Airway Clearance Using High Frequency Chest Wall Oscillation

Royal Brompton & Harefield NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Device: High frequency chest wall oscillation

Study type: Interventional

Funder types: Other

Identifiers

NCT00817947

06/Q0404/54

Details and patient eligibility

About

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.

Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.

Enrollment: 30 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of cystic fibrosis
• 16 years of age or over
• forced expiratory volume in one second greater than or equal to 25 percent of predicted
• hospitalised patients in a stable clinical state

Exclusion criteria

• current severe haemoptysis
• rib fractures
• pregnancy
• inability to give consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Usual airway clearance technique

Active Comparator group

Description:

Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure

Treatment:

Device: High frequency chest wall oscillation

HFCWO

Other group

Description:

High frequency chest wall oscillation

Treatment:

Device: High frequency chest wall oscillation