Tuberculosis, Pleural Clinical Trial
Official title:
Diagnostic Utility of the E-Nose for Pleural TB
The purpose of this study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the current gold standard.
The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose'
for Pleural TB, which is a Extra pulmonary TB form.
The patient who qualified for the study, according to the inclusion criteria, after
consenting, will be guided through and oriented survey for risk factors, then a complete
physical exam, and after that, the patient will breathe for 5 minutes trough the device,
which stores the patient information, that later will be download to a computer and will be
send to the server's manufacturer company, in Netherlands.
During and after the use of the device, investigators determine the adverse effects of the
intervention, according to the CTCEA.
Investigators use the pleural biopsy, which is the gold standard, to determine the diagnostic
utility of the test. And, will compare the results with other tests currently perform as the
regular diagnostic routine, such as Chest CT, adenosine deaminase value of pleural fluid and
cytomorphologic & cytochemistry of the pleural fluid.
Patient Registries will be keep in an electronic database, as well as handwriting history,
with the backup copy in the records of the hospital in which the patient was admitted.
Auditories will be realised by the Ethics Committee in different time frames.
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