Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings

This study has been completed.
Sponsor:
Collaborator:
Hill-Rom
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00685035
First received: May 22, 2008
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.


Condition Intervention Phase
Cystic Fibrosis
Device: VEST Airway Clearance System, Model 205
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sputum wet and dry weight [ Time Frame: Produced during each airway clearance therapy session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre vs. post therapy spirometry, lung volumes, and single-breath nitrogen washout [ Time Frame: Prior to and following each airway clearance therapy session ] [ Designated as safety issue: No ]
  • Rheology and in vitro cough transportability of sputum produced immediately following airway clearance therapy session [ Time Frame: Sputum produced during the 15 minutes immediately following airway clearance therapy sessions will be analyzed ] [ Designated as safety issue: No ]
  • Patients' perceived comfort using the different settings for the vest device [ Time Frame: Immediately following each airway clearance therapy ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: VEST Airway Clearance System, Model 205
    Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions.
    Other Name: High frequency chest wall oscillation
    Device: VEST Airway Clearance System, Model 205
    Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session.
    Other Name: high frequency chest wall oscillation
Detailed Description:

Patients with cystic fibrosis (CF) perform daily airway clearance therapy to facilitate removal of secretions from their airways. Many different techniques are available to achieve this and there is currently no consensus as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO) is used 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 most commonly used device is The Vest™ Airway Clearance System, (Hill-Rom Inc, St Paul, MN). Adjustment of the inflation pressure and frequency of oscillations affects the volume of displaced air and flow of air measured at the mouth of the patient. Previous studies indicate this form of therapy is as effective as more traditional and cumbersome forms of therapy. However, it is unclear which inflation pressures and oscillator frequencies provide optimal airway clearance. Some studies of sine waveform HFCWO reported the largest volume of air displacement and highest air flow measured at the mouth when using a combination of high inflation pressures with either low (7 - 10 Hz) or high frequencies (18 - 20 Hz), but most CF centers in the United States use HFCWO with lower pressures combined with mid-range frequencies (10 - 14 Hz). Furthermore, there are no previous studies assessing the affect of sine waveform HFCWO settings on sputum production. As a result, there is no consensus on which pressure and frequency settings are most efficacious for CF patients.

  Eligibility

Ages Eligible for Study:   18 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 airway clearance performed with a HFCWO device at least once 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 3 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. Chest pain requiring use of narcotic for pain control.
  4. Current participation in another clinical trial.
  5. Use of intravenous antibiotics for CF respiratory complications in the 2 months preceding enrollment.
  6. No prior experience using HFCWO devices for airway clearance
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00685035

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
Hill-Rom
Investigators
Principal Investigator: Robert R Kempainen, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00685035     History of Changes
Other Study ID Numbers: 0802M26441
Study First Received: May 22, 2008
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
high frequency chest wall oscillation, cystic fibrosis

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 23, 2014