High Frequency Chest Wall Oscillation and Cystic Fibrosis

Study Overview
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Brief Summary
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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).

Official Title
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The Use of High Frequency Chest Wall Oscillation During an Acute Infective Pulmonary Exacerbation of Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: High Frequency Chest Wall Oscillation (HFCWO)
* Other: Usual airway clearance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Airway Clearance Technique<br>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. | Other: Usual airway clearance<br>* Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure<br>* Other names: Airway clearance techniques (ACT's);|
| Experimental: High Frequency Chest Wall Oscillation (HFCWO)<br>Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method. | Device: High Frequency Chest Wall Oscillation (HFCWO)<br>* Airway clearance using the high frequency chest wall oscillator device<br>* Other names: 'The Vest', Hill Rom Model 205;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage change in forced expiratory volume in one second (FEV1) |  | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet weight of sputum expectorated |  | 24 hours | 
| Length of time to next course of intravenous antibiotics |  | Within 6 monthsof completing study | 
| Rate of change of C-reactive protein |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway clearance, Cystic fibrosis, High frequency chest wall oscillation