Diagnostic Utility of the E-Nose for Pleural TB
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Severe compromise of the general condition
- •Not capable to exhaled through the E-nose.
- •No possibility to follow-up.
- •By discretion of the research team.
研究组 & 干预措施
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.
干预措施: Medical History (Other)
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.
干预措施: E-Nose (Device)
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.
干预措施: Chest CT (Other)
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.
干预措施: Pleural Fluid Analysis (Other)
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.
干预措施: Medical History (Other)
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.
干预措施: E-Nose (Device)
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.
干预措施: Chest CT (Other)
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.
干预措施: Pleural Fluid Analysis (Other)
结局指标
主要结局
Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
时间窗: 1 year
次要结局
- Adverse Effects related to the use of the device, according to the CTCEA(1 year)
研究者
Jacobus H. de Waard
Chief of Tuberculosis Laboratory
Universidad Central de Venezuela