An evaluation of a novel disposable Oscillating Positive Expiratory Pressure (OPEP) device in children with Cystic Fibrosis

Abstract

Methods: A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For a period of one month, participants replaced their current OPEP device (used daily for up to 6 months) with the SoloPep device (daily disposable). Lung function was assessed immediately before and after adopting the new device using Spirometry. Lung Clearance Index (LCI) was assessed via multiple-breath nitrogen washout. User experience of SoloPep was evaluated with a post-study questionnaire, rated on five-point Likert scales. All participants were trained at the first clinic visit to use the SoloPep device. This was performed using a proprietary software program. Results: 31 participants completed the study: 13 females; median age 10 years, range 4-16 years. Lung function (%FEV1, mean ± SD; baseline = 83.26 ± 19.63, follow-up = 86.31 ± 20.95) and LCI (mean ± SD; baseline = 10.05 ± 2.86, follow-up = 9.66 ± 2.10) were unchanged post-intervention. The majority of participants believed that SoloPep was easy to use (72% Strongly Agree; 24% Agree; 4% Neutral), dealt with issues they had with cleaning of their current OPEP device (72% Strongly Agree; 16% Agree; 12% Neutral), and encouraged them to perform OPEP therapy more regularly (52% Strongly Agree; 28% Agree; 16% Neutral, 4% Strongly Disagree). All agreed that they would adopt SoloPep as their usual OPEP device (76% Strongly Agree; 24% Agree). No adverse device-related events were reported during SoloPep use. Conclusion: SoloPep demonstrated equivalence to existing OPEP devices in this cohort and may be a useful adjunct to aid airway clearance, reducing risk of cross-contamination.