Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Antibiotic Usage or Exposure
研究概览
简要总结
The proposed study will evaluate adult patients admitted to the medical or surgical intensive care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal aspirate culture arm, which is the current test available at SFGH.
详细描述
Patients will be randomized to either Mini-Bal or tracheal aspirate then samples will be taken to the lab for culture. Comparative analysis will then be performed based upon lab results.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •All adult patients (> age 18) admitted to 5E, 5R, and 4E intensive care units and are on the ventilator for greater than 48 hours and expected to remain on the ventilator for awhile
- •Study procedures would be performed only in patients clinically suspected of having VAP.
排除标准
- •Severe respiratory distress at the time of suspected VAP defined by:
- •FiO2 ≥ 0.7
- •PEEP ≥ 12
结局指标
主要结局
Change in Antibiotic Usage or Exposure
时间窗: It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics
We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have \>80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).
Antibiotics Exposure Days
时间窗: 15 days
We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure
次要结局
未报告次要终点