Airway Clearance Using High Frequency Chest Wall Oscillation

January 6, 2009 updated by: Royal Brompton & Harefield NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual airway clearance technique
Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
Device: High frequency chest wall oscillation
Airway clearance using high frequency chest wall oscillation ('The Vest')
Other: HFCWO
High frequency chest wall oscillation
Device: High frequency chest wall oscillation
Airway clearance using high frequency chest wall oscillation ('The Vest')

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight of sputum expectorated
Time Frame: Twenty-four hours
Twenty-four hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second
Time Frame: One hour (before and 30 minutes after treatment)
One hour (before and 30 minutes after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2009

Last Update Submitted That Met QC Criteria

January 6, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/Q0404/54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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