NCT00817947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

Enrollment Period

8 months

First QC Date

January 6, 2009

Last Update Submit

January 6, 2009

Conditions

Cystic Fibrosis

Keywords

Airway clearanceCystic fibrosisHigh frequency chest wall oscillation

Outcome Measures

Primary Outcomes (1)

  • Weight of sputum expectorated

    Twenty-four hours

Secondary Outcomes (1)

  • Forced expiratory volume in one second

    One hour (before and 30 minutes after treatment)

Study Arms (2)

Usual airway clearance technique

ACTIVE COMPARATOR

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

HFCWO

OTHER

High frequency chest wall oscillation

Device: High frequency chest wall oscillation

Interventions

High frequency chest wall oscillationDEVICE

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

HFCWOUsual airway clearance technique

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of cystic fibrosis
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Jennifer A Pryor, PhD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

January 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

GB(1)