Lower Respiratory Tract Infections Clinical Trial
Official title:
Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
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.
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. to explore respiratory physiotherapy effectiveness in patients with LTRI.
The plan is to recruit approximately 100 voluntary patients with LRTI attending to casualty
at a central hospital. This study will enroll adult patients diagnosed with LRTI according
to the international guidelines. The age and pathology of the participants have been chosen
because i) adult patients are easier to collaborate; ii) there is some characterization
based on ALS of adult patients allowing future comparisons; iii) this pathology normally
benefit from medical and respiratory physiotherapy treatments as soon as the diagnose is
made, but in Portugal do not often received respiratory physiotherapy. Furthermore, these
patients will be able to cooperate with the data collection, namely with the imaging
techniques, which is fundamental to assess the responsiveness to change of a measure.
Patients will be recruited via the physician, who will provide brief explanation of the
study. Then, the researcher will contact interested participants to provide more detailed
information and obtained the consent forms. Patients' who agree to participate will be
randomly assigned to the conventional treatment group or the conventional treatment plus
respiratory physiotherapy group (approximately 50 patients in each group).
Baseline data will be collected within the first 24 hours of patients' visit to the
hospital. The researcher will collect some clinical information, socio-demographic,
anthropometric, breathlessness and peripheral oxygen saturation of all participants. A
multi-channel system with 7 microphones (attached to the patients' chest) will be connected
to a laptop and will be used to record the lung sounds data. Patients will then lie down in
supine on the machine plinth and a HRCT scan of the chest will be acquired. Lung function
and exercise tolerance data will then be recorded.
Patients in the experimental group will receive daily medical treatment and respiratory
physiotherapy 3 times a week, during 2 weeks (average time to treat the LRTI). Respiratory
physiotherapy will consist of breathing retraining and chest clearance techniques, exercises
for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and
education about the disease. This program will be adjusted to each individual needs. After
this period all measurements will be repeated. Furthermore, all measures with the exception
of the chest images will also be performed before/after each respiratory physiotherapy
session to monitor the intervention. Each session will be conducted in property equipped
rooms and will last approximately 60 minutes.
To identify change in the lung sounds, statistical techniques (e.g. ALS, intra-class
correlation coefficient, Bland and Altmand 95% limits of agreements and smallest real
difference) will be used. The relationship between the images and the sounds will be
explored and defined analytically and quantitatively. To analyse changes in outcome
measures, data from the two groups will be compared at baseline and 3 weeks after the
intervention.
The data analysis will be undertaken using proprietary software packages (e.g.Matlab, SPSS)
and will include the generation of descriptive statistics, and the use of existing and
custom routines for hypothesis testing and signal processing and analysis.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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