Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Volatile Organic Compound profile
研究概览
简要总结
This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.
详细描述
The aim of this study is to sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant. By using infrared spectroscopy, the breath sample analysis will help investigators describe and identify patterns of VOCs that are over- or under-represented in patients with post-lung transplant rejection when compared to the breath profiles of those without rejection. It is hypothesized that the profile of volatile chemicals in the breath of patients in the early stages of rejection will differ significantly from those individuals without rejection.
Primary objective
• To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematical/statistical models of infrared absorption spectrum for identification of rejection.
Secondary objective
- To determine the best method to classify health status based on VOC data of breath samples
- To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Patient is able to give informed consent
- •Lung transplant patient who had both lungs transplanted
- •Patient is at least 90 days after their lung transplant
- •Patient is able to provide a breath sample
排除标准
- •Patient is less than 18 years old
- •Patient received multiple organ transplants
- •Patient had an organ transplant prior to their lung transplant
- •Patients who received a single lung transplant
- •Patient less than 90 days or more than 1 year from their lung transplant
- •If patient has smoked 4 hours or less before breath sample or consumed alcohol (including mouthwash) 8 hours or less before breath sample
结局指标
主要结局
Volatile Organic Compound profile
时间窗: three to twelve months post-transplant
The VOCs in the breath of patients experiencing lung rejection post-transplant per bronchoscopy will be compared to lung transplant patients who are not experiencing rejection
次要结局
未报告次要终点