NCT02583308已完成不适用
Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 896
- 试验地点
- 30
- 主要终点
- Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
研究概览
简要总结
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.
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 (SSD) 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
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
时间窗: Until weaning of mechanical ventilation, an expected average of 10 days
次要结局
- Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
- Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.(Until weaning of mechanical ventilation, an expected average of 10 days)
研究者
研究点 (30)
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