Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Volatile Organic Compound (VOC) Pattern
研究概览
简要总结
Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.
详细描述
Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test.
The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to Emergency Department
- •suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
- •age 18 or older
排除标准
- •member of Vulnerable Patient Population
- •unable to complete Patient Informed Consent process/document
研究组 & 干预措施
Breath sample collection
干预措施: Breath sample collection (Device)
结局指标
主要结局
Volatile Organic Compound (VOC) Pattern
时间窗: five minutes
Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic.
次要结局
未报告次要终点