Clinical trial NCT02509637: Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
Official title: Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Respiratory System
Physical Therapy Modalities
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory System Impedance
timeFrame: In the primary evaluation, and after seven and fourteen days.
measure: Difficulty sputum
timeFrame: In the primary evaluation, and after seven and fourteen days.
measure: Secretions weight
timeFrame: In the primary evaluation, and after seven and fourteen days.
Secondary outcomes:
measure: Pulse oximetry
timeFrame: In the primary evaluation, and after seven and fourteen days.
measure: Acceptability and tolerance
timeFrame: In the primary evaluation, and after seven and fourteen days.
measure: Dyspnea scale:
timeFrame: In the primary evaluation, and after seven and fourteen days.
measure: Adhesiveness of expectorated secretion:
timeFrame: In the primary evaluation, and after seven and fourteen days.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto Medicine School, University of São Paulo
state: SP
Study officials:
affiliation: Ribeirão Preto Medicine School - University of São Paulo
name: Ada C Gastaldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.