eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,778
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Inclusion Criteria:
- •Validation Phase (Group 1):
- •Adult and children
- •Suspected of having TB
- •Agree to participate in the study
- •Able to produce exhaled air samples
- •Able to produce samples for Xpert MTB/Rif examination
- •Screening Phase (Group 2):
- •Adult and children
- •Agree to participate in the study
- •Able to produce exhaled air samples
- •Currently not in TB treatment
排除标准
- •Invalid measurements of breath tests
- •Incomplete CXR data
- •Missing specimens
- •Unable to breath normally for 2 minutes due to respiratory illness
结局指标
主要结局
Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV
时间窗: 2 years
sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy
Access barriers, measured through questionnaire, interview, and focus group discussion
时间窗: 2 years
access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion
次要结局
- Time of a screening algorithm with eNose-TB, measured in days(2 years)
研究者
Antonia Morita Iswari Saktiawati
Lecturer
Gadjah Mada University