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

Cystic Fibrosis Clinical Trial

Official title:

Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685035
• Other study ID #: 0802M26441
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2008
• Last updated: August 30, 2011
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2011
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Hill-Rom

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kempainen RR, Milla C, Dunitz J, Savik K, Hazelwood A, Williams C, Rubin BK, Billings JL. Comparison of settings used for high-frequency chest-wall compression in cystic fibrosis. Respir Care. 2010 Jun;55(6):695-701. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum wet and dry weight		Produced during each airway clearance therapy session	No
Secondary	Pre vs. post therapy spirometry, lung volumes, and single-breath nitrogen washout		Prior to and following each airway clearance therapy session	No
Secondary	Rheology and in vitro cough transportability of sputum produced immediately following airway clearance therapy session		Sputum produced during the 15 minutes immediately following airway clearance therapy sessions will be analyzed	No
Secondary	Patients' perceived comfort using the different settings for the vest device		Immediately following each airway clearance therapy	No