New Study Compares Performance of Masimo Next Generation SedLine® Patient State Index (PSi) to Original PSi During Anesthesia
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Masimo RD SedLine® Adult EEG Sensor (Photo: Business Wire)
SedLine brain function monitoring features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, four EEG waveforms, a Density Spectral Array (DSA, an easy-to-interpret, high-resolution display of bi-hemispheric activity and EEG power), and PSi. Next Generation SedLine enhances PSi to make it less susceptible to electromyographic (EMG) interference and to improve its performance in low-power EEG cases.
In the study, Dr. Kuizenga and colleagues sought to compare the original and Next Generation PSi algorithms, referred to as PSi-1 and PSi-2, respectively, as they correlated with propofol and sevoflurane drug concentrations and with the Modified Observers Assessment of Alertness and Sedation (MOAAS) scale. They also sought to assess the influence of 2 and 4 ng/mL effect-site concentrations of remifentanil on the performance of the two algorithms.
The researchers enrolled 36 healthy volunteers, stratified by age, and
assigned them randomly to a sequence of four sessions of anesthesia. In
one session, propofol was administered in a series of graded steps; in
the second, sevoflurane was similarly administered; in the third and
fourth, the two concentrations of remifentanil were also administered.
During each step of each session, after a twelve-minute delay for
equilibration, MOAAS was tested and a blood sample was taken to measure
drug concentrations. EEG was collected using
The researchers found that when charted against drug concentrations, PSi-2 showed “reduced population variability and improved baseline stability” compared to PSi-1. When charted against MOAAS, PSi-2 had “lower interindividual variability” than PSi-1. They also noted that “Both PSis distinguish MOAAS 5, 4, and 3 better during propofol anesthesia compared to sevoflurane. This difference disappears when adding remifentanil.”
The investigators concluded that “PSi-2 [Next Generation SedLine PSi] has enhanced signal stability and a better description of the dose-response relationship. PSi-2 has therefore improved capacity as a pharmacodynamic monitor of anesthesia compared to PSi-1.”
Next Generation SedLine has not received
@MasimoInnovates | #Masimo
Kuizenga M.H., Colin P.J., Vereecke H.E.M., Struys M.M.R.F. Comparison
between two versions of the Patient State Index during propofol and
sevoflurane anesthesia, with or without remifentanil. Proceedings from
Geneva, Switzerland. Abstract #01AP07-4.
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive
monitoring technologies. Our mission is to improve patient outcomes and
reduce the cost of care. In 1995, the company debuted Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, which has been
shown in multiple studies to significantly reduce false alarms and
accurately monitor for true alarms. Masimo SET® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 and is the primary pulse oximetry at 16 of the top 20
hospitals listed in the 2016-17
*The use of the trademark Patient SafetyNet is under license from
- 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;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 AH 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.
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; as well as other factors
discussed in the "Risk Factors" section of our most recent reports filed
Evan Lamb, 949-396-3376