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High Frequency Chest Wall Oscillation and Cystic Fibrosis

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01057524
Enrollment
56
Registered
2010-01-27
Start date
2010-02-28
Completion date
2012-12-31
Last updated
2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Airway clearance, Cystic fibrosis, High frequency chest wall oscillation

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).

Interventions

DEVICEHigh Frequency Chest Wall Oscillation (HFCWO)

Airway clearance using the high frequency chest wall oscillator device

OTHERUsual airway clearance

Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure

Sponsors

Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER
Hill-Rom
CollaboratorINDUSTRY
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean percentage change in forced expiratory volume in one second (FEV1)7days

Secondary

MeasureTime frame
Wet weight of sputum expectorated24 hours
Length of time to next course of intravenous antibioticsWithin 6 monthsof completing study
Rate of change of C-reactive protein7 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026