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Realistic Face Model Surface Improves Pediatric
in-vitro Aerosol Studies — Amirav I et al7

Background:
  • Face models have been used as a surrogate of in vivo conditions to evaluate mask dead space and “sealability” (Sy) for lower respiratory tract (“LRT”) aerosol delivery
  • Most models have a rigid surface, unlike skin, and have been criticized for being unrealistic for predicting dead space and the force required to achieve a seal
  • No previous pediatric studies have simultaneously evaluated all of the following variables: Hard versus soft-surfaced “faces”; Mask application forces; A more representative “face”; Comparison with available masks
Aim:

To compare the mask seal and LRT aerosol delivery of two available pediatric masks using soft vs hard-surfaced “faces,” an evidence-based pediatric face model and various applied forces between the mask and “face”.

Methods:

SootherMaskTM Medium size (Fig. 1) and AeroChamber Plus® mask Medium size (Fig. 1B) were compared.

Fig. 1A: Soft face with a SootherMask Fig. 1B: Hard face with an AeroChamber Plus mask
Results: Seal
  • SootherMask achieved optimal seal at 200 gm whereas the AeroChamber mask required a significantly higher applied mass (400 gm) to achieve the same Sy
Results: “LRT” Aerosol Delivery
  • Aerosol delivery to the “LRT” with the soft “face” was also significantly greater for SootherMask than AeroChamber mask with all three applied forces (p<0.02)
LRT Aerosol Delivery LRT Aerosol Delivery

Study Conclusions:
  • Using relatively pliable, more skin-like, “face” surface material significantly improves both Sy and aerosol delivery efficiency of face masks in vitro
  • The much smaller force required to achieve Sy and greater aerosol delivery to the “LRT” with SootherMask vs the AeroChamber mask is believed to be due to the very pliable, contoured design of SootherMask, as well as the 58.3% smaller dead space (41.7 mL vs 71.5 mL)

 AEROCHAMBER PLUS and AEROCHAMBER PLUS FLOW-VU are registered to Trudell Medical International.
 INSPIRACHAMBER, INSPIRAMASK and SOOTHERMASK are registered to InspiRx, Inc.
INDICATIONS FOR USE

InspiraChamber Anti-Static Valved Holding Chamber (VHC) is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The intended environments are the home, hospitals and clinics.

Cautions:
  • Do not leave InspiraChamber, SootherMask or InspiraMask unattended with children.
Notes:
  • Storage and operating range: 5°C–40°C (41°F–104°F) at 15–95% relative humidity.
  • Inspect the device for cracks, debris, or damage that will prevent proper function after each cleaning. REPLACE IMMEDIATELY if any damages are observed. Environmental conditions, storage and proper cleaning can affect device life span.
  • This medical device is for single-patient use.
  • The intended patient population for InspiraChamber with Mouthpiece is three (3) years and older who have been prescribed pMDI medications.
  • The size of the SootherMask or InspiraMask should be determined by the size of the patient’s face.
  • If medication build-up is observed in your chamber, wash the inside of the chamber with a soft cloth according to the Instructions for Use to ensure proper performance.