Masimo Corporation · NASDAQ:MASI
Masimo — Technical Presentation (2013)
66 slides from Masimo's technical presentation, Nov 16, 2013
Slide 1: SedLine Brain Function Monitoring
SedLine® Brain Function Monitoring
Slide 2: Anesthesia Practice Overview: Challenges and Trends
Anesthesia Practice Overview: Challenges and Trends
Slide 3: Changing trends in surgical procedures
Changing trends in surgical procedures • Ambulatory surgical procedures in community hospitals grew 12% during the period from 1990 to 20031 • In 2003, 63% of all surgical procedures performed in community hospitals were outpatient procedures1 • The ratio of patients undergoing ambulatory surgery is
Slide 4: Demographic changes have resulted in increased surgical procedures
Demographic changes have resulted in increased surgical procedures on patients with accrued… Comorbid illnesses more presurgical medications Advanced age greater sensitivities to anesthetics Cardiac disease more unstable hemodynamics Diabetes diminished autonomic responses …Leading to the in
Slide 5: The practice of anesthesiology
The practice of anesthesiology • Evaluate patient – Patient health assessment – Surgical procedure • Select appropriate agents for: – Movement—paralysis – Pain—analgesia – Loss of consciousness—sedation/amnesia • Monitor patient – Autonomic indicators – Somatic indicators
Slide 6: The objectives of general anesthesia
The objectives of general anesthesia The aim of general anesthesia is to administer a balance of agents that achieves appropriate levels of the following: Movement Unconsciousness • Amnesia Pain • Sedation
Slide 7: Current monitoring practices in anesthesiology
Current monitoring practices in anesthesiology Routine measures Common, but not Patient stability routine • Oxygenation • Precordial or esophageal auscultation Patient stability • Body temperature • Cardiac output • Urine output • Transesophageal • HR/BP echocardiography • ECG Anesthesia level Anest
Slide 8: The practice of anesthesiology
The practice of anesthesiology Select Monitor Appropriate Autonomic agents and somatic indicators Expectation Movement Unconsciousness of an uneventful • Amnesia anesthesia • Sedation Pain outcome
Slide 9: General anesthesia: A complex balance
General anesthesia: A complex balance1 c t ion r o d u et P q ui os is o f al pn g i c Hy sur ld e s ia fie A mn s io n p p r es s Su stres Sparingly of n se p o Monitored res ainful to p uli stim Extensivel y Monitored 1. Rosow C. Refresher course at the 8th Annual Anesthesia Symposium; April 21, 2
Slide 10: Could monitoring sedation improve anesthesia outcomes?
Could monitoring sedation improve anesthesia outcomes? Monitoring can improve outcomes during intubation and maintenance with respect to these factors1: • The percent of time spent within an optimal range of anesthesia • Information available regarding patient status (e.g., assist surgical team at c
Slide 11: Could monitoring sedation improve anesthesia outcomes? (cont)
Could monitoring sedation improve anesthesia outcomes? (cont) Monitoring can improve outcomes upon emergence by decreasing these factors1: • Time to extubation • Time to responsiveness • Time to post-anesthesia care unit (PACU) discharge eligibility • The % of outliers (patients requiring >15 min to
Slide 12: Does it make sense to monitor level of sedation during anesthesia?
Does it make sense to monitor level of sedation during anesthesia? Anesthesia Continuum Lighter Ideal Deeper • Increased risk of •Anesthesia is optimized; •Impaired respiratory patient anxiety and patient does not have pain and cardiovascular stress responses or movement functioning •Increased risk
Slide 13: Do anesthesiologists feel they need a new approach to monitoring?
To what extent do anesthesiologists feel that they need a new approach to monitoring anesthesia? •“Nothing wrong with what I do today…” •“Happy with rate of recovery…” •“There are no consequences of prolonged recovery…err on the deep side…” •“Everyone is asleep at 2x MAC” •“I rely on adequate drug d
Slide 14: A timeline of change
A timeline of change… Move to short-acting anesthetics isoflurane alfentanil desflurane remifentani atracurium propofol sevofluran l vecuroniu dexmedetomidin e m e 1980s 1990s 2000s Capnography BISTM SedLine® Pulse Monitor Monitor oximetry PSA 4000TM Digital Monitor ECGs Increased monitoring
Slide 15: Quantifying anesthetic depth on the brain
Quantifying anesthetic depth on the brain, the end-organ of anesthesia Using a monitoring tool that directly assesses the brain’s response to anesthetics provides an excellent prediction of a patient’s loss of consciousness and enables more accurate titration.1 1. Glass PS et al. Anesthesiology. 199
Slide 16: What constitutes an ideal brain function monitor?
What constitutes an ideal brain function monitor? Correlates with clinical measures of sedation Provides quantitative and titration independent information about of agent used patients’ sedation Reliable indicator of LOC/ROC Supports decision making Ideal brain function • Easy to set up and use moni
Slide 17: How could a brain function monitor benefit my practice?
How could a brain function monitor benefit my practice? • Contribute objective, real-time information on end-organ response to anesthesia • Introduce information that has adjunctive value during key decision points • Enable you to have more precision and control in the assessment of the anesthesia s
Slide 18: How does brain function monitoring improve patient outcomes?
How does brain function monitoring improve patient outcomes? Enhance postoperative recovery through the following: •Better orientation on arrival in post- anesthesia care unit (PACU)¹ •Earlier discharge eligibility from the PACU¹ •Less postoperative nausea and vomiting (PONV)¹ •Faster return of cogn
Slide 19: A continued evolution in the type and monitoring of anesthetics
A continued evolution in the type and monitoring of anesthetics for expanding anesthesia and critical care market As anesthesiologists have moved toward the use of short-acting anesthetics, (Propofol and now Remifentanil) with TIVA, TCI; the practice of monitoring anesthetic depth, device safety and
Slide 20: Introduction to SedLine Monitor
Introduction to SedLine® Monitor Enhancing Information, Optimizing Outcomes
Slide 21: SedLine Patient Module: Delivering high-quality, uncorrupted EEG data
SedLine® Patient Module: Delivering high-quality, uncorrupted EEG data • Resistant to electrosurgical interference, including interference from cautery • Provides uncorrupted EEG data at critical junctures – Induction and emergence – Monitoring responses to noxious stimuli • In cases of a compromise
Slide 22: The SedLine System: Scientific Background
The SedLine® System: Scientific Background • SedLine Sensor electrode is engineered for better data collection and ease of use • Provides SedLine with high-quality EEG signals • Data acquisition system includes these components: – SedLine Sensor – Patient Cable – Patient Module/amplifier – Artifact
Slide 23: SedLine Sensor: Engineering Background
SedLine Sensor: Engineering Background • Ensures that high-quality EEG signals are collected • Utilizes 4 active leads – Collects higher volume of EEG data than arrays with single active lead – Positioned to maximize capture of EEG activity in key areas of frontal lobe • Reduces preparation time thr
Slide 24: 4 simultaneous channels of EEG
4 simultaneous channels of EEG • Monitor changes in multiple parts of the brain, allowing you to react more rapidly and completely to 4 Active Leads unexpected outcomes • Highly accurate EEG data from 4 key areas in the frontal and prefrontal lobes • Expands the scope of real-time data Image is used
Slide 25: SedLine brain function monitor Benefits
SedLine® brain function monitor Benefits • A true, 4-channel EEG brain function monitor that provides objective insight into the depth of anesthesia and sedation • Expands the scope of real-time data and improves the management of the anesthetic case • High-quality EEG data plus a sophisticated algo
Slide 26: Patient State Index (PSI)
Patient State Index (PSI™): Facilitating the early detection of patient status • The PSI value corresponds to patient’s level of sedation/anesthesia along a scale of 0 to 100 (100 = fully awake). • Reflects loss/return of consciousness, arousals, emergence, and response to noxious stimuli. • Color-c
Slide 27: PSI Interpretation
PSI™ Interpretation • Patient State Index: The PSI is a processed EEG variable based on EEG changes over time and is updated every 1.2 seconds • The PSI may be affected by changes in – Perfusion – Pharmaceuticals – Stimulus – Temperature
Slide 28: Four screen views provide ability to view data in multiple ways
SedLine® : Four screen views provide ability to view data in multiple ways • EEG screen – 4-channel EEG yields significantly more information than monitors with fewer channels. • Patient State Index (PSI™) – Color-coded numeric values facilitate rapid assessment of patient status.* • Density Spectra
Slide 29: Root SedLine Split Screen View
Root SedLine Split Screen View
Slide 30: Root SedLine Split Screen View
Root SedLine Split Screen View Bilateral EEG EMG Trend PSI Trend Suppression Ratio Trend SEFL/SEFR Numeric Value Artifact Numeric Value & Trend & Trend Density Spectral Array/SEF Trend
Slide 31: Additional information available with all views
Additional information available with all views Electromyograph, Artifact Indicator, Suppression Ratio EMG SR ART • EMG (electromyograph): measures detected muscle activity • SR (suppression ratio): measures the percentage the EEG signal is suppressed • ART (artifact): measures the amount of inciden
Slide 32: PSI trend screen
PSI™ trend screen al 36:
Slide 33: Guidelines for the PSI
Guidelines for the PSI™ Numerics & Trend Colors 100 Light hypnotic state 75 50 General anesthesia 25 Deep hypnotic state 0
Slide 34: Clear display of electrode status
Clear display of electrode status
Slide 35: 4 Simultaneous Channels of EEG
4 Simultaneous Channels of EEG
Slide 36: Characterizing EEGs
Characterizing EEGs • Features of an EEG – Frequency – Amplitude – EEG Rhythms • Delta • Theta • Alpha • Beta
Slide 37: Adequate Sedation / Burst Suppression
Adequate Sedation Adequate Sedation Theta/alpha w/underlying delta L1 L1 R1 R1 L2 L2 R2 R2 Burst Suppression Burst Suppression • Looks like it sounds L1 • Burst of activity, followed by R1 suppression (flat, isoelectric) wave L2 • Seen in hypothermia and during R2 bypass procedures • Seen in some ne
Slide 38: EEG Waveforms
EEG Waveforms Example of EEG prior to induction. EEG may display very fast frequency and low amplitude PSI: 95 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical data
Slide 39: EEG Waveforms
EEG Waveforms PSI of 75, the EEG waves may begin to display a transition to Higher amplitude and Slower frequency PSI: 75 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical data
Slide 40: EEG Waveforms
EEG Waveforms EEG pattern demonstrates slow waves and some flat, isoelectric periods commonly referred to as "burst suppression.“ EEG may display continuing effects of Propofol during induction PSI: 15 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect
Slide 41: EEG Waveforms
EEG Waveforms Primarily slow delta waves may be present during general anesthesia. With certain anesthetics, alpha waves may be present within the delta waves as seen below. PSI: 26 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical
Slide 42: EEG Waveforms
EEG Waveforms During titration to decrease the anesthetic an emergence pattern may display. EEG may now display a transition to lower amplitude and faster frequency PSI: 67 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical data
Slide 43: EEG Waveforms
EEG Waveforms EEG patterns may change quickly as anesthesia is discontinued and the patient continues to awaken. Both EEG and EMG may display faster frequencies PSI: 78 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical data
Slide 44: EEG Waveforms
EEG Waveforms Fast frequency waves indicate the end of general anesthesia. Because of residual anesthetics, the display may not look exactly like pre-induction EEG PSI: 92 Amplitude: 5 uV/mm Screens shown are for illustrative purposes only EEG displayed does not reflect clinical data
Slide 45: Density Spectral Array: Monitoring the symmetry of sedation
Density Spectral Array (DSA): Monitoring the symmetry of sedation • Simultaneously compares bi-hemispheric EEG intensity, enabling immediate detection of asymmetrical activity – Asymmetrical bi-hemispheric activity tends to precede changes in anesthetic state • Capable of identifying early activity
Slide 46: Density Spectral Array: How Can It Be Used?
Density Spectral Array: How Can It Be Used? • Confirms the reliability of the PSI without being an EEG expert* • Improves the sensitivity to visualize subtle brain state changes to improve decisions on patient’s response to drug administration • Easily identifies asymmetrical EEG differences, which
Slide 47: DSA screen
DSA screen 1HR 1:45 AM 2:00 AM 2:15 AM 2:30 AM te — AW | 2:15AM 2:20 aon 2:25 AM 2:30AM DSA Te TE o
Slide 48: Asymmetry during rewarming phase – coming off pump
Asymmetry during rewarming phase – coming off pump Burst Suppression Re-warming phase Right sided
Slide 49: Spectral Edge Frequency (SEF)
Density Spectral Array Spectral Edge Frequency (SEF) • SEF identifies the point where 95% of the power in the EEG is below – The higher the SEF generally means the lighter the patient – The lower the SEF the generally means the deeper the patient
Slide 50: Scientific foundation for the PSI algorithm
Scientific foundation for the PSI™ algorithm • SedLine® is based on an algorithm developed by the Brain Research Laboratory at New York University School of Medicine – Drawn from a multivariate discriminant analysis of EEG data* • This same technique has already been used to identify changing EEG si
Slide 51: PSI algorithm: Providing clinically accurate, reliable, real-time data
PSI™ algorithm: Providing clinically accurate, reliable, real- time data • Empowers SedLine® to assess anesthetic depth with unsurpassed accuracy • Based on multivariate discriminant analysis of EEG data developed at NYU School of Medicine • Relies on comparisons against databases of patient EEG dat
Slide 52: PSI sub-algorithms: Enabling rapid response to patient state
PSI™ sub-algorithms: Enabling rapid response to patient state • Multiple sub-algorithms enhance the sensitivity of PSI algorithm to changes in activity – Early detection of critical EEG activity patterns – “Arousal observer” sub-algorithm detects subtle changes in EEG that signify decreasing sedatio
Slide 53: SedLine: Design and validation studies
SedLine® : Design and validation studies • Retrospective, developmental study* to identify appropriate EEG descriptors • Volunteer study* to collect data and demonstrate optimization with various regimens • Multicenter study* to establish safety and clinical utility • Frontal PSI algorithm developme
Slide 54: VARETA Analysis SedLine
VARETA Analysis SedLine® Slide 1: (PSI=41) Immediately after induction bolus, midline Beta wave activity is decreasing with no current abnormal prefrontal Beta wave activity. Slide 2: (PSI=61) Depicts increase in symmetrical prefrontal (L2, R2) Beta wave activity during a transition phase towards an
Slide 55: Volunteer study to gauge effects of anesthesia
Volunteer study to gauge effects of anesthesia • Brain activity in response to sedation/anesthesi a – Drop in activity follows a predictable pattern – As the brain falls asleep, EEG activity declines according to a specific, invariant pattern¹ – When waking up, EEG activity increases across the brai
Slide 56: SedLine Algorithm Development
SedLine® Algorithm Development Global brain changes to induction and emergence consistent or “invariant” across different anesthetics Conscious Cogn. 2001;10:165-183. Prichep LS, John ER, Gugino LD, Kox W, Chabot RJ. Quantitative EEG Assessment of Changes in the Level of Sedation/Hypnosis during Sur
Slide 57: Multicenter study to demonstrate clinical efficacy
Multicenter study to demonstrate clinical efficacy • PSI™ facilitates more individualized titration – PSI-directed titration of anesthesia resulted in significantly faster emergence¹ – PSI-directed titration of anesthesia resulted in significantly faster recovery¹ 1. Drover DR et al. Anesthesiology.
Slide 58: Multicenter study to demonstrate clinical efficacy (cont)
Multicenter study to demonstrate clinical efficacy (cont) • PSI™-directed titration showed high sensitivity upon emergence¹ – Both PSI and BIS values correlated with the end-tidal concentration of desflurane at eye-opening and at tracheal extubation – Correlation coefficients were consistently highe
Slide 59: Benefits for At-Risk Populations
Benefits for At-Risk Populations
Slide 60: What subpopulations are most likely to benefit from level-of-sedation monitoring?
What subpopulations are most likely to benefit from level-of- sedation monitoring? • Patients who experience unpredictable responses to anesthesia – Elderly – Those with serious – Pediatric comorbid illnesses – Trauma – Significantly allergic – Morbidly obese – ETOH/substance abusers
Slide 61: SCCM Guidelines for Cerebral Monitors
SCCM Guidelines for Cerebral Monitors • We suggest that objective measures of brain function (e.g., auditory evoked potentials [AEPs], Bispectral Index [BIS], Narcotrend Index [NI], Patient State Index [PSI], or state entropy [SE]) be used as an adjunct to subjective sedation assessments in adult IC
Slide 62: SCCM Guidelines for Cerebral Monitors
SCCM Guidelines for Cerebral Monitors • We recommend that EEG monitoring be used to monitor nonconvulsive seizure activity in adult ICU patients with either known or suspected seizures, or to titrate electrosuppressive medication to achieve burst suppression in adult ICU patients with elevated intra
Slide 63: Patient State Index During a Cardiac Arrest in the Operating Room
Patient State Index During a Cardiac Arrest in the Operating Room Ngo K. Nguyen, MD, Fima Lenkovsky, PhD, MD, and Girish P. Joshi, MB, BS, MD, FFARCSI Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, Texas; and Dallas Veterans Affairs Medic
Slide 64: Future Directions for EEG Monitoring
Future Directions for EEG Monitoring
Slide 65: Current and future applications for level-of-sedation monitors
What are the current and future applications for level-of- sedation monitors? Current • Hospital and ambulatory settings using general anesthetics • ICU sedation in ventilated patients Future (undergoing research & development) • Conscious sedation – Cardiovascular procedures (e.g., angiography, ang
Slide 66: Thank You
Thank You