Airway Clearance Using High Frequency Chest Wall Oscillation

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00817947
First received: January 6, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Device: High frequency chest wall oscillation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Weight of sputum expectorated [ Time Frame: Twenty-four hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Forced expiratory volume in one second [ Time Frame: One hour (before and 30 minutes after treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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')
HFCWO
High frequency chest wall oscillation
Device: High frequency chest wall oscillation
Airway clearance using high frequency chest wall oscillation ('The Vest')

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817947

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Jennifer A Pryor, PhD Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Jennifer A Pryor, Royal Brompton & Harefield NHS Trust
ClinicalTrials.gov Identifier: NCT00817947     History of Changes
Other Study ID Numbers: 06/Q0404/54
Study First Received: January 6, 2009
Last Updated: January 6, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Airway clearance
Cystic fibrosis
High frequency chest wall oscillation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014