Pediatric Facemask Leakage at Clinically Relevant Application Force

Introduction: Facemask leakage significantly impacts drug delivery efficiency in pediatric patients using valved holding chambers (VHCs) with pressurized metered dose inhalers. While regulatory standards recommend an application force of 16 Newton (N) for in vitro testing of face masks, clinical experiments show that 4 N is more realistic and accepted by children aged 1 to 4 years. However, applying VHC baby masks (BM) and child masks (CM) with insufficient force can significantly reduce drug delivery due to mask-face leakage. This study compared the leakage performance of six commercially available VHC facemasks for babies and children at the clinically relevant application force of 4 N to reflect real-world usage.

Methods: Using 3D scans of pediatric faces, two Louis Infant Anatomical Face Models (LIAM) were developed to assess baby masks (BM) and child masks (CM). These models accurately replicate the facial geometry and varying tissue firmness of pediatric patients. Leakage between masks and LIAM models was tested at 4 N using a specifically designed test apparatus to ensure reproducible measurements.

Results: The average leakage at 4 N, equivalent to a weight of 408 g, varied considerably between masks. VORTEX®​ (BM 2.2%, CM 2.4%), OptiChamber®​ Diamond (BM 17.4%, CM 8.4,), and L‘Espace®​ (BM 4%, CM 18.9%) demonstrated low leakage, with VORTEX®​ showing the best sealing for both masks. AeroChamber®​ Plus Flow-Vu (BM 36.3%, CM 10.6%) and RC-Chamber®​ (BM 36.1%, CM 4.4%) showed moderate leakage. Able Spacer®​ exhibited the highest leakage (BM 94.8%), with the child mask failing to seal completely, indicating potential challenges in achieving effective drug delivery.

Conclusion: Significant variations in facemask leakage (2% to 95%) were observed between VHCs at a clinically relevant application force, underscoring the importance of mask selection in pediatric therapy. Future studies should focus on optimizing mask design to minimize leakage while maintaining child-cooperation, and on developing standardized testing protocols that better reflect real-world usage conditions. VHC masks showing a tight seal at well-tolerated application pressures, such as the VORTEX®​ BM and CM, may offer more reliable drug delivery.

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Artikel online veröffentlicht:
28. Februar 2025