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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308958
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Device: High frequency chest wall oscillator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
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
Study Start Date : February 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

Secondary Outcome Measures :
  1. 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.
  2. Sputum rheologic properties (adhesivity, cohesivity and viscoelastic parameters) for each treatment period.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308958

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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Robert R Kempainen, MD University of Minnesota
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Minnesota Identifier: NCT00308958    
Other Study ID Numbers: 0510M75246
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by University of Minnesota:
cystic fibrosis
chest physiotherapy
airway clearance
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases