Doug Gardenhire, EdD RRT- NPS FAARC Georgia State University Atlanta, GA January 2013 Introduc)on & Background The standard Circulaire II high- efficiency aerosol drug delivery system has been shown to be an effeclve delivery system (see next slide). The Circulaire II Hybrid has been developed for use in home care. Both Circulaire devices operate on the basis of the conserver principle and ullize a reservoir to prevent drug waste during exhalalon and increase inhaled mass of drug to the palent. The standard Circulaire has a 550 ml polyethylene bag as a reservoir whereas the Circulaire II Hybrid has a 350 ml elastomeric ball as a reservoir that can be cleaned and reused in the home care seyng. One purpose of this study was to evaluate aerosol delivery with the slightly smaller reservoir used on the Hybrid. Another purpose of the study was to evaluate the aerosol delivery performance of the Circulaire II Hybrid during operalon with numerous portable air compressors representalve of the type typically used in home care. 1
Introduc)on & Background Standard Circulaire II delivers more aerosol drug in less )me than other systems Misty Max 10 vs Circulaire II [3 ml (2.5 mg) Albuterol; Air @ 8 L/min] 40 Inhaled Mass (% of Neb Charge) 35 30 25 20 15 10 5 0.750 mg 0.375 mg 0.875 mg 0.750 mg 0 0 2 4 6 8 10 12 Elapsed Time (mins) Test #2: CIRCULAIRE II, VT 500, f 15, 30% I-time Test #9: Misty Max 10; VT 500, f15, 30% I-time 3 ml 0.083% albuterol. Top line: Circulaire II. Bo\om line: Misty Max 10. M. McPeck, unpublished data. 5 ml tobramycin (TOBI ). Top 2 lines: Circulaire II. Bo\om 2 lines: Pari LC Plus. M. McPeck, unpublished data. 3 ml 0.083% albuterol. Top 4 lines: Circulaire II. Bo\om 4 lines: AeroEclipse II Breath- Actuated Nebulizer. M. McPeck, In Vitro Inhaled Aerosol Comparison of a Conserver Nebulizer (Circulaire II) vs a Breath- Actuated Nebulizer. Respir Care 2010; 55(11): 1564. Circulaire II Hybrid with elastomeric reservoir ball Circulaire II Hybrid with reusable VixOne nebulizer and removable elastomeric reservoir ball with flange for easy gripping Removable elastomeric reservoir ball may be placed upright for drainage aeer cleaning and rinsing 2
Hypotheses The Circulaire II Hybrid high- efficiency aerosol drug delivery system with 350 ml elastomeric reservoir ball will provide acceptable aerosol delivery, compared to standard devices, when operated from typical home air compressors. The Circulaire II Hybrid on each of six models of home air compressor will perform significantly be\er than the small volume nebulizers roulnely supplied with those compressors. Materials & Methods Nebulizers (n=8) Westmed Circulaire II Hybrid Salter 8900 Pari LC Plus Westmed VixOne Pari Sprint Respironics Sidestream Respironics Sidestream Plus Invacare Compressors (n=6) DeVilbiss Pulmo- Aide Salter Aire Plus Pari Vios DeVilbiss Pulmo- Aide Compact Respironics InspiraLon Elite Invacare Select Ini)al Charge in Nebulizer 0.083% albuterol (2.5 mg/3 ml) Simulated Breathing PaPern Sine wave Rate = 15 breaths/minute Tidal Volume = 500 ml I:E RaLo = 1:1 (50% I- Lme) Analysis aerosol captured on HEPA filters at airway opening at 3 and 6 minutes of treatment Lme filters washed to elute albuterol and washing solulon analyzed for albuterol by spectrophotometry All test runs were done in triplicate and then averaged 3
Results Bold, red values indicate the results for the Circulaire II Hybrid. Bold, black, shaded values indicate the results for the nebulizers supplied with the parlcular compressor. mg = milligrams of albuterol captured on HEPA filter. % = the captured albuterol as a percentage of the 2.5 mg nebulizer charge. Results Nebulizers supplied with specific compressors vs Circulaire II Hybrid On average, the Circulaire II Hybrid delivers 81% more aerosol drug with the studied compressors, than the mean of the nebulizer/compressor combos that were tested. Further, the coefficient of varialon (CV) is much Lghter (6.8%) with the Circulaire II Hybrid than with the other nebulizers (21.8%). % Change = (Circ II Hybrid Supplied Nebulizer)/Supplied Nebulizer X 100. 4
DeVilbiss PulmoAide Compressor 0.800 0.744 0.364 0.294 0.404 0.423 0.419 0.404 0.395 0.266 0.227 0.211 0.207 0.203 0.236 0.119 0.132 Pari VIOS Compressor 0.800 0.733 0.360 0.257 0.217 0.203 0.205 0.205 0.445 0.422 0.393 0.398 0.395 0.282 0.232 0.141 0.113 5
DeVilbiss PulmoAide Compact Compressor 0.800 0.725 0.380 0.264 0.258 0.213 0.202 0.208 0.507 0.431 0.399 0.395 0.368 0.254 0.226 0.129 0.113 0.800 Salter Aire Plus Compressor 0.689 0.342 0.266 0.266 0.237 0.234 0.216 0.473 0.438 0.443 0.333 0.333 0.246 0.246 0.123 0.124 6
Respironics Inspira)on Elite Compressor 0.645 0.321 0.264 0.214 0.220 0.227 0.185 0.444 0.451 0.425 0.375 0.343 0.274 0.248 0.125 0.126 Invacare Select Compressor 0.631 0.470 0.325 0.236 0.211 0.199 0.205 0.422 0.406 0.390 0.302 0.274 0.255 0.142 0.149 0.127 7
Conclusion On a representalve sample of 6 different typical home care nebulizer air compressors, the Circulaire II Hybrid delivered an average of 81% more aerosol drug in 6 minutes. The highest increase was 135%. The greater aerosol drug delivery rate of the Hybrid was sufficient to deliver a mean (±SD) of 0.695 (±0.048) mg in 6 minutes compared to a mean (±SD) of 0.385 (±0.084) mg for the other nebulizer/compressor pairings. The coefficient of varialon for the Hybrid test runs was only 6.9% compared to 21.8% for the other nebulizer/compressor pairings. These results support the hypothesis that the Circulaire II Hybrid high- efficiency aerosol drug delivery system with 350 ml elastomeric reservoir ball will allow acceptable aerosol delivery, compared to standard devices, when operated from typical home air compressors. These results support the hypothesis that the Circulaire II Hybrid, on each of six models of home air compressor, will perform significantly be\er than the small volume nebulizers roulnely supplied with those compressors. Discussion PaLents treated in the hospital with aerosol therapy typically have their nebulizer devices operated from piped- in air or oxygen at 50 psig, with calibrated medical flowmeters, thereby assuring oplmal driving pressure and flow for the device. PaLents treated at home with aerosol therapy typically use any of a large variety of portable home air compressors that, as this study has shown, have substanlal varialon in performance, and perform poorly in comparison to others, as determined by actual inhaled mass delivery assessment of 8 different nebulizers on 6 different compressors. It may be possible, based on the informalon revealed in this study, that palents treated at home with air compressors do not received the same quality of treatment as palents treated in the hospital with nebulizers operated on piped- in gas. It may be possible, based on the informalon revealed in this study, that poorly performing home air compressors are responsible for inadequate aerosol therapy at home, which may possibly account for frequent or unlmely readmission for certain respiratory palents. It seems clear, based on the results of this study, that palents treated with the Circulaire II Hybrid on home air compressors, will received the greatest inhaled mass of aerosolized medicalon. It may be possible, that palents treated at home with the Circulaire II Hybrid will not have as many hospital readmissions and may be able to substanlally increase the interval between hospital admissions. 8
Douglas S. Gardenhire, EdD RRT- NPS FAARC Governor s Teaching Fellow Director of Clinical EducaLon Byrdine F. Lewis School of Nursing and Health Professions Division of Respiratory Therapy Georgia State University P.O. Box 4019 Atlanta, GA 30302-4019 Disclosure: This study was supported by Westmed, Inc., which provided funding for obtaining HEPA filters, laboratory supplies and reagents. 9