eNose-TB: Electronic Nose for Tuberculosis Screening
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 1829
Summary
- Conditions
- Tuberculosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: The Validation phase involves suspected TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The study use a triple-blind masking, in which the research subjects, breath sample takers, and laboratory sample examiners do not know the results of each sampling that has been done. The final data processor is also blinded to the results of Xpert or other laboratory examinations. The breath sampling data is saved in graphic form which interpretation will be carried out later by the data processor at the final stage.Primary Purpose: Screening
Participation Requirements
- Age
- Between 4 years and 125 years
- Gender
- Both males and females
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 v...
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. 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.
Tracking Information
- NCT #
- NCT04567498
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yodi Mahendradhata, MD, MSc, PhD Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
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