Comparison of Airway Clearance Efficacy of Two High Frequency Chest Wall Oscillation (HFCWO) Devices in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00308958
First received: March 28, 2006
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

Patients with cystic fibrosis (CF) must perform daily bronchial drainage therapy (BD) to keep their airways clear of secretions. Many different techniques are available to achieve this and there is currently no agreement as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO is used for this purpose by CF patients throughout the United States and abroad. To perform this therapy, the patient wears a vest which fits over the entire torso and is connected to an air compressor. The compressor generates oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The oscillations produced by the most commonly used device have a sinusoidal wave form (The Vest™ Airway Clearance System, Hill-Rom Inc, St Paul, MN). Previous studies indicate this form of therapy is as effective as more traditional and cumbersome forms of therapy. The design of the pulse generator has been recently modified so that the oscillations produced have a triangular wave form (Respitech Inc, MN). Studies done at the University of Minnesota found that the air flows induced in the airways can vary substantially depending on the wave form applied to the chest. At present, the impact of using a triangular wave form on mucus removal is unknown. The proposed study will compare mucous clearance using a device generating sine wave oscillations to a device generating triangular wave oscillations.

Hypothesis: Bronchial drainage using a triangular wave form of HFCWO will result in superior sputum production compared to HFCWO using a sine wave form.

Secondary Hypotheses:

Bronchial drainage using a triangular wave form of HFCWO may result in sputum with rheologic properties distinct from sputum produced while using sine wave HFCWO.

Bronchial drainage using a triangular wave form of HFCWO may result in superior post-therapy pulmonary function tests compared to pulmonary function tests obtained following therapy with sine wave HFCWO.

Subjects will perceive bronchial drainage using a triangular wave form of HFCWO as more comfortable than airway clearance using sine wave HFCWO.


Condition Intervention
Cystic Fibrosis
Device: High frequency chest wall oscillator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Airway Clearance Efficacy of Sine Wave and Triangular Wave High Frequency Chest Wall Oscillation (HFCWO) Devices in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Average sputum production, as assessed by sputum wet and dry weights, during each treatment session.

Secondary Outcome Measures:
  • Change in pulmonary function parameters (Forced Vital Capacity and Forced Expiratory Volume in 1 second and Single-breath Nitrogen Washout) before and after therapy session for each of the treatment periods.
  • Sputum rheologic properties (adhesivity, cohesivity and viscoelastic parameters) for each treatment period.

Estimated Enrollment: 15
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of CF established by sweat chloride > 60 mmol/L.
  2. Age older than 18 years.
  3. History of chronic daily sputum production.
  4. Currently on a home therapeutic regimen that includes some form of BD performed at least 2 times daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
  5. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 4 months).
  6. Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.

Exclusion Criteria:

  1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
  2. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
  3. Chronic chest pain.
  4. Participation in another clinical trial in the previous 30 days.
  5. Use of intravenous antibiotics in the 2 months preceding enrollment.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00308958

Locations
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Robert R Kempainen, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00308958     History of Changes
Other Study ID Numbers: 0510M75246
Study First Received: March 28, 2006
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
cystic fibrosis
chest physiotherapy
airway clearance
bronchiectasis

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

ClinicalTrials.gov processed this record on October 23, 2014