New PAP Interfaces and Adherence Tracking Systems

Richard J. Schwab, M.D.Richard J. Schwab, M.D.Associate Professor of MedicineAssociate Professor of Medicine

Division of Sleep MedicineDivision of Sleep MedicinePulmonary, Allergy and Critical Care DivisionPulmonary, Allergy and Critical Care DivisionUniversity of Pennsylvania Medical Center University of Pennsylvania Medical Center

Philadelphia, PennsylvaniaPhiladelphia, Pennsylvania

CPAP

• Currently, treatment of choice for patients with OSA

• Most effective noninvasive therapy for sleep apnea

• CPAP has been convincingly shown to reduce apneic episodes and daytime sleepiness while improving neuropsychiatric function in patients with obstructive sleep apnea

VIASYS HEALTHCARECPAP Units

VIASYS HEALTHCARECPAP Units

CPAP/BiPAP Units Introduction to CPAP:What to tell the Patient

• Safer than using a medication• Not a breathing machine - the patient will not die if s/he

comes off the unit • Pneumatic splint to open the airway - it is not O2

• Noise is much less than snoring - white noise• Only need to sleep with it • Consider a desensitization program

• Get used to it - watch TV with CPAP on• Take pictures of yourself

CPAP Interfaces

• No controlled trials demonstrating differences in efficacy between various CPAP interfaces

• Nasal interfaces• Nasal masks• Nasal masks/nasal pillows • Nasal pillows/Direct nasal interfaces

• Full face masks• Mouthpieces - Oracle mask

Respironics Comfort GelNasal Mask

• Gel interface• Dual layer Cushion

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

ResMed Mirage SwiftNasal Pillows System

• Light 2.5 oz. (70 grams)• Headgear ensures fit

ResMed Mirage Quattro and Mirage Liberty

• Dual-wall pillow and cushion technology

• Quiet venting

• Claimed fit range of over 90%

InnoMed TechnologiesNasal-Pap Freestyle

• Can be worn with or without headgear

• 7 sizes• No pressure points

on the face• Anatomically

shaped for the nostril

Respironics TotalFull Face Mask

Fisher & Paykel Oracle 2- Oral Mask(Anderson et al, Sleep 26; 721-726, 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?

Infant CPAP 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

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

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• Multiple trials before finding correct mask

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 – heating coils in tubing

*AASM practice parameters CPAP/Bilevel pressure. Sleep 29: 375-380, 2006.

CPAP Advancements: Variable Expiratory Pressure

• C-Flex: Respironics REMstar• EPR (Expiratory pressure relief):

ResMed S8 • Reduction in pressure in early

expiration• Useful in patients with difficulty with

exhalation• Equally effective as CPAP• No long term effect on compliance• No difference in cost

CPAP Pressure Determination

• Optimal pressure (5 - 20 cm H2O) determined with polysomnography• Abolish apneas and hypopneas• Abolish snoring and related arousals• Maintain O2 saturation > 90%• Reduction in total arousal index

• In all positions and during REM sleep

Cost of CPAP (www.CPAP.com)

• 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: $1200 - $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

CPAP Problems and Adherence

• Patient acceptance• Patient acceptance• Patient acceptance• Average nightly use only 4.8 hours especially in

patients who skip nights of treatment• 1/4 of patients refuse CPAP• 1/4 abandon therapy within 3 years• 2/4 use it as prescribed: Adherence 50 - 60%

Weaver TE et al. Sleep 20:278-283, 1997.Engleman and Wild. Sleep Med Rev 7:81-89, 2003.

Weaver TE. In Pack, Ed: Sleep Apnea 2002:523-554.

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 H20• 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 154:1759-1762, 1996.Han F et al. Sleep Breath 10:37-42, 2006.

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

Bilevel Systems

• Similar in weight and size to CPAP units• More expensive than CPAP units (~$1500)• Louder than CPAP?• Studies have not demonstrated improved

adherence or efficacy compared to CPAPReeves-Hoche et al. AJRCCM 151:443-449, 1995

• Reserved for patients who do not tolerate CPAP, especially with• Difficulties with exhalation, mask leaks• Chest pain as a result of lung hyperinflation

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

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 H2O

Responses of Automatic CPAP Devices Subjected to Different Breathing Patterns

Farré et al, AJRCCM, 166, 469-473, 2002

43884Total Responses (n = 11)

----↑↑--CPAP - Dependent Events

↑↑↑↑↑Hypo-C + snoring

----↑↑--Hypo-C

↑↑↑↑↑Hypo-A + snoring

----------Hypo-A

Prolonged Flow Limitation

----↑↑↑Hypo-D

----↑↑--Hypo-C

↑--------Hypo-B

--↑↑↑↑Hypo-A + snoring

----------Hypo-A

↑--↑↑--Apnea

Repetitive events:

D5D4D3D2D1Automatic CPAP Device/Breathing Pattern

↑ (response) -- (no response)D1: DeVilbis auto-adjust; D2: AutoSet portable (ResMed); D3: AutoSet T (ResMed); D4: Virtuoso LX (Respironics); D5: Good night (Mallinckrodt)

Comparison of CPAP with APAP

• Meta-analysis of 9 RCTS (282 patients) published between 1996 – 2003• 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; 249-253, 2004

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 recognize central apneas and hypoventilation

• More expensive than conventional CPAP• No code for medicare reimbursement

Adaptive Ventilation

• Treats central sleep apnea, mixed apnea, and periodic breathing (CSR)

• Constant end expiration pressure to reduce obstructive events ( 5 - 10 cm water)

• Minimal pressure support until drop in ventilation noted, then increases rapidly

• When breathing resumes, pressure support reduced

• Back up rate available

Adaptive Ventilation:ResMed VPAP Adapt SV

• Compared to CPAP:

• Decreased AHI

• Improved compliance at 6 months

• ASV improved LVEF

Philippe M et al. Heart 92:337-342, 2006

Tracking CPAP Adherence

• Patient self-report of hours of use• No correlation with actual hours of use• Routinely underestimate 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

Tracking CPAP Adherence Compliance Devices

• Respironics Smart Card – EncoreAnywhereTM

• Card needs to be in unit (data stored on card) all the time• ResMed

• ResTraxx - Wireless technology (internet accessible all times)

• ResScan - similar to smart card but data stored in unit so card does not need to be in the unit (periodic download)

• DeVilbiss eCompliance• Modem based

• Puritan-Bennet (Covidien)• Card data to provide patient compliance (not available yet)

Adherence Tracking Devices: Respironics Smart Card

Smart Card Respironics

Smart Card

Adherence Tracking Devices: Respironics Smart Card Adherence

Tracking: ResMed ResTraxx

ResMedResScan

Adherence Tracking Devices: ResMedResScan

Adherence Tracking Devices

• Sophisticated – this is the future (outcomes)• Associated with increased cost • Intuitively seem useful

• OSA chronic disease with consequences• Adequate treatment improves outcomes

• No studies as of yet that show tracking adherence improves outcomes

• New Medicare guidelines for CPAP will require documented use of therapy

Defining Adherence/Efficacy

• Daily use > 4 hours• AHI < 10 events/hour on treatment• Mask Leak:

• ResMed: (Look at 95th percentile)• Less than 0.24 liters per second• Depends on interface

• Respironics• Less than 50 liters per minute• Depends on mask interface• Want to minimize time spent with large leak

New PAP Interfaces and Adherence Tracking Systems: 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, BiPAP or APAP• Especially if difficulty exhaling or high pressure related

side effects• Address nasal complaints: nasal steroids and consider

nasal surgery• Monitor adherence

• Early; ??? How often

Approaches to the Delivery of Positive Airway Pressure

• CPAP• Different interfaces• Costs• Complications

• Bilevel systems• Autoadjusting Positive Airway Pressure• Adaptive Ventilation• Adherence/Efficacy Monitoring

Puritan Bennett BreezeSleepGear

Dreamfit Nasal Mask

Nasal Pillows

Respironics ComfortLite

Respironics ComfortLite2Hans Rudolph Inc (HRI) Full Face 7600 Vmask

• Soft silicone• Dishwasher safe• Optional Sensa Seal

nasal button accessory

Fisher & PaykelFull Face Mask

• Under-the-chin design cups the chin to add stability

• 3 cushion sizes included in box

• Soft foam cushion for auto-contouring

Hudson RCI Hybrid : Dual Airway Interface

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 switching to C-Flex or a bilevel device

• Claustrophobia• Switch from a nasal mask to nasal pillows• Desensitization

• Difficulty with exhalation• Consider switching to C-Flex or a bilevel device

• Severe complications• Case reports: epistaxis, meningitis and

pneumocephalus (pituitary surgery)

• CPAP patients treated with radiofrequency turbinoplasty noted to have improved adherence Powell NB et al. Laryngoscope 111:1783-1790, 2001.

• Similar outcomes reported in European literature Biermann E. Somnologie 5:59-64, 2001.

• Cross-sectional area at the inferior turbinate as measured by acoustic rhinometry greater than 0.6cm2 associated with increased tolerance Morris LG et al. Am J Rhinol 20:133-137, 2006.

Effect of Nasal Obstruction on CPAP Tolerance

Adherence Tracking Devices: ResMed ResTraxx

• Wireless transfer of data to an Internet-accessed portal• Requirements:

• ResTraxx wireless device • Microsoft Internet Explorer 5.0 or higher• Subscription to website

• Compliance• Total hours machine use

• Efficiency data • AHI, PAP data, mask leak

• Daily or historically• Minimizes reliance on patient

Adherence Tracking: ResMed ResTraxx

Adherence Tracking Devices: DeVilbiss eCompliance

• Nightly calls to eCompliance server• Server stores and analyzes data• Non-compliance prompts email to physician’s

office• New data available within 24 hours• Reports in daily, weekly or monthly formats

Adherence Tracking Devices: DeVilbiss eCompliance

Adherence Tracking Devices: SilverLining 3 Software (Covidien - PB)

• Windows-based• Works in conjunction with the GoodKnight 420

series of sleep therapy devices – CPAP, auto-CPAP, Bi-Level

• Tracks compliance, pressure, mask leak and respiratory events

• Can be used to set up devices prior to patient use• Sandman Info (available soon)

Adherence Tracking Devices: Respironics Smart Card

Adherence Tracking Devices: ResMed AutoScan Smart Card

Adherence, efficacy, adjustments in pressure without direct contact with unit

Adherence Tracking Devices: Respironics Smart Card

• Data from Respironics CPAP, BiPAP, and Auto-CPAP machines• Compliance• Total hours machine use• Efficiency data (AHI, PAP data, mask leak)

• Requirements:• Respironics Card Reader • Personal computer• Respironics Encore Pro Software

Adherence Tracking Devices: Respironics Smart Card

• Compliance and efficiency data • Durable medical equipment companies• Clinical specialists

• Can be used to expedite pressure changes• Mail Smart Card to the patient • Pressure changes once card installed

Adherence Tracking Devices: DeVilbiss eCompliance

• Modem connected to patients CPAP unit • Compliance• Total hours machine use• Efficiency data (AHI, PAP data, mask leak)

• Requirements:• Smart Track modem• Personal computer• Proprietary Internet IPS software

Respironics Smart Card