NCT04567498

eNose-TB: Electronic Nose for Tuberculosis Screening

eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,778 (actual)
• Sponsor: Gadjah Mada University · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

Summary

An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.

Detailed description

The study population consists of 2 groups: Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB. Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations. Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
OTHER	exhaled breath sampling	The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.

Timeline

• Start date: 2021-12-02
• Primary completion: 2023-02-28
• Completion: 2024-12-31
• First posted: 2020-09-28
• Last updated: 2024-07-19

Locations

3 sites across 1 country: Indonesia