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Background: The aim of this study was to evaluate the effect of a newly designed foam cushion on the air leakage and pressure when applied to the face. Methods: A teaching manikin connected to a bilevel positive airway pressure ventilator attached to four different brands of oronasal masks (Amara, Mirage, Forma, and Wizard) was used. The foam cushions of 5-mm and 10-mm-thickness were attached to the masks, and each mask was tested without a cushion. Six pressure sensors were placed on the manikin's face, and data were recorded. Inspiratory volume and air leak flow from the ventilator were observed. Results: Air leakage was influenced by both the mask brand and the presence of a cushion. The presence of a cushion did not affect the Wizard mask in terms of leakage ( p = 0.317) or inspiratory volume ( p = 0.726). The Wizard and Amara masks generated the lowest contact pressure on the frontal forehead ( p &lt; 0.001) compared to the other five points. Conclusions: Utilisation of a cushion reduces air leakage and maintains greater inspiratory volume regardless of its thickness. The contact pressure varies depending on the brand of the mask, which would require a difference in the thickness of the cushion for pressure reduction.

In Vitro Evaluation of Facial Pressure and Air Leak with a Newly Designed Cushion for Non-Invasive Ventilation Masks