High Frequency Chest Wall Oscillation and Cystic Fibrosis

NCT01057524 | Completed Phase 3 DMC

• 1 other identifier: 09/H0708/10
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean percentage change in forced expiratory volume in one second (FEV1)

  7days

Secondary Outcomes (3)

• 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

Study Arms (2)

Usual Airway Clearance Technique

ACTIVE COMPARATOR

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

High Frequency Chest Wall Oscillation (HFCWO)

EXPERIMENTAL

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)

Interventions

High Frequency Chest Wall Oscillation (HFCWO) DEVICE

Airway clearance using the high frequency chest wall oscillator device

Also known as: 'The Vest', Hill Rom Model 205

High Frequency Chest Wall Oscillation (HFCWO)

Usual airway clearance OTHER

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

Also known as: Airway clearance techniques (ACT's)

Usual Airway Clearance Technique

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis
• Hospitalised patients admitted with a pulmonary infection
• Forced expiratory volume in one second (FEV1)of 15% predicted or over
• years of age or over

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Hill-Rom: collaborator

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34910295 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Margaret Hodson

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 11, 2016

Record last verified: 2012-02

Locations

GB (1)