Laboratory Performance Evaluation of Prototype Nasal Mask for Infants Using the ADAM-III Infant Face Model: Proof-of-Concept

Jolyon Mitchell, Jason Suggett, Mark Nagel, Valentina Avvakoumova, Rubina Ali, Heather Schneider

The onset of symptoms related to a heterogeneous group of respiratory diseases termed Chronic Lung Disease of Infancy can take place from birth, and may require treatment with inhaled medication. The most suitable patient interface is a facemask for this group of patients. Dead-space within the facemask should ideally be minimized to avoid re-breathing as well as loss of medication by deposition within the facemask and on the face with this population, whose inhaled volume when tidal breathing can be ≤ 50 mL. Infant facial anatomy is very different from that of older children and it is therefore insufficient to merely rely on scaled down versions of adult masks A prototype nasal mask has been developed by Trudell Medical International to address this currently unmet need. A proof-of-concept laboratory study was undertaken delivering one actuation of pMDI-delivered salbutamol via an AeroChamber mini* aerosol chamber (AC), equipped with nasal mask that was applied to the nose of the ADAM-III infant face and nasopharyngeal airway model either with light or heavy force of 0.8 kg (7.8 N) and 1.6 kg (15.6 N) respectively. Tidal breathing was simulated (tidal volume = 50 mL; duty cycle = 25%, respiration rate = 30 cycles/min). Approximately 5 μg/actuation (ca. 5% label claim dose) was able to be delivered using either applied force, representing potential medication delivery to the carina. This level is of the same order as in previously reported clinical evaluations for pMDI-delivered medications, although to infants with significant airway obstruction.
* Trademark of Trudell Medical International and Monaghan Medical Corporation

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