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Completed

NCT Number: NCT01057524

High Frequency Chest Wall Oscillation and Cystic Fibrosis

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).

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Frequency Chest Wall Oscillation (HFCWO)

Device

Airway clearance using the high frequency chest wall oscillator device

Other names: 'The Vest', Hill Rom Model 205

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

Other names: Airway clearance techniques (ACT's)

Primary outcomes

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

    Time frame: 7days

Secondary outcomes

  1. Wet weight of sputum expectorated

    Time frame: 24 hours

  2. Length of time to next course of intravenous antibiotics

    Time frame: Within 6 monthsof completing study

  3. Rate of change of C-reactive protein

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Hill-Rom
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2010
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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