A Proof-of-Concept, Randomised, Controlled Cross-Over Study of Palm-seal Method versus Conventional Method using Facemask Chamber with Pressurised Metered-dose-inhaler in Children aged 6 to 36 months old

Introduction: Lack of cooperation in young children posed a great challenge for the delivery of inhaled medication using a valved holding chamber (VHC) with a facemask. Leakage between the face and facemask reduced the delivered dose to the respiratory tract and negatively impacted treatment effectiveness. Objectives: To prove that palm-seal method (PSM) is the preferred method to deliver inhaled medication using a metered-dose-inhaler (MDI) and facemask VHC for parents with children aged between 6 and 36 months, and that it is associated with a higher successful seal between the facemask and the face. Methods: In a randomised crossover study with 59 patients newly started on MDI with VHC, the parents were counselled on two different methods to administer inhaled medication, i.e. PSM and CVM, spaced 1 day apart. Parents’ preferences for both methods and the ability to ensure a good seal were observed and validated by a clinician. Results: A total of 59 patients with a mean age of 15.5±6.6 months were recruited. The most common working diagnoses were viral-induced wheeze (50%) and bronchiolitis (29%). Mean duration of hospitalisation was 4.6±3.1 days. More than half (58%) of the patients have a family member who smokes. PSM method was preferred over CVM (73% vs 27%) regardless of whether it was introduced first or later (p=0.211), the patient’s gender (p=0.378) and the education level of parents (p=0.878). The reason given was that they found it easier to restrict the child’s head movement while ensuring a good seal during drug delivery using PSM when the child was not cooperative. However, PSM was not associated with a significantly higher successful good seal (93%) when compared to the CVM (90%). Within the 3-month follow-up after discharge, the majority (>60%) of the parents switched preference from CVM to PSM, citing the reason as easier to ensure a good seal. Conclusion: PSM is the preferred method to deliver inhaled medication using MDI with VHC when the child is not cooperative.