Masimo (NASDAQ: MASI) announced today that in a study recently
published in the Journal of Clinical Monitoring and Computing,
researchers at Nippon Medical School in Tokyo, Japan used Masimo
Patient SafetyNet™ and rainbow Acoustic Monitoring® (RAM®),
acoustic respiration rate monitoring with RRa®, as a centralized
continuous monitoring system to identify the incidence and
predictors of desaturation and bradypnea in postoperative patients
– concluding that “Use of monitoring systems might provide a safety
net for postoperative patients.”1
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Masimo Patient SafetyNet™, Root® with
Radius-7®, RRa®, and SET® (Photo: Business Wire)
Patient SafetyNet is a supplemental remote monitoring, patient
surveillance, and clinician notification system that works in
conjunction with Masimo and third-party bedside monitoring devices
to display near real-time data at central stations. RAM with RRa
uses an acoustic transducer positioned on the patient’s neck to
provide noninvasive, continuous respiration monitoring.
Hypothesizing that postoperative desaturation and bradypnea
might occur even in non-ICU patients without serious complications,
and in patients who did not undergo major surgery, Drs. Masashi
Ishikawa and Atsuhiro Sakamoto set up a centralized postoperative
monitoring system in the general ward to investigate how common
these events are for such patients (and what might predict them).
They analyzed demographic and monitoring data from 1,064 adult
patients who underwent general anesthesia for various surgical
procedures over a 4-month period. The patients were monitored using
a pulse oximeter and an RRa sensor for at least 8 hours after
surgery, data which were automatically transferred to Patient
SafetyNet.
From the data stored on the Patient SafetyNet, the researchers
were able to retrospectively analyze the incidence of desaturation
(defined as SpO2 < 90% for > 10 seconds) and bradypnea
(defined as respiratory rate < 8 breaths/minute for > 2
minutes). They found that 12.1% of patients exhibited desaturation
(244 events among 129 patients), with most occurring after the
termination of oxygen administration, and 50.8% of the events
occurring more than 8 hours after surgery. They found that 5.1% of
the patients exhibited bradypnea (112 times among 54 patients),
with 72.3% of the events occurring during oxygen supplementation,
and with the greatest incidence within the first hour after
surgery. Age, body mass index, and current smoking status were
significant risk factors for desaturation. Sleep apnea syndrome and
postoperative opioid administration were significant risk factors
for bradypnea. Age and postoperative opioid administration were
significant risk factors for the combination of desaturation and
bradypnea.
The researchers concluded, “Our study suggests that use of a
continuous and centralized respiratory monitoring system for
overnight postoperatively is desirable for postoperative management
in the general ward, which would likely improve the safety of
postoperative patients, especially those with risk factors for
respiratory depression.”
The researchers commented on a number of methods of respiratory
rate monitoring, stating, “Continuous and centralized monitoring of
oxygen saturation and respiratory rate can detect respiratory
depression before it results in critical events such as cardiac
arrest. Several methods of respiratory rate monitoring are
currently used, including manual counting of breaths by a
caregiver, capnography, and transthoracic impedance measurement.
Manual counting of breaths (such as auscultation) is an
intermittent, labor-intensive and unreliable method. Capnography
provides accurate and continuous monitoring, but requires a nasal
or facial interface, which can be uncomfortable and may lead to
failure if the interface is moved. Transthoracic impedance is
non-invasive and can detect respiratory efforts, but is unable to
detect alveolar hypoventilation caused by airway
obstruction.”2-6
Additionally, the researchers commented on RAM with RRa, the
respiratory rate monitoring method used in the current study, and
referenced another study in which RRa and capnography were
compared, stating: “RRa is an acoustic monitoring device that
continuously measures respiratory rate, and is as accurate as
capnography in extubated patients.7 Patient activities, such as
talking, coughing and crying, affect the results of both RRa and
capnography. The measurement errors during these activities are,
however, not clinically relevant because they require that the
patients are awake and breathing. Further, the RRa sensor appears
to be well-tolerated and no more subject to error than
capnography.7 RRa was found to be a reliable device and had fewer
complications in this study.”
@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.8 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,9 improve CCHD screening in newborns,10 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.11-13 Masimo SET® is estimated to be used on
more than 100 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 2019-20 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 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
- Ishikawa M and Sakamoto A. Postoperative desaturation and
bradypnea after general anesthesia in non-ICU patients: a
retrospective evaluation. J Clin Monit Comput. 2 Mar 2019.
https://doi.org/10.1007/s10877-019-00293-0.
- Petterson MT, Begnoche VL, and Graybeal JM. The effect of
motion on pulse oximetry and its clinical significance. Anesth
Analg. 2007;105(6 Suppl):78–84.
- Wilkinson JN, and Thanawala VU. Thoracic impedance monitoring
of respiratory rate during sedation—is it safe? Anaesthesia.
2009;64(4):455–6.
- Cohen KP, Ladd WM, Beams DM, Sheers WS, Radwin RG, Tompkins WJ,
and Webster JG. Comparison of impedance and inductance ventilation
sensors on adults during breathing, motion, and simulated airway
obstruction. IEEE Trans Biomed Eng. 1997;44(7):555–66.
- Drummond GB, Nimmo AF, and Elton RA. Thoracic impedance used
for measuring chest wall movement in postoperative patients. Br J
Anaesth. 1996;77(3):327–32.
- Brouillette RT, Morrow AS, Weese-Mayer DE, and Hunt CE.
Comparison of respiratory inductive plethysmography and thoracic
impedance for apnea monitoring. J Pediatr. 1987;111(3):377–83.
- Mimoz O, Benard T, Gaucher A, Frasca D, and Debaene B. Accuracy
of respiratory rate monitoring using a non-invasive acoustic method
after general anaesthesia. Br J Anaesth. 2012
May;108(5):872–5.
- 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 Patient SafetyNet™
and RRa®. 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 Patient SafetyNet and RRa,
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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