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Clinical Trials/NCT02509637
NCT02509637CompletedNot Applicable

Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients

University of Sao Paulo2 sites in 1 country40 target enrollmentStarted: August 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Difficulty sputum

Study Overview

Brief Summary

Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. The aim of this study is to evaluate the impedance of the respiratory system, by impulse oscillometry, after breathing exercises with chest compression or flutter in patients with bronchiectasis, considering that there are no results in the literature on the effect of these techniques in the small airways of these patients.

Detailed Description

Bronchiectasis patients and healthy subjects will be evaluated before and after a 30 minutes session of control, breathing exercises with flutter valve, that is a device that produces oscillation and positive pressure during the expiratory phase, or chest compression, that is a manual manoeuvre in the right and left sides of the lower chest, all of them in a sitting position. The main outcome will be obtained by impulse oscillometry, that is a method to access large and small airways, to evaluate the resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres) of respiratory system for the whole breath and for inspiratory and expiratory phase. Additionally, will be analysed the dyspnea using the Medical Research Council scale; acceptability and tolerability scale; pulse oxymetry; difficulty of expectoration score; and volume, adhesivity and purulence of sputum.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
30 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • aged between 30 and 80 years
  • diagnosed with bronchiectasis not resulting from cystic fibrosis, defined by history and full clinical examination and confirmed by computed tomography.

Exclusion Criteria

  • Chest pain
  • acute hemoptysis
  • recent history rib fracture and pneumothorax
  • respiratory infection in the last 4 weeks prior to study
  • cystic fibrosis
  • chronic obstructive pulmonary disease

Outcomes

Primary Outcomes

Difficulty sputum

Time Frame: In the primary evaluation, and after seven and fourteen days.

Patients inform the ease or difficulty in expectoration in accordance with a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult. (Burioka, 1998). The scale will be applied at baseline and always after the intervention to assess whether there is difference in the difficulty of sputum between sessions.

Respiratory System Impedance

Time Frame: In the primary evaluation, and after seven and fourteen days.

Will be evaluated the resistance (R), reactance (X), reactance area (AX) and resonance frequency (Fres) before, immediately after the intervention and after 30 minutes of rest in order of identifying changes in the components of resistance of airways of individuals.

Secretions weight

Time Frame: In the primary evaluation, and after seven and fourteen days.

The secretions are collected in the universal and heavy collectors on a precision balance.They will be evaluated in the total weight measurements and a dry weight and wet mucus. The weight of mucus of each interventions are compared to determine a technique with improved efficiency for removal of secretions.

Secondary Outcomes

  • Adhesiveness of expectorated secretion:(In the primary evaluation, and after seven and fourteen days.)
  • Acceptability and tolerance(In the primary evaluation, and after seven and fourteen days.)
  • Pulse oximetry(In the primary evaluation, and after seven and fourteen days.)
  • Dyspnea scale:(In the primary evaluation, and after seven and fourteen days.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ada Clarice Gastaldi

PhD

University of Sao Paulo

Study Sites (2)

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