High Frequency Chest Wall Oscillation and Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
High Frequency Chest Wall Oscillation (HFCWO)
Usual airway clearance
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
- Hospitalised patients admitted with a pulmonary infection
- Forced expiratory volume in one second (FEV1)of 15% predicted or over
- 16 years of age or over
Exclusion Criteria:
- Current severe haemoptysis
- Rib fractures or history of spontaneous rib fractures
- pregnancy
- Lung abscess
- End stage disease
- Requiring more than two assisted treatment sessions per day
- Requiring treatment with positive pressure
- Inability to give consent
Sites / Locations
- Royal Brompton & Harefield NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Airway Clearance Technique
High Frequency Chest Wall Oscillation (HFCWO)
Arm Description
Two self administered treatment sessions a day and two treatments a day assisted by a Physiotherapist both using the patient's usual airway clearance method.
Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method.
Outcomes
Primary Outcome Measures
Mean percentage change in forced expiratory volume in one second (FEV1)
Secondary Outcome Measures
Wet weight of sputum expectorated
Length of time to next course of intravenous antibiotics
Rate of change of C-reactive protein
Full Information
NCT ID
NCT01057524
First Posted
January 26, 2010
Last Updated
November 10, 2016
Sponsor
Imperial College London
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, Hill-Rom
1. Study Identification
Unique Protocol Identification Number
NCT01057524
Brief Title
High Frequency Chest Wall Oscillation and Cystic Fibrosis
Official Title
The Use of High Frequency Chest Wall Oscillation During an Acute Infective Pulmonary Exacerbation of Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, Hill-Rom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. 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 that are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of mucus and this should further enhance mucus clearance.
People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary exacerbation, should increase the frequency and duration of their airway clearance sessions owing to the increase in quantity and viscosity of purulent bronchial secretions.In the United Kingdom, and in many other countries, the availability of physiotherapists to assist with the recommended number of daily treatments is insufficient to meet patient need. If the use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance techniques, in the early morning and evening was to facilitate recovery from an exacerbation, this would indicate an important place for high frequency chest wall oscillation in the management of people with cystic fibrosis.
Hypothesis:
The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy is as effective as the addition of self treatment in facilitating recovery from an acute infective pulmonary exacerbation, as measured by improvement in lung function, specifically forced expiratory volume in one second (FEV1).
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Airway Clearance Technique
Arm Type
Active Comparator
Arm Description
Two self administered treatment sessions a day and two treatments a day assisted by a Physiotherapist both using the patient's usual airway clearance method.
Arm Title
High Frequency Chest Wall Oscillation (HFCWO)
Arm Type
Experimental
Arm Description
Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method.
Intervention Type
Device
Intervention Name(s)
High Frequency Chest Wall Oscillation (HFCWO)
Other Intervention Name(s)
'The Vest', Hill Rom Model 205
Intervention Description
Airway clearance using the high frequency chest wall oscillator device
Intervention Type
Other
Intervention Name(s)
Usual airway clearance
Other Intervention Name(s)
Airway clearance techniques (ACT's)
Intervention Description
Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure
Primary Outcome Measure Information:
Title
Mean percentage change in forced expiratory volume in one second (FEV1)
Time Frame
7days
Secondary Outcome Measure Information:
Title
Wet weight of sputum expectorated
Time Frame
24 hours
Title
Length of time to next course of intravenous antibiotics
Time Frame
Within 6 monthsof completing study
Title
Rate of change of C-reactive protein
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cystic fibrosis
Hospitalised patients admitted with a pulmonary infection
Forced expiratory volume in one second (FEV1)of 15% predicted or over
16 years of age or over
Exclusion Criteria:
Current severe haemoptysis
Rib fractures or history of spontaneous rib fractures
pregnancy
Lung abscess
End stage disease
Requiring more than two assisted treatment sessions per day
Requiring treatment with positive pressure
Inability to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Hodson
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton & Harefield NHS Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34910295
Citation
Burnham P, Stanford G, Stewart R. Autogenic drainage for airway clearance in cystic fibrosis. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD009595. doi: 10.1002/14651858.CD009595.pub3.
Results Reference
derived
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High Frequency Chest Wall Oscillation and Cystic Fibrosis
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