High Frequency Chest Wall Oscillation and Cystic Fibrosis

NCT ID: NCT01057524

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-12-31

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).

Conditions

Cystic Fibrosis

Keywords

Airway clearance; Cystic fibrosis; High frequency chest wall oscillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Airway Clearance Technique

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.

Group Type: ACTIVE_COMPARATOR

Usual airway clearance

Intervention Type: OTHER

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

High Frequency Chest Wall Oscillation (HFCWO)

Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method.

Group Type: EXPERIMENTAL

High Frequency Chest Wall Oscillation (HFCWO)

Intervention Type: DEVICE

Airway clearance using the high frequency chest wall oscillator device

Interventions

High Frequency Chest Wall Oscillation (HFCWO)

Airway clearance using the high frequency chest wall oscillator device

Intervention Type: DEVICE

Usual airway clearance

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

Intervention Type: OTHER

Other Intervention Names

'The Vest', Hill Rom Model 205; Airway clearance techniques (ACT's)

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Hill-Rom

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Hodson

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Royal Brompton & Harefield NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34910295 (View on PubMed)

Other Identifiers

09/H0708/10

Identifier Type: -

Identifier Source: org_study_id