Development of an individualized and functional CPAP ventilation mask using a fully digital workflow by facial scanning and additive manufacturing for a child with craniofacial anomalies.

AIMS: Non-Invasive Ventilation (NIV) effectiveness relies on proper mask fit, which is often difficult to achieve in patients with craniofacial anomalies. Advances in Computer-Aided Design and Manufacturing (CAD/CAM) enable rapid in-house production of customized NIV masks. Despite its potential, these remain limited by manufacturing constraints. This pilot study aimed to develop a workflow for in-house production of personalized masks and evaluate its effectiveness in an exemplary patient.

METHODS

A 4.5-year-old girl with achondroplasia was referred because of a poor fit of commercially available NIV masks. A facial scan allowed the design of a personalized nasal mask using Fusion 360 software in a semi-automated workflow. The customized interface was fabricated using additive manufacturing with medically-approved soft material. Sleep studies assessed the effectiveness of commercial versus customized masks.

RESULTS

Compared to the conventional mask, the Obstructive Apnoea-Hypopnea Index (OAHI) was reduced from 22.1/h to 0.1/h. Caregiver reported a reduction in pressure marks and fewer night-time alarms. The initial version of the personalized mask caused minor forehead pressure marks, which were effectively addressed in the second iteration. Initial setup costs were <$5400 (€6500), with material costs per mask of <$15 (€16).

CONCLUSION

This study demonstrates a fully digital CAD/CAM workflow for the in-house production of customized NIV masks. The approach offers a feasible solution for patients with craniofacial anomalies, enhancing NIV efficacy, comfort, and accessibility to personalized respiratory interfaces.