Airway Clearance Using High Frequency Chest Wall Oscillation

NCT ID: NCT00817947

Last Updated: 2009-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual airway clearance technique

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

Group Type ACTIVE_COMPARATOR

High frequency chest wall oscillation

Intervention Type DEVICE

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

HFCWO

High frequency chest wall oscillation

Group Type OTHER

High frequency chest wall oscillation

Intervention Type DEVICE

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

Interventions

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High frequency chest wall oscillation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Brompton & Harefield NHS Trust

Principal Investigators

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Jennifer A Pryor, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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Royal Brompton Hospital

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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06/Q0404/54

Identifier Type: -

Identifier Source: org_study_id

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