Abstract
BackgroundOscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF). Current devices are typically reusable and require daily, or often more frequent, cleaning to prevent risk of infection by acting as reservoirs of potentially pathogenic organisms. In response, a daily disposable OPEP device, the UL-OPEP, was developed to mitigate the risk of contamination and eliminate the burdensome need for cleaning devices.MethodsA convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For one month, participants replaced their current OPEP device with a novel daily disposable device. Assessment included pre- and post-intervention lung function by spirometry, as well as Lung Clearance Index. Quality of life was assessed using the Cystic Fibrosis Questionnaire – Revised, while user experience was evaluated with a post-study survey.Results31 participants completed the study: 18 males; median age 10 years, range 4–16 years. Lung function (mean difference ± SD, %FEV1 = 1.69 ± 11.93; %FVC = 0.58 ± 10.04; FEV1: FVC = 0.01 ± 0.09), LCI (mean difference ± SD, 0.08 ± 1.13), six-minute walk test, and CFQ-R were unchanged post-intervention. Participant-reported experiences of the device were predominantly positive.ConclusionsThe disposable OPEP device maintained patients’ lung function during short term use (≤ 1 month), and was the subject of positive feedback regarding functionality while reducing the risk of airway contamination associated with ineffective cleaning.RegistrationThe study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).
Highlights
Oscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF)
The purported benefits of airway clearance were first described in The Lancet in 1901 [3], while commercial devices to aid chest physiotherapy in children with CF began to appear in the 1970s [4]
This is a combination of the Neonatal and Infant Close Monitoring Growth Chart (NICM), the UK WHO 0–4 years growth chart, and the Royal College of Paediatrics and Child Health (RCPCH) UK Growth chart [2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18], and reports lung function as interpreted by the Global Lung Function Initiative 2012 predicted values [16]
Summary
Oscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF). Current devices are typically reusable and require daily, or often more frequent, cleaning to prevent risk of infection by acting as reservoirs of potentially pathogenic organisms. Microorganisms are not effectively removed from the airways [1, 2]. Positive Expiratory Pressure (PEP) therapy was developed to promote mucus clearance by splinting open collapsed airways [5] and by increasing intrathoracic pressure distal to mucus plugging through collateral ventilation via the canals of Lambert and pores of Kohn [6]. The target “therapeutic range” expiratory pressure is detailed in the literature as 10–20 cm H2O [6]
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