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Completed

NCT Number: NCT02509637

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

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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirão Preto Medicine School, University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • asthma
  • fistula.
  • chronic obstructive pulmonary disease

Treatment and study plan

Flutter

Device

Flutter is a small device, simple, like a plastic pipe with a mouthpiece at one end and a perforated cover on the other, containing a steel ball resting in a plastic cone inside. When the patient exhales through the flutter expiratory flow causes movement of the ball, creating an oscillatory positive pressure.

Chest Compression

Other

Manual chest compression is based on the application of forces resulting from the action of respiratory muscles or physiotherapist manual action in order to increase the alveolar pressure creating a pressure gradient to promote change in pulmonary flow and volume.It consists of vigorous compression of the chest at the beginning of expiration or during expiration.

Control

Other

Impulse Oscillometric

Other

For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks.

Dyspnea scale

Other

Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.

Acceptability and tolerance

Other

patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort

Pulse oximetry

Device

During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures

Difficulty sputum

Other

Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Pulse oximetry

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

    During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures

  2. Acceptability and tolerance

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

    30 minutes after the treatment session or control, patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort (adapted EATON, 2007).

  3. Dyspnea scale:

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

    Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil. The MRC scale comprises only five items, and the patient chooses the item corresponding to as dyspnea limits their activities of daily living. The patient reports its subjective degree of dyspnea choosing a value ranging from 1 to 5, with 1 (only suffers from shortness of breath during intense exercise), 2 (suffers from shortness of breath when walking briskly or climbing a slight slope) 3 (walks slower than people of the same age because of breathlessness or has to stop for breath even when walking slowly), 4 (stops for breath after walking less than 100 m or after a few minutes) and 5 (feel so short of breath that does not go over the house, or feel short of breath when getting dressed) (KOLEVIS et al., 2008).

  4. Adhesiveness of expectorated secretion:

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

    Immediately after the separation of secretion with saliva, mucus will be evaluated for its adhesion award a note according to visual scale described by Lopez-Vidriero et al., 1973. Test samples giving the adhesive index between 1 (fully adhered) and 2 (small movement under gravity) will be classified as adhesive and between 3 (slow moving mass) and 4 (easy handling) will be classified as non-adhesive.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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