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

NCT02509637 | Completed DMC

• 1 other identifier: USP 2015-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Respiratory System; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (3)

• Respiratory System Impedance

  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.

  In the primary evaluation, and after seven and fourteen days.

• Difficulty sputum

  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.

  In the primary evaluation, and after seven and fourteen days.

• Secretions weight

  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.

  In the primary evaluation, and after seven and fourteen days.

Secondary Outcomes (4)

• Pulse oximetry

  In the primary evaluation, and after seven and fourteen days.

• Acceptability and tolerance

  In the primary evaluation, and after seven and fourteen days.

• Dyspnea scale:

  In the primary evaluation, and after seven and fourteen days.

• Adhesiveness of expectorated secretion:

  In the primary evaluation, and after seven and fourteen days.

Study Arms (3)

Flutter Intervention

ACTIVE COMPARATOR

After initial evaluation, the subjects will perform breathing exercises with quiet inspiration and prolonged expiration on the device for thirty minutes, with breaks of one minute every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence.

Device: Flutter; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum

Chest Compression Intervention

ACTIVE COMPARATOR

After initial evaluation, the subjects will be instructed to perform deep breaths between three quiet inspiration brought, and expiration will be accompanied by bilateral compression with the therapist's hands on the lower ribs during thirty minutes with one minute intervals of rest every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence.

Other: Chest Compression; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum

Crontrol Intervention

ACTIVE COMPARATOR

After initial evaluation, patients will be remain seated quiet breathing without any guidance for thirty minutes. Immediately after this time will be held reassessment with Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied to acceptance and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for wight, adhesiveness and purulence.

Other: Control; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum

Interventions

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.

Flutter Intervention

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.

Chest Compression Intervention

Control OTHER

Crontrol Intervention

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.

Chest Compression Intervention; Crontrol Intervention; Flutter Intervention

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.

Chest Compression Intervention; Crontrol Intervention; Flutter Intervention

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

Chest Compression Intervention; Crontrol Intervention; Flutter Intervention

Pulse oximetry DEVICE

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

Chest Compression Intervention; Crontrol Intervention; Flutter Intervention

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.

Chest Compression Intervention; Crontrol Intervention; Flutter Intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Ribeirão Preto Medicine School, University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (6)

• Tambascio J, de Souza LT, Lisboa RM, Passarelli Rde C, de Souza HC, Gastaldi AC. The influence of Flutter(R)VRP1 components on mucus transport of patients with bronchiectasis. Respir Med. 2011 Sep;105(9):1316-21. doi: 10.1016/j.rmed.2011.04.017.

  PMID: 21641196 BACKGROUND

• Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.

  PMID: 14680096 BACKGROUND

• Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.

  PMID: 19648517 BACKGROUND

• McCarren B, Alison JA, Herbert RD. Manual vibration increases expiratory flow rate via increased intrapleural pressure in healthy adults: an experimental study. Aust J Physiother. 2006;52(4):267-71. doi: 10.1016/s0004-9514(06)70006-x.

  PMID: 17132121 BACKGROUND

• Eaton T, Young P, Zeng I, Kolbe J. A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2007;4(1):23-30. doi: 10.1177/1479972306074481.

  PMID: 17416150 RESULT

• de Souza Simoni LH, Dos Santos DO, de Souza HCD, Baddini-Martinez JA, Santos MK, Gastaldi AC. Acute Effects of Oscillatory PEP and Thoracic Compression on Secretion Removal and Impedance of the Respiratory System in Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2019 Jul;64(7):818-827. doi: 10.4187/respcare.06025. Epub 2019 May 28.

  PMID: 31138732 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Chest Wall Oscillation; Drug Tolerance; Oximetry

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Ada C Gastaldi, PhD

  Ribeirão Preto Medicine School - University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 28, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

BR (1)