Clinical Trial: Lung Sounds as Indicators of Severity and Recovery of Lung Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location

Brief Summary:

This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).

Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.

It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.


Detailed Summary:

Respiratory problems are a significant burden to patients of all ages suffering from the most different pathologies and to their respective families, with enormous economic costs. Thus, respiratory therapies, physical (such as airway clearance therapy) or chemical (such as medication or inhalation therapies) are of increasing importance. However, little is known about the effectiveness of respiratory therapies due to the lack of accuracy, reliability and sensitivity of the current outcome measures used. Adventitious lung sounds (i.e., wheezes and crackles) have been shown to be objective, reliable measure and a sensitive indicator of minor alterations in airway geometry. Using wheezes' and crackles' analysis, the detection and characterization of the severity of the lung disease may be performed before any other measure. However, studies assessing the responsiveness to change of the ALS have never been conducted and are deemed necessary to assess if ALS are an appropriate outcome measure to overcome the problems recognized in the other clinical measures.

Therefore the main aim of this project is to assess and interpret the responses of lung sounds to respiratory interventions. To achieve this aim, high resolution computed tomography (HRCT), which is the gold standard to assess lung diseases, will be performed.

The specific aims of the study are:

  1. to explore ALS as indicators of severity and recovery of lung disease comparing acoustic data from the lungs with lung HRCT images and with the other measures i.e. breathlessness, oxygen saturation and lung function data )pre/post respiratory treatments);
  2. to explore ALS data as indicators of sputum movement comparing acoustic with imaging analysis;
  3. Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. The presence of adventitious lung sound generally indicates pulmonary disorders.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in High Resolution Computed Tomography (HRCT scans) [ Time Frame: assessment at baseline and 3 weeks after intervention ]
    Radiation levels were kept to the minimum needed to visualize the images properly and perform image computation.
  • Change in exercise tolerance [ Time Frame: assessment at baseline and 3 weeks after intervention ]
    Patients' exercise tolerance will be assessed with the 6-minute walk test. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
  • Change in activities limitation resulting from breathlessness [ Time Frame: assessment at baseline and 3 weeks after intervention ]
    The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
  • Change in lung function [ Time Frame: assessment at baseline and 3 weeks after intervention ]
    Lung function tests will be performed with a portable spirometer to assess the degree of bronchial obstruction or restriction
  • Change in peripheral oxygen saturation [ Time Frame: assessment at baseline and 3 weeks after intervention ]
    Peripheral Oxygen Saturation will be assessed with a pulse oximeter


Original Secondary Outcome: Same as current

Information By: Aveiro University

Dates:
Date Received: January 31, 2014
Date Started: September 2009
Date Completion:
Last Updated: February 3, 2014
Last Verified: February 2014