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

University of Sao Paulo

Status and phase: Terminated; Phase 1

Conditions: Bronchiectasis

Treatments: Other: PEP group; Other: Flutter group; Other: control group; Other: Group Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT01209546

USP 2010-2

Details and patient eligibility

About

The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Flutter group

Active Comparator group

Description:

In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).

Treatment:

Other: Flutter group

PEP group

Active Comparator group

Description:

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.

Treatment:

Other: PEP group

control group

Placebo Comparator group

Description:

In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions

Treatment:

Other: control group

Group Sham

Sham Comparator group

Description:

Exercise with Flutter®VRP1 without the ball inside

Treatment:

Other: Group Sham