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

Sponsored by:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00308958

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

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by University of Minnesota:

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
Estimated Study Completion Date:	August 2006

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of CF established by sweat chloride > 60 mmol/L.
Age older than 18 years.
History of chronic daily sputum production.
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.
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).
Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.

Exclusion Criteria:

Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
Chronic chest pain.
Participation in another clinical trial in the previous 30 days.
Use of intravenous antibiotics in the 2 months preceding enrollment.

Contacts and Locations

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

Investigators

Principal Investigator:

Robert R Kempainen, MD

University of Minnesota

More Information

Publications indexed to this study:

Kempainen RR, Williams CB, Hazelwood A, Rubin BK, Milla CE. Comparison of high-frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis. Chest. 2007 Oct;132(4):1227-32. Epub 2007 Sep 21.

Study ID Numbers:	0510M75246
Study First Received:	March 28, 2006
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00308958
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

cystic fibrosis
chest physiotherapy
airway clearance
bronchiectasis

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Bronchiectasis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009