NCT02765087

E-Nose: Diagnostic Tool for Pleural TB

Diagnostic Utility of the E-Nose for Pleural TB

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universidad Central de Venezuela · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tuberculosis, Pleural

Interventions

Type	Name	Description
OTHER	Medical History	Oriented Survey and complete physical exam.
DEVICE	E-Nose	Patient will breath trough the device for 5 minutes, and during and after the intervention will be assessed for adverse effects related to the use of the e-Nose, according to the CTCEA
OTHER	Chest CT
OTHER	Pleural Fluid Analysis	Cytomorphology Cytochemistry Adenosine Deaminase Value

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-05-06
• Last updated: 2017-11-14

Locations

1 site across 1 country: Venezuela