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

Phase 1

Terminated

• Conditions: Bronchiectasis
• Interventions: Other: Flutter group; Other: PEP group; Other: control group; Other: Group Sham

• Registration Number: NCT01209546
• Lead Sponsor: University of Sao Paulo

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 Timeline

• Study Start: 2007-07
• Primary Completion: 2008-01
• Study First Submitted: 2010-07-12
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Study Completion: 2010-12
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Non Cystic Fibrosis Bronchiectasis
• Amount of secretion sufficient for analysis
• Capable of fulfilling the experimental protocol

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Exclusion Criteria

• Acute pulmonary disease
• Presence of any respiratory infection in the last four weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flutter group	Flutter group	In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
PEP group	PEP group	In PEP group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland) 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.
control group	control group	In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions
Group Sham	Group Sham	Exercise with Flutter®VRP1 without the ball inside

Primary Outcome Measures

Name	Time	Method
The Effect of FLUTTER VRP1 on respiratory mucus transport	five years	30 patients with bronchiectasis will receive sessions with the Flutter®VRP1 or PEP for 30 minutes daily in a randomized, crossover study. Weekly secretion samples will be collected and evaluated for mucociliary relative transport velocity(RTV), displacement in a simulated cough machine(SCM) and contact angle measurement(CAM).

Trial Locations

Locations (1)

Faculty of Medicine of Ribeirão Preto, University of Sao Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil