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Completed

NCT Number: NCT00817947

Airway Clearance Using High Frequency Chest Wall Oscillation

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. 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 which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.

Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.

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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 Hospital

London, SW3 6NP, 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
  • 16 years of age or over
  • forced expiratory volume in one second greater than or equal to 25 percent of predicted
  • hospitalised patients in a stable clinical state

Exclusion criteria

  • current severe haemoptysis
  • rib fractures
  • pregnancy
  • inability to give consent

Treatment and study plan

High Frequency Chest Wall Oscillation

Device

Airway clearance using high frequency chest wall oscillation ('The Vest')

Primary outcomes

  1. Weight of sputum expectorated

    Time frame: Twenty-four hours

Secondary outcomes

  1. Forced expiratory volume in one second

    Time frame: One hour (before and 30 minutes after treatment)

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 7, 2009
Registry last updated
Jan 7, 2009

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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