Brief Title
Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).
Official Title
Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
Brief Summary
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.
Detailed Description
Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients. In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation. One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations. Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The Effect of FLUTTER VRP1 on respiratory mucus transport
Condition
Bronchiectasis
Intervention
control group
Study Arms / Comparison Groups
Flutter group
Description: In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30
Start Date
July 2007
Completion Date
December 2010
Primary Completion Date
January 2008
Eligibility Criteria
Inclusion Criteria: - Non Cystic Fibrosis Bronchiectasis - Amount of secretion sufficient for analysis - Capable of fulfilling the experimental protocol Exclusion Criteria: - Acute pulmonary disease - Presence of any respiratory infection in the last four weeks
Gender
All
Ages
20 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Ada C. Gastaldi, doctor, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01209546
Organization ID
USP 2010-2
Responsible Party
Principal Investigator
Study Sponsor
University of Sao Paulo
Study Sponsor
Ada C. Gastaldi, doctor, Study Chair, University of Sao Paulo
Verification Date
September 2010