Pediatric Valved Holding Chamber Facemask Leakage at Clinically Relevant Application Forces

Introduction

Effective aerosol therapy in pediatric populations, particularly among children under 4 years of age, reveals unique clinical challenges. The use of pressurized metered-dose inhalers combined with valved holding chambers (VHCs) and facemasks is a widely endorsed method for delivering inhaled medications in this population, as recommended by national and international respiratory guidelines (Nationale VersorgungsLeitlinie Asthma V5.0, Global Strategy for Asthma Management and Prevention 2025). However, the efficacy of this system critically depends on the integrity of the facemask seal, which is influenced by mask design and the applied force during administration (Häselbarth J et al., Acta Paediatr. 2020; 109(3): 565–572). A poor seal resulting from mask-to-face leakage or an ill-fitting mask can substantially reduce pulmonary aerosol deposition and cause discomfort, further compromising therapeutic effectiveness (Nikander K et al. J Aerosol Med Pulm Drug Deliv. 2014; 27 Suppl1: S4–S23).

While regulatory standards for in vitro performance testing prescribe a relatively high, fixed application force of 16 N (equivalent to a weight of 1.6 kg) to ensure a tight facemask seal (US Pharmacopeia<1602>Spacers and Valved Holding Chambers Used with Inhalation Aerosols—Characterization Tests), such conditions do not reflect clinical reality. In real-world settings, caregivers generally apply significantly lower forces when holding the mask to a child’s face. Data indicate that children aged 1–4 years typically tolerate application forces closer to 4 N, which corresponds to a weight of approximately 408 g (Minh KT et al., J Aerosol Med Pulm Drug Deliv. 2014; 27 Suppl 1:S55–S62). This discrepancy raises concerns regarding the clinical significance of laboratory-based performance assessments for pediatric inhalation masks and underscores the potential for facemask leakage under practical conditions.

To address these issues, the present study aimed to compare the leakage performance of six commercially available pediatric VHC facemask systems designed for use in infants and young children. Seal integrity was evaluated across a broad range of applied forces, including both clinically relevant and regulatory-recommended levels. By aligning testing conditions more closely with real-world clinical scenarios, this study seeks to generate data that more accurately inform clinical practice as well as future pediatric face mask design.

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Eingereicht: 02. August 2025

Angenommen nach Revision: 05. November 2025

Artikel online veröffentlicht:
12. Dezember 2025