E-Nose: Diagnostic Tool for Pleural TB

Universidad Central de Venezuela

Status: Unknown

Conditions: Tuberculosis, Pleural

Treatments: Other: Chest CT; Device: E-Nose; Other: Medical History; Other: Pleural Fluid Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02765087

EN002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
2. More than 15 years old.
3. Pleural effusion of any etiology

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pleural TB

Experimental group

Description:

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.

Treatment:

Other: Medical History

Other: Pleural Fluid Analysis

Device: E-Nose

Other: Chest CT

Control

Active Comparator group

Description:

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.

Treatment:

Other: Medical History

Other: Pleural Fluid Analysis

Device: E-Nose

Other: Chest CT