Study Stresses the Importance of Brain
Monitoring During the Treatment of Patients with Severe
COVID-19
Masimo (NASDAQ: MASI) today announced the results of a
prospective, observational study published in Critical Care in
which researchers in Genoa, Italy, evaluated the impact of a
variety of rescue therapies on the systemic and cerebral
oxygenation of mechanically ventilated COVID-19 patients suffering
from acute respiratory distress syndrome (ARDS).1 To gauge the
impact, the researchers used the Masimo Root® Patient Monitoring
and Connectivity Platform with O3® Regional Oximetry, which uses
near-infrared spectroscopy (NIRS) to enable monitoring of tissue
oxygen saturation (rSO2) in the region of interest, such as the
brain.
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Masimo Root® with O3® Regional Oximetry
and SedLine® Brain Function Monitoring (Photo: Business Wire)
Dr. Chiara Robba and colleagues noted that “neurological
complications are common in mechanically ventilated critically ill
patients with COVID-19 and may lead to impaired cerebral
hemodynamics,” and further, that respiratory rescue therapies “may
have detrimental effects on brain physiology.” Observing, however,
that there is currently little data available regarding the effect
of rescue therapies on these patients’ brains, and in particular on
cerebral oxygenation, the researchers sought to assess the impact
of different ventilatory rescue therapies on the brain to help
guide clinicians in choosing the most appropriate therapies for
their COVID-19 patients.
The rescue therapies studied were recruitment maneuvers (RMs),
prone positioning (PP), inhaled nitric oxide (iNO), and
extracorporeal carbon dioxide removal (ECCO2R). To assess impact,
the researchers measured (before and after the application of each
method) arterial oxygen saturation (SpO2), partial pressure of
oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), and
cerebral oxygen saturation (rSO2). rSO2 was obtained using Masimo
Root with O3, which also allowed them to observe several additional
parameters unique to Masimo O3: ΔO2Hb, which monitors relative
changes in the oxygenated hemoglobin component of rSO2; ΔHHb, which
monitors relative changes in the deoxygenated hemoglobin component
of rSO2; and ΔcHb, which monitors relative changes in total
cerebral hemoglobin or blood volume. As a secondary aim, the
researchers sought to evaluate the correlation between systemic and
cerebral oxygenation.
The researchers found that the four rescue therapies had varied
impact on cerebral oxygenation and the other measured parameters,
noting in particular that after RMs, while there was no significant
change in PaO2 or PaCO2, there was a significant decrease in rSO2.
After PP and after iNO therapies, both PaO2 and rSO2 increased;
ΔcHb also increased, corresponding to increased cerebral blood
volume. After ECCO2R, both PaO2 and rSO2 decreased.
The researchers concluded, “Rescue therapies exert specific
pathophysiological mechanisms, resulting in different effects on
systemic and cerebral oxygenation in critically ill COVID-19
patients with ARDS. … The choice of rescue strategy to be adopted
should take into account both lung and brain needs.”
They also noted, “To our knowledge, this is the first study
investigating the early effects of rescue therapies on systemic and
cerebral oxygenation and their correlation in critically ill
patients with COVID-19-associated ARDS. The use of multimodal
neuromonitoring, including new indices such as ΔHHbi + ΔO2Hbi,
enabled us to better investigate the specific consequences of each
ventilatory rescue strategy for brain and lung function. This is
particularly important, especially in the early phases after rescue
therapies application, when most of the effects on cerebral
physiology are mainly acting.”
Dr. Robba and study co-author Dr. Basil Matta, Senior Medical
Director at Masimo, commented, “The ability to observe relative
changes in oxygenated, deoxygenated, and total hemoglobin with O3’s
delta indices provided us with better insight into why brain
saturations change as a result of interventions, and allowed us to
better understand the interactions between systemic and cerebral
hemodynamics. For example, we saw that turning patients prone
resulted in improved systemic and cerebral oxygenation, whereas the
lung recruitment maneuver did not improve systemic oxygenation, and
even had an adverse effect by reducing brain oxygen
saturation.”
They continued, “Above all, the main objective of improving the
oxygen content of the blood is to deliver oxygen to vital organs,
the most important of which is the brain. Masimo O3 provides the
clinician with the ability to assess the impact of any medical
intervention aimed at improving oxygenation. O3’s hemoglobin
indices were critical to our understanding of the effects of our
interventions on the brain. Without such a monitor, we are at best
guessing, and in danger of flying blind. As we continue to seek to
improve care and outcomes for patients with severe COVID-19, any
tool that helps us better understand the impact of different
medical interventions is most welcome.”
@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 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.5-8 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
- Robba C, Ball L, Battaglini D, Cardim D, Moncalvo E, Brunetti
I, Bassetti M, Giacobbe D, Vena A, Patroniti N, Rocco P, Matta B,
Pelosi P. Early effects of ventilatory rescue therapies on systemic
and cerebral oxygenation in mechanically ventilated COVID-19
patients with acute respiratory distress syndrome: a prospective
observational study. Crit Care (2021)25:111. DOI:
https://doi.org/10.1186/s13054-021-03537-1.
- 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 Root® with 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 Root with 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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