Abstract
Background: Interfaces are a crucial aspect of providing consistent airway pressures during noninvasive ventilation (NIV). Ill-fitting interfaces negatively impact the effectiveness of NIV and comfort while increasing risks of developing pressure injuries. Currently available interfaces fail to adequately serve the needs with gaps in sizing and types for the broad range of age and diversity of the pediatric population. This study aims to provide open-source data on head/facial measurements as well as ideal mask sizes for the pediatric population with the highest need of more interface options.
Methods: Collect 3D imaging of children from birth through 9 years of age (12 age groupings with plan for 3-5 enrolled in each group) utilizing the Sense 2, handheld 3D surface scanner. 28 measurements of the head and face during post-processing with Materialise 3-matic software. Study was approved through the CHOP IRB. Statistical group tests of mean, median, mode, and variance will be computed to determine distinction within and across age groupings. Sample size will be too small for ANOVA post-comparison, therefore visual comparisons and graphing techniques will be used to determine the number of interfaces to cover the defined population and sizing each interface. Create generalizable mask mockups for each group using facial measurement and design assumptions.
Results: 3D surface scans were collected from 70 children. The data for each measurement associated with three interface types (nasal mask, full face mask, occlusive prongs) were compared in a graph over age and a box and whisker plot. Each measurement could be broken into 5 groups, including extremes and central quartiles. Mapping for 5 sizes per interface type corresponding to the age ranges of 0-3m, 4-11m, 1-3y, 4-6y, and 7-9y for mask styles and 0-3m, 4-6m, 7m-3y, 4-7y, and 8-9y for the prong styles (table 1 and figure 1).
Conclusions: The compilation of facial measurements and suggested interface sizing becoming widely available can assist in the development of more interfaces that correctly fit the broader pediatric population to increase the success of NIV therapy and patient comfort.
Footnotes
Commercial Relationships: NN has relationships with Drager, Respironics, Actuated Medical, Vero-Biotech. The study received funding from Pennsylvania Pediatric Device Consortium (PPDC) - both Ms. Napolitano and Ms. Silvestro are Co-I's for the PPDC
Support: Study received funding from Pennsylvania Pediatric Device Consortium.
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