This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
Active Aerosure HFAO device operating at lower frequency
Active Aerosure HFAO device operating at higher frequency
Deactivated but identical Aerosure HFAO device
King's College Hospital, Bessemer Road, Denmark Hill
London, United Kingdom
Wet weight of sputum expectorated during treatment session
Time frame: up to 30 minutes after treatment
Change in FEV1
Time frame: immediately before and up to 30 minutes after treatment
Change in VC
Time frame: immediately before and up to 30 minutes after treatment
Change in oxygen saturation
Time frame: continuously from 3 minutes prior to treatment and until 3 minutes after treatment
Change in ventilation
Time frame: 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
Change in neural respiratory drive
Time frame: 5 minutes prior to treatment and 30 minutes after treatment
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