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Airway Clearance Using High Frequency Chest Wall Oscillation

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
High frequency chest wall oscillation
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Airway clearance, Cystic fibrosis, High frequency chest wall oscillation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Usual airway clearance technique

HFCWO

Arm Description

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

High frequency chest wall oscillation

Outcomes

Primary Outcome Measures

Weight of sputum expectorated

Secondary Outcome Measures

Forced expiratory volume in one second

Full Information

First Posted
January 6, 2009
Last Updated
January 6, 2009
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00817947
Brief Title
Airway Clearance Using High Frequency Chest Wall Oscillation
Official Title
An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Airway clearance, Cystic fibrosis, High frequency chest wall oscillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual airway clearance technique
Arm Type
Active Comparator
Arm Description
Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure
Arm Title
HFCWO
Arm Type
Other
Arm Description
High frequency chest wall oscillation
Intervention Type
Device
Intervention Name(s)
High frequency chest wall oscillation
Intervention Description
Airway clearance using high frequency chest wall oscillation ('The Vest')
Primary Outcome Measure Information:
Title
Weight of sputum expectorated
Time Frame
Twenty-four hours
Secondary Outcome Measure Information:
Title
Forced expiratory volume in one second
Time Frame
One hour (before and 30 minutes after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Pryor, PhD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

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Airway Clearance Using High Frequency Chest Wall Oscillation

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