NCT01209546

Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).

Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
OTHER	control group	In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
OTHER	Flutter group	Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP).
OTHER	PEP group	Patients have done exercise sessions with Flutter® VRP1 without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (Flutter®VRP1).
OTHER	Group Sham	Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes without the ball inside daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP)

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-01-01
• Completion: 2010-12-01
• First posted: 2010-09-27
• Last updated: 2012-06-28

Locations

1 site across 1 country: Brazil