E-Nose: Diagnostic Tool for Pleural TB

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Utility of the E-Nose for Pleural TB

Conditions
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Tuberculosis, Pleural

Intervention / Treatment
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* Other: Medical History
* Device: E-Nose
* Other: Chest CT
* Other: Pleural Fluid Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution. More than 15 years old. Pleural effusion of any etiology Exclusion Criteria: Severe compromise of the general condition Not capable to exhaled through the E-nose. No possibility to follow-up. By discretion of the research team.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pleural TB<br>This group consist of patients with TB pleural effusion. Intervention: Inform Consent Medical History E-Nose Device Chest CT Cytomorphologic & Cytochemistry of pleural Fluid. Adenosine Deaminase value of pleural Fluid. | Other: Medical History<br>* Oriented Survey and complete physical exam.<br>Device: E-Nose<br>* 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<br>Other: Chest CT<br> <br> Other: Pleural Fluid Analysis<br>* Cytomorphology Cytochemistry Adenosine Deaminase Value<br>|
| Active Comparator: Control<br>Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: Inform Consent Medical History E-Nose Device Chest CT Cytomorphologic & Cytochemistry of pleural Fluid. Adenosine Deaminase value of pleural Fluid. | Other: Medical History<br>* Oriented Survey and complete physical exam.<br>Device: E-Nose<br>* 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<br>Other: Chest CT<br> <br> Other: Pleural Fluid Analysis<br>* Cytomorphology Cytochemistry Adenosine Deaminase Value<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects related to the use of the device, according to the CTCEA |  | 1 year |