Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Diagnostic Breath Analysis
研究概览
简要总结
Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis.
Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.
详细描述
Exhaled breath samples were collected in a Tedlar bag or with a proprietary collection tube. The collection devices are clean and intended for single-use. They are manufactured with approved medical grade materials. Patients were asked to breath into a single-use, medical grade mouthpiece which is connected to the collection bag or tube. The design of the collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients enrolled in the clinical study were asked to breathe into the breath collection device for 2 to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30 days and retested at the end of the 30 day period to determine if the VOC profile has changed over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Inclusion Criteria
- •Age 18 years of age or older
- •Able to give written and dated informed consent prior to any study specific procedures.
- •Able to follow instructions for specific breathing maneuvers.
- •Able to breath into a medical grade tube, vial or bag.
- •Initial assessment and screening indicates SIRS or Sepsis.
排除标准
- •Exclusion Criteria
- •Cognitively impaired and unable to complete informed consent documents.
- •Unable to follow instructions during testing.
- •Severe dyspnea.
- •Use of supplement oxygen which cannot be discontinued during testing.
- •Unable to perform breathing maneuvers required to provide multiple breath samples.
- •Swallowing disorders or chronic aspiration.
- •History of pneumothorax.
- •Patients requiring mechanical ventilation
- •Patients who are pregnant.
- •Patients who have smoked cigarettes or cigars within 30 days prior to trial admission.
结局指标
主要结局
Diagnostic Breath Analysis
时间窗: 6 months
Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS
次要结局
未报告次要终点