Airway Clearance Using High Frequency Chest Wall Oscillation
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
High frequency chest wall oscillation
Sponsored by

About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Airway clearance, Cystic fibrosis, High frequency chest wall oscillation
Eligibility Criteria
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
Sites / Locations
- Royal Brompton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Usual airway clearance technique
HFCWO
Arm Description
Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
High frequency chest wall oscillation
Outcomes
Primary Outcome Measures
Weight of sputum expectorated
Secondary Outcome Measures
Forced expiratory volume in one second
Full Information
NCT ID
NCT00817947
First Posted
January 6, 2009
Last Updated
January 6, 2009
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00817947
Brief Title
Airway Clearance Using High Frequency Chest Wall Oscillation
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Airway clearance, Cystic fibrosis, High frequency chest wall oscillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual airway clearance technique
Arm Type
Active Comparator
Arm Description
Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
Arm Title
HFCWO
Arm Type
Other
Arm Description
High frequency chest wall oscillation
Intervention Type
Device
Intervention Name(s)
High frequency chest wall oscillation
Intervention Description
Airway clearance using high frequency chest wall oscillation ('The Vest')
Primary Outcome Measure Information:
Title
Weight of sputum expectorated
Time Frame
Twenty-four hours
Secondary Outcome Measure Information:
Title
Forced expiratory volume in one second
Time Frame
One hour (before and 30 minutes after treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Pryor, PhD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
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Airway Clearance Using High Frequency Chest Wall Oscillation
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