E-Nose: Diagnostic Tool for Pleural TB

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.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis, Pleural
• Intervention / Treatment: Other: Medical History; Device: E-Nose; Other: Chest CT; Other: Pleural Fluid Analysis

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Poli, MD; Phone Number: +584265172608; Email: sergio.polid@gmail.com

Study Locations

• Venezuela
  • DC
    • Caracas, DC, Venezuela, 1020
      • Recruiting
      • Instituto de Biomedicina
      • Contact: Sergio Poli, MD; Phone Number: +584265172608; Email: sergio.polid@gmail.com
      • Principal Investigator: Jacobus de Waard, PhD.
      • Sub-Investigator: Luisa Quesada, MD
      • Sub-Investigator: Sergio Poli, MD
      • Sub-Investigator: Emines Salas, BsBio
      • Sub-Investigator: Fernando Poli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pleural TB; 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; 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
ACTIVE_COMPARATOR: Control; 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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Central de Venezuela
• Collaborators: The ENose Company, Zutphen, Netherlands; Foundation for Research in Mycobacteria (FUNDAIM)
• Investigators: Principal Investigator: Jacobuss de Waard, PhD., Instituto de Biomedicina

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (ESTIMATE): May 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 12, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pleural Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pleural
• Other Study ID Numbers: EN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO