High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Electromed, Inc.
Information provided by:
East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier:
NCT00863616
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus production and breathlessness as cardinal features. The excess mucus production often leads to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may have an impact on improving symptoms, exercise tolerance, quality of life and reduce exacerbations.

High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall delivered from a pump through a close fitting inflatable vest. This technique has been shown to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in patients with advanced COPD.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: HFCWO - SmartVest

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Administered High Frequency Chest Wall Oscillation Technique for Mucus Clearance in COPD: An Exploratory Pilot Project Using the SMARTVEST Device

Resource links provided by NLM:


Further study details as provided by East and North Hertfordshire NHS Trust:

Primary Outcome Measures:
  • Health related quality of life (St George's Respiratory Questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise tolerance (Endurance Shuttle Walk Time achieved) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFCWO
HFCWO twice a day delivered by SmartVest device at 13Hz FOR 20min x2. Duration 4 weeks in each phase with a 2week washout.
Device: HFCWO - SmartVest
SmartVest with vest administered for 20min at 11-13Hz
Other Name: SmartVest
No Intervention: Placebo/Control
Self-administered breathing exercises

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. COPD; patients defined by a history of cough, breathlessness and/ mucus/sputum production with lung function showing FEV1/FVC <70% and FEV1<80% predicted and < 20% reversibility from baseline on administration of nebulised b2-agonist (Salbutamol 5mg)
  2. Age 40-85 years
  3. Mucus hypersecretion ( > 25 ml/72 h collection)

Exclusion Criteria:

  1. Chest wall deformity (i.e., kyphoscoliosis, Rib fractures)
  2. Severe osteoporosis
  3. Haemoptysis within the last 3 months
  4. Thoracic or abdominal surgery within 3 months
  5. Respiratory failure on non-invasive ventilator therapy
  6. Tracheostomy or neck deformities
  7. Neuro-muscular dysfunction or disability (i.e., Paralysis due to cerebrovascular disease) which may make it impossible to use the device safely
  8. Congestive heart failure (decompensated)
  9. Any other mucolytic therapy
  10. Significant hiatus hernia or gastro-esophageal reflux disease
  11. Recent myocardial infarction or unstable angina
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863616

Locations
United Kingdom
East & North Herts NHS Trust
Stevenage, Herts, United Kingdom, SG1 4AB
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
Electromed, Inc.
Investigators
Principal Investigator: Indranil Chakravorty, PhD, MRCP East & North Herts NHS Trust, Stevenage, Herts, UK
  More Information

No publications provided by East and North Hertfordshire NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indranil Chakravorty/ Consultant Physician, East & North Herts NHS Trust
ClinicalTrials.gov Identifier: NCT00863616     History of Changes
Other Study ID Numbers: 06/Q0303/57
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by East and North Hertfordshire NHS Trust:
COPD
Mucus hypersecretion
HRQL
ESWT
HFCWO

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014