Application of Nanotechnology and Chemical Sensors for Lung Diseases by Respiratory Samples
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Volatile organic compounds signature measured by mass spectrometer and electronic signal measured by the electronic nose, difference between the study groups at one and 12 months
研究概览
简要总结
The investigators assume that by analysis of different volatile organic compounds in the breath, using nanotechnology, the investigators will be able to identify a unique respiratory signature of different diseases including asthma, chronic obstructive pulmonary disease (COPD) and pulmonary hypertension.
详细描述
Five groups of patients will be included in the study; each group will include 50-75 patients:
Group -1 - Healthy volunteer, will use as a control. Group -2 - Patients diagnosed as having diastolic heart failure with normal pulmonary artery pressure by echocardiography.
Group - 3 - Patients diagnosed with diastolic heart failure and out of proportion pulmonary hypertension confirm by right heart failure.
Group - 4 - Patients diagnosed with chronic obstructive lung disease. Group- 5 Patients diagnosed with asthma Demographic and clinical data will be collected for each patient. Exhaled alveolar air will be collected from each test groups. Samples will be collected using a breath collection method developed according to the recommendations of the American Thoracic Society, which effectively avoids artifacts and systematic errors. Two bags will be collected from each person tested: One for gas chromatograph analysis, and another one for analysis with the sensor array.
In order to achieve a artificial nose that has high sensitivity towards the unique breath markers of patients with specific disease, we will follow a 5-phase approach. In phase-1 we will collect suitable breath samples from each patient and compare the patient data to age-adjusted healthy controls. In phase-2 we will analyze the collected breath samples with the electronic nose setup. These breath samples are our training set. In phase-3 we will carry out auxiliary chemical analysis, using gas-chromatography linked with mass spectrometry of the breath samples under different aspects. Phase-4 will aim at the improvement of our electronic nose setup and will be conducted in parallel to the first three phases. The main steps of this phase will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of asthma according to the American Thoracic Society guidelines.
- •Diagnosis of chornic obstructive pulmonary disease according to the American Thoracic Society, guidelines.
- •Diagnosis of pulmoanry hypertension according to the American Thoracic Society guidelins
- •Age-18-85 year old
排除标准
- •known carriers of infectious diseases: HIV, hepatitis B, C
- •History of lung cancer
结局指标
主要结局
Volatile organic compounds signature measured by mass spectrometer and electronic signal measured by the electronic nose, difference between the study groups at one and 12 months
时间窗: up to 12 months
次要结局
未报告次要终点