Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device
Brief summary
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.
Interventions
DEVICEAerosure at 15 Hz
Active Aerosure HFAO device operating at lower frequency
DEVICEAerosure at 25 Hz
Active Aerosure HFAO device operating at higher frequency
DEVICESham Aerosure
Deactivated but identical Aerosure HFAO device
Sponsors
Actegy Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of CF (established by genotype or sweat sodium \>70mmol/l or sweat chloride of \>60 mmol/l * Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics
Exclusion criteria
* Acute respiratory failure * Haemodynamic instability (including severe right heart failure with hypotension) * Current severe haemoptysis * Ineffective cough * Rib fractures * Pregnancy * Current or recent pneumothorax * Epilepsy * Current pulmonary embolism * Oesophageal varices * Recent thoracic upper gastro-intestinal tract or facial surgery * Active tuberculosis * Recent brain, eye, ear, ENT surgery * Myocardial infarction * Ascending aortic aneurysm * Acute diarrhoea * Pulmonary embolism * Angina * Severe hypertension (systolic \>200 mm Hg, diastolic \>120 mm Hg) * Confusion/dementia * Inability to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wet weight of sputum expectorated during treatment session | up to 30 minutes after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in FEV1 | immediately before and up to 30 minutes after treatment |
| Change in VC | immediately before and up to 30 minutes after treatment |
| Change in oxygen saturation | continuously from 3 minutes prior to treatment and until 3 minutes after treatment |
| Change in ventilation | 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment |
| Change in neural respiratory drive | 5 minutes prior to treatment and 30 minutes after treatment |
Countries
United Kingdom
Outcome results
None listed