 measured on cerebral tissue may have
predictive value for mortality in septic shock patients.
As part of the study, patients with cerebrovascular stroke,
cerebral infarction, cerebral hemorrhage, convulsions, or paresis,
as well as patients with a more than 10% difference in rSO2 values
between the two sides of the brain, were excluded.
The researchers concluded that Masimo O3 rSO2 on cerebral tissue
“could be [a] parameter in patients with shock and it could have a
prognostic value in mortality prediction and clinical outcome.”
They elaborated, “In the current study, we highlight other new
advantages of NIRS monitoring in circulatory shock (septic) as a
continuous monitor and as an outcome predictor. The most important
observation from this study is the significant correlation between
NIRS oximetry readings and hemodynamic variables, especially lactic
acid [and] central venous oxygen saturation in patients
experiencing shock. These data, therefore, propose a method for
rapid and noninvasive assessment of circulatory status in patients
experiencing shock.”
@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.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.5-8 Masimo SET® is estimated to be used on more than 200
million patients in leading hospitals and other healthcare settings
around the world,9 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.10 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
- Das D, Mitra K, Das S. Brain CO-Oximetry: A Useful Noninvasive
Parameter Adjuvant to Standard Perfusion Parameters in Septic
Shock. J Anesth Clin Res. 12(1)987.
- 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 O3®. 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 O3, 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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