Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 30
- 主要终点
- Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
研究概览
简要总结
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.
This ancillary study will be performed in 14 centers participating to the DEMETER study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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 over 18 years
- •Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- •Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage will be available during the SSD period of the trial
- •Information delivered
排除标准
- •Previous inclusion in the study
- •Patients moribund at the Intensive Care Unit admission
- •Pregnant, parturient or breast-feeding woman
- •Patient hospitalized without consent and/or deprived of liberty by court's decision
- •Patient under guardianship or curators
- •Lack of social insurance
- •Concomitant inclusion in a trial on VAP prevention
- •Patient with no comprehension of the French language
结局指标
主要结局
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
时间窗: Until weaning of mechanical ventilation, an expected average of 10 days
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.
次要结局
- Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP(Until weaning of mechanical ventilation, an expected average of 10 days)
- Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance(Until weaning of mechanical ventilation, an expected average of 10 days)
- Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance(Until weaning of mechanical ventilation, an expected average of 10 days)