E-Nose: Diagnostic Tool for Pleural TB

Not Applicable

• Conditions: Tuberculosis, Pleural
• Interventions: Other: Medical History; Device: E-Nose; Other: Chest CT; Other: Pleural Fluid Analysis

• Registration Number: NCT02765087
• Lead Sponsor: Universidad Central de Venezuela

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. Severe compromise of the general condition
2. Not capable to exhaled through the E-nose.
3. No possibility to follow-up.
4. By discretion of the research team.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pleural TB	E-Nose	This group consist of patients with TB pleural effusion. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Control	Pleural Fluid Analysis	Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Pleural TB	Pleural Fluid Analysis	This group consist of patients with TB pleural effusion. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Control	E-Nose	Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Pleural TB	Medical History	This group consist of patients with TB pleural effusion. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Control	Medical History	Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Pleural TB	Chest CT	This group consist of patients with TB pleural effusion. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.
Control	Chest CT	Patients with pleural effusion with different aetiologies than Tuberculosis. Intervention: 1. Inform Consent 2. Medical History 3. E-Nose Device 4. Chest CT 5. Cytomorphologic \& Cytochemistry of pleural Fluid. 6. Adenosine Deaminase value of pleural Fluid.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse Effects related to the use of the device, according to the CTCEA	1 year

Trial Locations

Locations (1)

Instituto de Biomedicina; 🇻🇪 Caracas, DC, Venezuela