The Nuts and Bolts of CPAP Use: Titration, Tracking, Optimization. Outline

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1 The Nuts and Bolts of CPAP Use: Titration, Tracking, Optimization Grace Pien, MD, MSCE Division of Pulmonary and Critical Care Department of Medicine Johns Hopkins School of Medicine 16 February 2018 Outline Optimizing CPAP delivery PAP systems Masks Accessories Troubleshooting Understanding and using tracking data PAP adherence tracking systems Residual AHI and event detection Mask leak Data transmission and review systems Barriers to using tracking systems in clinical practice How to use the data 1

2 Introduction to CPAP: What to Tell the Patient Safer than taking a medication Not a breathing machine s/he will not die if disconnected from the unit or therapy stopped Pneumatic splint to open the airway - it is not oxygen Machine much quieter than snoring - white noise Use during sleep only Consider a desensitization program Get used to it - watch TV with CPAP on Take pictures of yourself CPAP Units 2018 ResMed AirSense 10 Philips Respironics DreamStation Fisher & Paykel SleepStyle 2

3 Travel CPAPs HDM Z1 ResMed AirMini Is This the Future of CPAP? MicroCPAP microblower fluidic pump About half of capital raised from crowdfunding Still in prototype form NOT yet evaluated in clinical trials or by FDA 3

4 Cost of CPAP CPAP machines range from $300 to $800 More expensive units have compliance/efficacy capability, some have built-in auto-pap capability Auto-CPAP: $500 - $900 (no code for Medicare reimbursement) Bi-level systems: $950 - $1700 Circuit and mask $75 - $200+ New CPAP mask every 6 months should be covered Insurance companies (including BC/BS, US Health Care, Medicare, HMO's, Managed Medicaid, etc) provide coverage CPAP Advancements Ramp systems Useful at high CPAP settings Heated humidification* Multiple heated humidification systems available Reduces nasal drying - useful for mouth leaks and patients with sinus problems Cool passive humidifiers not as effective Humidifier and CPAP in one unit Heating coils in tubing Tubing insulators *AASM practice parameters CPAP/Bilevel pressure. Sleep 29: ,

5 CPAP Advancements: Variable Expiratory Pressure Different manufacturers, different names, different algorithms for pressure reduction Philips Respironics C-Flex and A-Flex Relative drop C-Flex lowers pressure on exhalation, ramps back up to the prescribed pressure at inhalation A-Flex (for Auto-CPAP) lowers pressure on exhalation, gradually increases the pressure on inhalation Resmed EPR (expiratory pressure relief) 1, 2 or 3 cm drop during exhalation, increased back to prescribed pressure at inhalation DeVilbiss Smartflex 1, 2 or 3 cm drop during exhalation, separate settings for adjustment during inhalation Useful in patients with difficulty with exhalation Equally effective as CPAP No long term effect on adherence No difference in cost Auto-CPAP These units adjust the pressure throughout night rather than delivering one fixed pressure Optimal CPAP varies during night Changes in body, head position Sleep state dependent changes REM v. NREM; effects of sleep deprivation Alcohol or sedative effects Effects of URIs, seasonal allergies Useful for bariatric surgery patients Becoming standard with widespred use of HSAT 5

6 Auto-CPAP Noninvasively detects variations of upper airway obstruction and airflow limitation Hypopneas Apneas Snoring APAP devices automatically increase pressure until flow limitation resolved Followed by gradual reduction in pressure until flow limitation resumed Maximum therapeutic range: 4 to 20 cm H 2 O Auto-CPAP: Uses and Limitations mean pressure across the night eg nasal complaints, nosebleeds Automated titration: in lab or at home Able to determine appropriate CPAP settings Allows for fewer technologists if in lab Inability to recognize central apneas and hypoventilation (may be changing) More expensive than conventional CPAP This is changing No code for medicare reimbursement 6

7 Comparison of CPAP with APAP Meta-analysis of 9 RCTS (282 patients) published between No significant difference Reduction in AHI Daytime sleepiness (Epworth Sleepiness Scale) Adherence Significant reduction in mean pressure (2.2 cm water) with APAP Conclusions: CPAP should remain the primary treatment option for patients with OSA Ayas et al, Sleep 27; , 2004 Bilevel Positive Airway Pressure Several different commercially available bilevel systems Independent regulation of inspiratory (IPAP) and expiratory (EPAP) airway pressures Lower expiratory pressures May be useful for patients who have difficulty with exhalation or chest pain with CPAP Algorithms to adjust pressures are empiric Increase EPAP or IPAP or both? Role of IPAP and EPAP in abolishing apneas needs to be studied Auto-Bilevel PAP systems - how do they work? The pressure differential between IPAP and EPAP is fixed (lowest setting is generally 4 cm of water) 7

8 Bilevel PAP Systems Similar in weight and size to CPAP units More expensive than CPAP units Louder than CPAP? Studies have not demonstrated improved adherence or efficacy compared to CPAP Reeves-Hoche et al. AJRCCM 151: , 1995 Reserved for patients who do not tolerate CPAP, especially with Difficulties with exhalation, mask leaks Chest pain as a result of lung hyperinflation CPAP Interfaces Lack of controlled trials demonstrating differences in efficacy between various CPAP interfaces Nasal interfaces Nasal masks Nasal pillows/direct nasal interfaces Full face masks Hybrid masks Oral masks 8

9 CPAP Interfaces Unique mask features Some require specific headgear Many are a cushion and frame combo Quick release clips Swivel Location of tubing connector Additional connection port for oxygen Gel-like material Nasal Pillow Interfaces ResMed Swift LT ResMed Swift FX Respironics Nuance Gel Innomed Nasal Aire II ResMed Swift FX For Her Bella 9

10 Nasal Masks ResMed AirFit N20 Respironics DreamWear ResMed Mirage Activa LT Devilbiss EasyFit ResMed AirTouch F20 ResMed Swift FX Nano Full Face Masks ResMed Quattro FX for Her DeVilbiss Quest Respironics Amara View Fisher Paykel Simplus Respironics Amara ResMed AirFit F20 10

11 Hybrid Interfaces Resmed Mirage Liberty Respironics Wisp Other Mask Interfaces Sleepweaver Fisher Paykel Oracle oral interface 11

12 CPAP Problems and Adherence Patient acceptability Patient acceptability Patient acceptability Adherence 50 60% Average nightly use 4.8 hours not so bad! Approximately 35% of patients "love" CPAP, 50% struggle with CPAP but eventually tolerate it and about 15% "hate" CPAP and never use it We are able to track CPAP use CPAP Nasal Gel Pads Gecko Nasal Pad Boomerang Gel Pad Propellaire Gel Pad 12

13 CPAP Interface Tricks CPAP Mask Fitting Program History Dentures, Eyeglasses Claustrophobia, Mouth Breathing Physical Exam Multiple trials before finding correct mask Close follow-up important CPAP Interface Tricks Large masks leak more than snug ones If in doubt, start with smaller size Dry skin can reduce mask seal Stay away from petroleum-based moisturizers Prescribe heated humidification Consider nasal steroids Clean masks with warm, soapy water No antibacterial soaps 13

14 Common Complaints with CPAP Nocturnal arousals Change mask interface Rhinitis, nasal irritation and dryness Treat with heated humidification ± nasal steroids Aerophagia Change body position or mask type Mask and mouth leaks Switch mask type/chin strap Sinusitis Add heated humidification/?oracle Common Complaints with CPAP Chest and back pain (lung hyperinflation) Consider expiratory pressure relief or bilevel device Claustrophobia Switch from a nasal mask to nasal pillows Desensitization Difficulty with exhalation Consider expiratory pressure relief or bilevel device Severe complications Case reports: epistaxis, meningitis and pneumocephalus (pituitary surgery) 14

15 How To Treat CPAP Tubing Rainout? Decrease humidification Can be difficult in winter Add heated tubing Not compatible with all PAP units Tube buddy or snugglehose to keep tubing warm to prevent condensation CPAP Tubing Insulators or, what is a SnuggleHose? Fabric tubing covers for CPAP hoses Decrease condensation from humidifiers Available in lengths up to 10 feet SnuggleHose, Tube Buddy, Tubing Wrap, Tender Tubing 15

16 PAP Follow-Up Program Data suggests that supportive intervention after initiating CPAP improves usage CBT prior to initiation with continuation after the start of therapy leads to largest increases in average machine usage Short-term educational intervention not uniformly beneficial Smith I, et al. Cochrane Database Syst Rev PAP Follow-Up Program Effective support requires additional resources to complement physician encounters For instance: MA or RT for mask fittings, downloads and ongoing education Can be hired or can team-up with DME companies who provide the service to majority of your patients Nurse practitioner or registered nurse Complement RT from DME company for mask fitting Can be trained in CBT for insomnia as well as CPAP 16

17 Optimization of Delivery of Positive Airway Pressure: Summary Start with CPAP plus heated humidification Change the interface if problems with adherence Mask fitting program If patients are unable to tolerate CPAP consider C- Flex, auto-cpap, bilevel PAP Especially if difficulty exhaling or pressure-related side effects Address nasal complaints Nasal steroids and consider nasal surgery if nasal obstruction remains problematic Supportive intervention/monitor adherence Early and often CPAP Adherence Tracking: How to Use the Data 17

18 CPAP Adherence Patterns Weaver TE et al, Sleep % consistent users Mean use 6.21 ± 1.21 hrs 47% intermittent users Mean use 3.45 ± 1.94 hrs Longitudinal Patterns of PAP Adherence Babbin et al, Multivariate Behav Res

19 Relationship Between Nightly Hours of CPAP Use and Normalization of Outcomes Why We Care About CPAP Adherence ESS FOSQ MSLT Weaver et al. Sleep 2007;30: 711 CPAP Adherence Tracking Systems CPAP adherence tracking systems are used by nearly all sleep physicians who take care of patients with OSA Requirement for Medicare CPAP coverage While CPAP adherence tracking systems have not been extensively tested, their use intuitively make sense Possible that CPAP adherence monitoring is a nice supplement to clinical decision making but does not fundamentally change results Conflicting data regarding whether use of these tracking systems by patients/providers increases adherence Algorithms for mask leak and residual AHI have not been well validated 19

20 CPAP Adherence Tracking Systems How do they work? Well, they are all different Typically track adherence, leak and efficacy Are the data reliable or reproducible? for adherence but not robust for leak or efficacy What are the best CPAP tracking systems? Good question??? Are there guidelines on how to use these systems? An Official American Thoracic Society Clinical Statement: CPAP Adherence Tracking Systems: the Optimal Monitoring Strategies and Outcome Measures (Schwab et al, AJRCCM 188, , 2013) An Official American Thoracic Society Clinical Statement: CPAP Adherence Tracking Systems: the Optimal Monitoring Strategies and Outcome Measures Richard J. Schwab, Safwan M. Badr, Lawrence J. Epstein, Peter C. Gay, David Gozal, Malcolm Kohler, Patrick Lévy, Atul Malhotra, Barbara A. Phillips, Ilene M. Rosen, Kingman P. Strohl, Patrick J. Strollo, Edward M. Weaver, Terri E. Weaver American Journal of Respiratory and Critical Care Medicine (AJRCCM): 188, ,

21 CPAP Adherence Tracking Systems How do they work? Well, they are all different Typically track adherence, leak and efficacy Are the data reliable or reproducible? for adherence but not robust for leak or efficacy What are the best CPAP tracking systems? Good question??? Are there guidelines on how to use these systems? An Official American Thoracic Society Clinical Statement: CPAP Adherence Tracking Systems: the Optimal Monitoring Strategies and Outcome Measures (Schwab et al, AJRCCM 188, , 2013) CPAP Adherence Tracking Systems Philips Respironics and ResMed have been leaders in developing CPAP tracking systems Fisher & Paykel, DeVilbiss, other manufacturers also have adherence tracking Date range of device usage Total number of nights PAP was used, not used Percentage of nights with PAP usage Percentage of nights with PAP usage 4 h/night, <4 h/night Average usage on nights when PAP was used Average usage on all nights Additional potential data Measures of heart rate, oxygen saturation High definition flow signals 21

22 Objective Tracking of CPAP Adherence is Important! Patient self-report of hours of use Low correlation with actual hours of use Routine overestimate of actual usage Hour meter on the CPAP device Meter hours/number of days Major limitation: does not provide true pattern of use Cannot detect if the mask was applied just whether the machine is on or off ResMed AirView 22

23 Respironics EncoreAnywhere Respironics EncoreAnywhere 23

24 RED < 4 hours Green > 4 hours Black - no breathing detected Hours/blower hours RED < 4 hours Green > 4 hours Black - no breathing detected Philips Respironics What would you do with this report if it were faxed to you in black and white? 24

25 Problems Tracking CPAP Adherence Patients may fail to insert smart card into CPAP unit They may have a faulty or corrupted card Some machines track CPAP use only for limited periods Confusion if data downloaded for a period that exceeds storage capacity of recording system Card may be unable to provide individualized information if PAP device or card has been used by multiple patients Flow sensor can malfunction, resulting in erroneous adherence Should time with a large leak be counted as time at effective pressure? Residual AHI and Event Detection What level of residual AHI matters? How reliable or accurate is residual AHI? 25

26 Event Detection from PAP Device v. PSG No accepted definition for appropriate cutoff for residual AHI (?AHI <5 events/hour); long term effects of residual AHI not known; AHI is the wrong terminology These devices all have different algorithms to determine apneas and hypopneas Apnea more robust than hypopnea? Mouth leak may be a problem Hypopnea on lab PSG is determined with EEG arousal or oxyhemoglobin desaturation Devices rely only on flow patterns (pneumotach) to estimate residual AHI Averaged data over many nights/months examine data during past week CPAP Unit Respiratory Event Detection: Can We Trust Residual AHI? Emerging data Devices seem to over-estimate PSG AHI at lower levels, underestimate PSG AHI at higher levels Apneas appear more reliable than hypopneas Device AHI <10 events/hour suggests good treatment efficacy Consider that AHI may be underestimated because CPAP session time rather than sleep time is the denominator Also remember that data is averaged Examining recent night to night data can provide insight All auto-paps are not created equal Terminology for residual AHI assessment should be standardized, could be reported as residual AHI Flow 26

27 What Metric of Mask Leak Should Be Used? Leak Measures Respironics Average max leak Average 90% percentile leak Average large leak (time) Average % night in large leak ResMed Average median leak (L/min) Avg 95% percentile leak Average maximum leak Most units measure liters/minute but the leak can also be reported as liters/second 27

28 Mask Leaks Data Management software displays Total Leak (either l/min or l/sec) Total Leak = Intentional Leak + Unintentional Leak Unintentional Leak = Total Leak minus Intentional Leak Intentional Leak can be estimated from the pressure/flow curves related to a given exhalation valve for specific CPAP levels May not be able to detect if the leak occurs when the mask is not applied while machine is running! (i.e. going to the bathroom during the night) Leak depends on mask and pressure 28

29 Mask Leaks - Respironics Units Respironics units: intentional leak is subtracted from the total flow for leak estimation Large leak is defined as a high leak condition where the leak levels exceeds a pre set flow vs. pressure curve (the averaged leak through all mask exhalation ports at various pressures) The device can typically tolerate about 2X times the nominal exhalation leak So if intentional leak were 20 l/m, a leak less than 50 l/m would not be registered as a large leak > 1 hour leak a problem? Mask Leaks - ResMed Units ResMed units reported leak = unintentional leak (device flow intentional leak) + mouth leak ResMed (look at 95 th percentile) < 24 liters/minute nasal interface is ok < 36 liters/minute full face interface is ok Threshold of 24 L/min as "acceptable" unintentional leak relatively arbitrary Driven by empirical experience on noise 95 th percentile used instead of median as it gives a better approximation of periods of high leak This is leak level that was not surpassed for 95% of night 29

30 Quantifying Mask Leak What is a clinically significant mask leak? Respironics: large leak for > 1 hour? ResMed: > 24 liters/minute (95 th percentile); > 36 L/minute for a full face mask (95 th percentile) DeVilbiss unit a mask leak of > 95 liters/minute Fisher & Paykel a mask leak > 60 liters/minute There may be no leak threshold that is clinically meaningful, as even a small leak directed into a patient s eyes can be problematic Averaged data over weeks/months May be due to leak around mask or through mouth (with a nasal mask) CPAP Adherence Data Tracking Transmission and Review Systems 30

31 Transmission of Tracking Data SD card Cellular modem Wireless (Wifi) Bluetooth QR code USB Phone Computer code entry Philips Respironics x x x x ResMed x x DeVilbiss x x x x x Fisher & Paykel x x x Human Design Medical x 3B Medical x x x x x Issues Older technology Availability Machine reading Cost Chip cards ( smart cards) Data safety and privacy Few studies examining data transmission Tracking of CPAP Adherence myair // AirView Compatible with ResMed devices Cloud-based care management software Daily upload from wireless modem Professional (airview.resmed.com) and patient (myair.resmed.com) web portals, patient device app (apple only) DreamMapper // EncoreAnywhere Compatible with Philips Respironics devices Interactive web-based application or phone app allows patients to self-monitor use Data download via Bluetooth or modem, syncs to computer or app on patient s phone Professional (encoreanywhere.com) and patient (mydreammapper.com) portals, patient app available for apple and android devices 31

32 MyAir DreamMapper Patients can track Hours of use Residual AHI Mask Fit Dynamic messaging (reminders) Within app education Patients can track Hours of use Residual AHI Total leak Set goals Barriers to Using CPAP Tracking Systems Data profiles are not standardized Data not always easily accessible Faxed reports are cumbersome Connectivity to server databases is suboptimal (particularly when using multiple homecare providers and device companies) May not interface with electronic health record Current care delivery systems may not be configured for this type of data management Can slow down patient flow in a busy practice 32

33 Medical Legal Ramifications of CPAP Tracking Systems Medical legal ramifications - motor vehicle crash For instance, commercial driver on CPAP These data could potentially be used in lawsuit CPAP use prior to a crash could be examined How much CPAP use is enough? Residual AHI what level matters? Is the physician also at risk? If patient s CPAP use not ideal, e.g. high residual AHI or large leak - why were these data not acted upon? How often should the data be checked (data available every night)? CPAP Tracking Systems - Take Home Use of CPAP adherence monitoring in real time for clinical decision making is not strongly supported by the literature read ATS clinical statement However, data are growing and technology is evolving quickly Current clinical care systems are not configured for this technology. Increased costs/time? Questions about event detection accuracy need to be resolved Data safety and privacy issues Medical legal issues 33

34 CPAP Tracking Systems - Take Home Adherence data mostly reliable Events (residual apnea/hypopnea) data not robust but ends of the spectrum may be useful, focus on apneas What residual AI or AHI is important? Change terminology to AHI Flow Leak what level matters? Patient self-tracking of use can improve adherence Can tracking improve outcomes? Technology, not science, is driving clinical management 34