High Frequency Chest Wall Oscillation and Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
Hill-Rom
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01057524
First received: January 26, 2010
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. 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 that are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of mucus and this should further enhance mucus clearance.

People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary exacerbation, should increase the frequency and duration of their airway clearance sessions owing to the increase in quantity and viscosity of purulent bronchial secretions.In the United Kingdom, and in many other countries, the availability of physiotherapists to assist with the recommended number of daily treatments is insufficient to meet patient need. If the use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance techniques, in the early morning and evening was to facilitate recovery from an exacerbation, this would indicate an important place for high frequency chest wall oscillation in the management of people with cystic fibrosis.

Hypothesis:

The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy is as effective as the addition of self treatment in facilitating recovery from an acute infective pulmonary exacerbation, as measured by improvement in lung function, specifically forced expiratory volume in one second (FEV1).


Condition Intervention Phase
Cystic Fibrosis
Device: High Frequency Chest Wall Oscillation (HFCWO)
Other: Usual airway clearance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of High Frequency Chest Wall Oscillation During an Acute Infective Pulmonary Exacerbation of Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Mean percentage change in forced expiratory volume in one second (FEV1) [ Time Frame: 7days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Wet weight of sputum expectorated [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Length of time to next course of intravenous antibiotics [ Time Frame: Within 6 monthsof completing study ] [ Designated as safety issue: Yes ]
  • Rate of change of C-reactive protein [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Airway Clearance Technique
Two self administered treatment sessions a day and two treatments a day assisted by a Physiotherapist both using the patient's usual airway clearance method.
Other: Usual airway clearance
Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure
Other Name: Airway clearance techniques (ACT's)
Experimental: High Frequency Chest Wall Oscillation (HFCWO)
Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method.
Device: High Frequency Chest Wall Oscillation (HFCWO)
Airway clearance using the high frequency chest wall oscillator device
Other Name: 'The Vest', Hill Rom Model 205

  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
  • Hospitalised patients admitted with a pulmonary infection
  • Forced expiratory volume in one second (FEV1)of 15% predicted or over
  • 16 years of age or over

Exclusion Criteria:

  • Current severe haemoptysis
  • Rib fractures or history of spontaneous rib fractures
  • pregnancy
  • Lung abscess
  • End stage disease
  • Requiring more than two assisted treatment sessions per day
  • Requiring treatment with positive pressure
  • 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: NCT01057524

Locations
United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Hill-Rom
Investigators
Principal Investigator: Margaret Hodson Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01057524     History of Changes
Other Study ID Numbers: 09/H0708/10
Study First Received: January 26, 2010
Last Updated: February 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
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 31, 2014