Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 16
- 主要终点
- contribution to diagnosis and/or therapeutic decision
研究概览
简要总结
Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed.
The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.
详细描述
Secondary objectives will be to
- assess the frequency of poor quality bronchoalveolar lavages (as defined by either more than 5% bronchial epithelial cell count to less than 50,000 alveolar cells per mL)
- assess the contribution of a given bronchoalveolar lavage to the diagnostic work up
- assess the contribution of a given bronchoalveolar lavage results to therapeutic decision
- assess the induced short term respiratory side effects
- identify risk factors for poor respiratory tolerance
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adult patient (> 18 yr-old) hospitalized in intensive care unit with acute and/or chronic lung disease that need bronchoalveolar lavage as part of routine diagnostic work up
- •patient's or family consent
排除标准
- •consent not obtained
- •patient already included at previous bronchoalveolar lavage of during previous hospitalization
- •absence of social security number
- •age < 18yr
- •pregnant woman
结局指标
主要结局
contribution to diagnosis and/or therapeutic decision
时间窗: 72 hours
Investigators will be ask to answer the following question: Did the bronchoalveolar lavage results contribute to diagnosis and/or therapeutic decision: Yes or No
quality of performed bronchoalveolar lavage
时间窗: 72 hours
pathologists examining bronchoalveolar lavage specimen will classify bronchoalveolar lavage as "of poor quality" or of "good quality" based upon cytologic assessment: bronchial cell count (not more than 5%) and alveolar cell count (above 50,000/mL).
frequency of use
时间窗: 72 hours
the frequency of use of bronchoalveolar lavage will be describe and expressed as the proportion of patients who underwent bronchoalveoalr lavage upon the total number of patients admitted in the recruiting intensive care units during the study period
次要结局
- Evolution of respiratory rate(24 hours)
- Evolution of oxygen needs(24 hours)
- Need of tracheal intubation(24 hours)