Comparative analysis of pediatric face mask sealing with valved holding chambers

Leaking face masks reduce inhalation therapy effectiveness when inhaling with valved holding chambers (VHC) and pMDIs. A tight seal, independent of caregiver pressure, improves aerosol delivery and ensures consistent treatment for young patients. This study compared the sealing characteristics of the VORTEX^® VHC with its newly developed baby mask (BM) and child mask (CM) and five commercially available VHCs combined with their respective face masks [AeroChamber^® Plus Flow-Vu (AC, Trudell), OptiChamber^® Diamond (OC, Philips Respironics), L‘Espace^® (LE, Air Liquid), Able Spacer^® (AS, Clement Clarke), and RC-Chamber^® (RC, CEGLA)]. Sealing tests were performed using age-appropriate baby and child in vitro face models and five different contact forces (4N, 6N, 8N, 12N, 16N). Additionally, we have explored the hygienic reprocessing of VORTEX® face masks to ensure safe inhalation therapy over the device's lifetime. The VORTEX^® combined with its new face masks showed the most robust sealing behavior (average seal across force range of 97.9% for BM and 98% for CM). OC (BM 93.5%, CM 95.4%) and LE (BM 98.2%, CM 94.3%) possessed slightly lower average seals whereas AC (BM 79.8%, CM 85.6%) and RC (BM 66%, CM 62.8%) showed strongly force-dependent sealing. Lowest sealing was found for AS (BM 14.3%, CM <5%). Complemental aerosol performance tests are planned. VORTEX^® masks showed excellent qualities allowing dishwasher, boiling, and autoclave (134°C) reprocessing allowing safe application in hospitals and at home. VORTEX^® face masks demonstrate superior sealing and thus reduced leakage across different contact forces compared to other commercially available VHC and thus, contribute to a better disease control.