The Nuts and Bolts of CPAP Including CPAP Tracking

Transcription

1 The Nuts and Bolts of CPAP Including CPAP Tracking Richard J. Schwab, M.D. Professor of Medicine Division of Sleep Medicine Pulmonary, Allergy and Critical Care Division University of Pennsylvania Medical Center Philadelphia, Pennsylvania

2 The Nuts and Bolts of CPAP Including CPAP Tracking - Disclosures NIH grants - RO1/PPG (Obesity and OSA) Consultants: Apnicure Apnex

3 The Nuts and Bolts of CPAP Including CPAP Tracking CPAP Different interfaces Costs Complications Bilevel systems Auto-adjusting Positive Airway Pressure Adaptive Servo-Ventilation CPAP adherence tracking systems

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5 Philips Respironics New CPAP Units (System One) Dry box technology Risk of water reaching the electrical circuits is virtually eliminated A fully-filled water chamber can be tilted and turned upside down without leaking water into the device System one humidity control Monitors room temperature, room humidity and flow to determine what is required to maintain the patient selected humidity level; less rain out

6 ResMed New CPAP Units - S9 Series Easy to read color display panel Very quiet Reductions in both conducted and radiated noise Superior humidification with climate control Less rain out Optional ClimateLine heated tubing The ClimateLine tube maintains the temperature of the air delivered to the patient Rainout is avoided even if the temperature in the room drops during the night

7 CPAP Interfaces No controlled trials demonstrating differences in efficacy between various CPAP interfaces Nasal interfaces Nasal masks Nasal pillows/direct nasal interfaces Full face masks (over nose and mouth) Total full face masks Mouthpieces - Oracle mask

8 ResMed Mirage Swift Nasal Pillows System Light 2.5 oz. (70 grams) Headgear ensures fit

9 ResMed Swift LT Nasal Pillows Light only 2.3 oz Easy fit rotating barrel Quiet 71% quieter than Mirage Swift II - Smaller vent holes Compact mask frame is 50% smaller than Mirage Swift II

10 ResMed Swift FX Silicone and pliable One piece pillow system Rides high on the cheeks away from the ears

11 Philips Respironics Optilife CPAP Mask

12 Philips GoLife for Men and Women The first nasal pillow masks to be built around the unique features of men and women GoLife for Women has smaller headgear that sits lower on the back of the head to prevent slippage and to help provide a better fit The result is a gender-specific fit that provides tremendous stability

13 ResMed Swift FX Bella Exclusive Bella loops accommodate a wide range of hairstyles Exceptionally soft, simple, and stable Optional headgear with pink soft wraps provide extra defense against facial marks Intuitive design is easy to adjust and wear Fit range customized for women

14 Can be worn with or without headgear 7 sizes No pressure points on the face Anatomically shaped for the nostril InnoMed Technologies Nasal-Pap Freestyle

15 ResMed CPAP Masks

16 DeVilbiss FlexAire Nasal Mask Pump inflates foam-filled air cushion Forehead pad Quick release

17 Fisher & Paykel Zest Nasal Mask Easy-Clip Silicone Seal Advanced Air Diffuser

18 Philips TrueBlue Gel Nasal Mask Gel forehead support and gel cushion for maximum comfort Gel works together with outer silicone membrane to create an effective, self-adjusting seal Headgear clips for easy removing without losing adjustments Accordion-style Freeform Spring spacer between frame and cushion allows for freedom of movement

19 Philips Respironics Comfort Gel Nasal Mask Gel interface Dual layer Cushion

20 ResMed Mirage Activa Nasal Mask May be useful for patients with a beard or a mustache Inflatable chamber expands and contracts during therapy Almost floats on the face Helps prevent leaks while minimizing pressure on face

21 Conforms to the face

22 WithMed WithRep Hanji Paper Mask Made from traditional Korean hand-made paper Lighter than alternatives Forms a tight seal using adhesive tape Does not need a humidifier the Hanji cushion maintains humidity levels Vent flow rate is higher than other masks (see below)

23 Philips Respironics ComfortGel Full Full-face Mask New forehead cushion enhanced comfort and adjustability Replaceable gel cushion enhanced fit and air seal Replaceable silicone flap with integrated retaining ring helps to ensure a tight seal

24 Philips Respironics FullLife Full-Face Mask

25 ResMed Mirage Quattro and Mirage Liberty Dual-wall pillow and cushion technology Liberty good for claustrophobia Quiet venting Quattro Liberty

26 ResMed Quattro FX Full-Face Mask Light weight Can wear glasses No T-piece

27 Fisher & Paykel Forma Full Face Mask Under-the-chin design cups the chin to add stability

28 Philips Respironics FitLife Full-Face Mask Easy to remove - may be good for patients with clastrophobia

29 Fisher & Paykel Oracle 2- Oral Mask (Anderson et al, Sleep 26; , 2003) As effective as nasal CPAP No headgear needed Increased comfort? Nasal plugs Use with a heated humidifier Increased salivation Useful for claustrophobia? Useful for patients with mouth opening? Useful for sinusitis?

30 Infant CPAP

31 Sequal Sleep Comfort Care Pad ResMed Gecko Nasal Pad ResMed Zippered Tubing Wrap

32 CPAP Interface Tricks CPAP mask fitting program is beneficial History: Dentures, eyeglasses Claustrophobia, sensitive skin, mouth breathing Physical Exam: Beard/mustache Nasal bridge: flat and wide vs. narrow Size of nose Facial trauma, craniofacial abnormalities

33 CPAP Interface Tricks Nasal pillows/direct nasal interfaces may be better for claustrophobia or those with allergies to mask material. May be problematic at higher pressures For patients allergic to silicone, use masks with synthetic rubber or vinyl interface Try Activa mask for patients with a beard/mustache or if cannot wear dentures Mouth breathers: full face mask or chin strap

34 CPAP Interface Tricks Loose 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 Multiple trials before finding correct mask

35 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 Thermosmart (F&P); Climate Line Tubing (ResMed) - heating coils in tubing Tube buddies *AASM practice parameters CPAP/Bilevel. Sleep 29: , 2006

36 CPAP Advancements: Variable Expiratory Pressure C-Flex: Respironics EPR (expiratory pressure relief): ResMed Reduction in pressure in early exp. Useful in patients with difficulty with exhalation Equally effective as CPAP No long term effect on compliance No difference in cost A-Flex - auto (BiPAP)

37 Cost of CPAP ( CPAP machines range from $300 to $700 More expensive units have compliance/efficacy capability Auto-CPAP: $600 - $900 (no code for Medicare reimbursement) BiLevel systems: $ $1600 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

38 CPAP Problems and Compliance Patient acceptability Patient acceptability Patient acceptability Compliance 50-60% Average nightly use 4.8 hours - not so bad! Approximately 35% of patients "love" CPAP, 50% initially struggle with CPAP but eventually tolerate it and about 15% "hate" CPAP and never use it

39 Effect of UPPP on CPAP Tolerance UPPP surgery may make it more likely to have a mouth leak with CPAP Pts s/p UPPP developed mouth leak at 7 cm H 2 0 Leak may be more problematic in procedures with greater resection of the soft palate Increased mouth leak due to lack of soft palate seal? Patients s/p UPPP used CPAP on average 2.2 hours/night less than non-surgically treated pts. Mortimore et al. AJRCCM 154: , Han F et al. Sleep Breath 10:37-42, 2006.

40 Bilevel Positive Airway Pressure Several different commercially available bilevel systems Independent regulation of inspiratory (IPAP) and expiratory (EPAP) airway pressures Lower expiratory pressures Algorithms to adjust pressures empiric Increase EPAP or IPAP or both? Role of IPAP and EPAP in abolishing apneas needs to be studied Auto-BiPAP systems - how do they work? The pressure differential between IPAP and EPAP is fixed (lowest setting is 4 cm of water)

41 Bilevel Systems Similar in weight and size to CPAP units More expensive than CPAP units (~$1500) Louder than CPAP? Bi-Flex systems 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

42 Autoadjusting Positive Airway Pressure (APAP) Units ability to detect/respond to changes in upper airway resistance in real time. Optimal PAP varies Positional changes Sleep state dependent changes REM vs. NREM; effects of sleep deprivation Alcohol or sedative effects Effects of upper airway infections/colds Fluctuations in weight

43 Autoadjusting Positive Airway Pressure (APAP) 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: 3 to 20 cm H 2 O

44 Responses of Automatic CPAP Devices Subjected to Different Breathing Patterns Farré et al, AJRCCM, 166, , 2002 Automatic CPAP Device/Breathing Pattern Repetitive events: Apnea Hypo-A Hypo-A + snoring Hypo-B Hypo-C Hypo-D Prolonged Flow Limitation Hypo-A Hypo-A + snoring Hypo-C Hypo-C + snoring CPAP - Dependent Events Total Responses (n = 11) (response) -- (no response) D1: DeVilbis auto-adjust; D2: AutoSet portable (ResMed); D3: AutoSet T (ResMed); D4: Virtuoso LX (Respironics); D5: Good night (Mallinckrodt) D D D D D

45 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

46 APAP: 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 More expensive than conventional CPAP This is changing

47 Adaptive Servo-Ventilation (ASV) New treatment for Cheyne-Stokes respiration and central sleep apnea (patients with CHF) ASV maintains a target minute ventilation in order to minimize apnea - units made by Respironics and ResMed In ASV a background expiratory pressure is set with a selfadjusting inspiratory pressure Inspiratory pressure varies according to a pre-programmed algorithm designed to maintain a constant minute ventilation In CSR as hyperventilation occurs inspiratory pressure is reduced As apnea occurs the ASV unit is able to trigger breaths using a pre-programmed algorithm

48 Central Sleep Apnea - Cheyne-Stokes Respiratory Pattern Cheyne-Stokes pattern of breathing is characterized by alternating periods of hyperpnea and apnea in a crescendo-descrendo pattern. Typically, the duration of hyperpnea is longer than apneas

49 Adaptive Servo-Ventilation (ASV) Szollosi et al. J Sleep Res 2: , 2006

50 Effect of Adaptive Servo-Ventilation on Central Apneas in Patients with Heart Failure 14 subjects randomized to 4 different treatment nights Teschler et al. AJRCCM 164:614-9, 2001

51 Data for PAP Follow-Up Program Smith I, et al. Cochrane Database Syst Rev Data suggests that supportive intervention after initiating CPAP improves usage 17 studies met review entry criteria (1070 subjects) Support/encouragement offered on a ongoing basis led to increased CPAP usage (0.59 hours/night) CBT prior to initiation with continuation after the start of therapy to increases in CPAP usage in 2 studies Short-term educational intervention not uniformly beneficial

52 PAP Follow-Up Program The effective types of support require additional resources to compliment physician encounters. Options include: 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 Compliment with RT from DME company for mask fitting Can be trained in CBT for insomnia and CPAP

53 PAP Follow-UP: How to Utilize? CPAP set-up can be done on same day as visit with physician to review indications and goals of CPAP therapy Close initial follow up (1 to 4 weeks) with NP/RN Equipment review Mask fit Trouble shooting CPAP adherence tracking download Additional visits as needed Nursing staff makes decision re: next MD visit (6 months if stable; sooner if residual sleepiness or other medical issues, etc)

54 CPAP Adherence Tracking Systems CPAP adherence makes a difference in outcomes CPAP adherence tracking systems are virtually used by all sleep physicians who take care of patients with apnea Requirement for Medicare CPAP payment But CPAP adherence tracking systems have not been tested - intuitively make sense It is possible that CPAP adherence monitoring is a nice supplement to clinical decision making but does not fundamentally change results Nonetheless we are able to track adherence better than almost any other disease!!!

55 CPAP Adherence Tracking Systems How do they work? What do they track (adherence, leak, efficacy) - are the data reliable? What are the best CPAP tracking systems? What standards should be used? Card systems vs. internet tracking Are there any guidelines on how to use these systems? What outcomes should be measured at 12 weeks? Why 12 weeks?

56 Relationship Between Nightly Hours of CPAP Use and Normalization of Outcomes ESS FOSQ MSLT Weaver et al. Sleep 2007;30: 711

57 Devices to Track CPAP Adherence Philips Respironics and ResMed have been the leaders in developing these CPAP tracking systems but Fisher & Paykel and DeVilbiss both have new systems Smart Card technology has been the primary means of obtaining data New developments: Wireless technology may be the future SD (secure digital) cards - photocards Measures of heart rate, oxygen saturation High definition flow signals

58 Philips Respironics Encore Anywhere and Encore Data Management Web-based (modem - wired or wireless) or SD card Measures adherence, apneas, hypopnea and leak New features (advanced event detection): Periodic breathing (Cheyne-Stokes) RERA (respiratory effort related arousal) Flow limitation Vibratory snoring Clear airway apnea (central sleep apnea)

59 ResMed CPAP Tracking Systems ResTraxx System (a wireless web-based patient monitoring solution), ResScan Data Card - measures adherence, leak, AHI New developments - data tracking methods : Direct download from device to PC Removable SD card Standard wired phoneline modem Wireless "no-touch" communication

60 ResMed CPAP Tracking Systems Sleep-disordered breathing data collected by S9 device: Adherence or compliance data (up to 365 days) Mask leak data (knowing mask type you can calculate any unintented leak) AHI, AI, CAI - central apnea index Heart rate Oxygen saturation High-resolution respiratory flow data

61 DeVilbiss SmartCode Reports Standard CPAP Auto-CPAP

62 CPAP Tracking Systems - Data Collected Conventional profile Hours/hours per night/time at pressure Enhanced profile Pressure prescription Fixed mode Auto mode Residual averaged events (Apnea/Hypopnea) Apneas Hypopneas (but there is no oximeter to help determine a desaturation for a hypopnea and no EEG for an arousal) Leak - averaged over many nights

63 Objective Tracking of CPAP Adherence is Important! Patient self-report of hours of use No correlation with actual hours of use Routinely overestimate 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

64 BiLevel Compliance Data 1

65 Compliance Data 2 2 Months of data

66 Compliance Data 2 What would you recommend?

67 Event Detection from Device vs. PSG No accepted definition for an appropriate cutoff for the residual AHI (? AHI < 5 events/hour); long term effects of residual AHI not known These devices all have different algorithms to determine apneas and hypopneas Apnea more robust than hypopnea? Mouth leak may be a problem Hypopnea on PSG is determined with an EEG arousal or oxyhemoglobin desaturation These devices rely only on flow patterns (pneumotach) to estimate the apnea/hypopnea index Averaged data over many nights

68 Mask Leaks Data Management software displays Total Leak (either l/min or l/sec) Total Leak = Intentional Leak plus 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

69 Leak depends on mask and pressure

70 Quantifying Mask Leak What is a clinically significant mask leak - no data? Respironics: large leak for > 1 hour? ResMed: > 24 liters/minute (95 th percentile)? DeVilbiss unit a mask leak of > 95 liters per minute Fisher & Paykel a mask leak > 60 liters per minute There may be no leak threshold that is clinically meaningful, as even a small leak directed into a patients eyes can be problematic Averaged data May be secondary to leaking around the mask or through the mouth (with a nasal mask)

71 Transmission of Tracking Data Machine read - Not used much anymore Data card read - SD card Wireless transmission Transmitted to someone Wireless or modem Data safety and privacy issues Very few studies examining this SD Card

72 Barriers to Using CPAP Tracking Systems Data profiles are not standardized Data is not easily accessible but improving 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 are not configured for this type of data management Can slow down patient flow in a busy practice

73 CPAP Tracking Systems - Take Home Use of CPAP adherence monitoring in real time for clinical decision making is not strongly supported by the literature However, the data are limited and the technology is young and evolving quickly Current clinical care systems are not really configured for this technology Questions about event detection accuracy need to be resolved Data safety and privacy issues

74 CPAP Tracking Systems - Take Home Adherence - data robust Events (apnea/hypopnea) - data not robust but ends of the spectrum useful - focus on apneas Residual AI < 10 events/hour on treatment Leak - data not robust but ends of the spectrum helpful; prevent time with a large leak New respiratory data - unclear utility Studies need to be performed examining utility of these systems

75 CPAP Tracking Systems - Take Home Sophisticated - technology evolving Associated with increased cost/time? Intuitively seem useful - how should they be used? OSA chronic disease with consequences Adequate treatment improves outcomes No studies as of yet that show tracking adherence improves outcomes Third party payors are increasingly requiring documented use of therapy

76 The Nuts and Bolts of CPAP Including CPAP Tracking Thank you for your attention Any Questions?

77 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?

78 Mask Leaks - ResMed Units ResMed units reported leak = unintentional leak (device flow - intentional leak) + mouth leak ResMed (look at 95 th percentile): < 24 liters per minute nasal interface is ok < 36 liters per minute full face interface is ok The threshold of 24L/min as an "acceptable" unintentional leak is relatively arbitrary, albeit driven by empirical experience on noise 95 th percentile is used instead of the median as it gives a better approximation of periods of high leak. This parameter shows the leak which was not surpassed for 95% of the night