Airway Clearance Using High Frequency Chest Wall Oscillation

Phase 3

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: High frequency chest wall oscillation

• Registration Number: NCT00817947
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-01
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Last Update Submitted: 2009-01-06
• Study First Posted: 2009-01-07
• Last Update Posted: 2009-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual airway clearance technique	High frequency chest wall oscillation	Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
HFCWO	High frequency chest wall oscillation	High frequency chest wall oscillation

Primary Outcome Measures

Name	Time	Method
Weight of sputum expectorated	Twenty-four hours

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second	One hour (before and 30 minutes after treatment)

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom