Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
研究概览
简要总结
To determine if the analysis of exhaled breath condensate correlates with the development & resolution of pneumonia.
详细描述
This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age 18 or older
- •Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
- •Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)
排除标准
- •Less than 18 years of age
- •Expected survival less than 24 hours
- •Anticipated extubation within 24 hours of enrollment
- •Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 > 80%; PEEP > 16 cmH2O; Intracranial pressure >20 cmH2O; Tracheal or mucosal bleeding; Platelet count < 20,000 cells/uL; INR > 2.0
- •Known prisoners
- •Pneumonia diagnosis at the time of ICU admission
结局指标
主要结局
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
时间窗: enrollment to hospital day 15
To determine the association between the microbial community in both EBCF specimens and bronchoalveolar lavage fluid (BALF) samples in critically ill and injured, mechanically ventilated patients suspected of VAP.
The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.
时间窗: enrollment to hospital day 15
To develop a robust predictive model for the development of VAP and its resolution based on changes in the microbial community in EBCF collected over the course of ventilation.
次要结局
未报告次要终点
研究者
Wonder Drake
Professor
Vanderbilt University Medical Center