Airway Clearance Using High Frequency Chest Wall Oscillation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Device: High frequency chest wall oscillation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis |
- Weight of sputum expectorated [ Time Frame: Twenty-four hours ] [ Designated as safety issue: Yes ]
- Forced expiratory volume in one second [ Time Frame: One hour (before and 30 minutes after treatment) ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Usual airway clearance technique
Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
|
Device: High frequency chest wall oscillation
Airway clearance using high frequency chest wall oscillation ('The Vest')
|
|
HFCWO
High frequency chest wall oscillation
|
Device: High frequency chest wall oscillation
Airway clearance using high frequency chest wall oscillation ('The Vest')
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Brompton Hospital | |
| London, United Kingdom, SW3 6NP | |
| Principal Investigator: | Jennifer A Pryor, PhD | Royal Brompton & Harefield NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Dr Jennifer A Pryor, Royal Brompton & Harefield NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00817947 History of Changes |
| Other Study ID Numbers: | 06/Q0404/54 |
| Study First Received: | January 6, 2009 |
| Last Updated: | January 6, 2009 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
|
Airway clearance Cystic fibrosis High frequency chest wall oscillation |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013