Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: 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
- 66
- 试验地点
- 2
- 主要终点
- Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
研究概览
简要总结
Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. Whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. The DEMETER study assessing the medico-economical impact of the subglottic secretions drainage study (NCT02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine.
This ancillary study will be performed in one of the 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
- Single (Care Provider)
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 (MV) delivered via an endotracheal tube and MV required more than 72 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 ICU 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
研究组 & 干预措施
Period with endotracheal tubes not allowing SSD
During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions
干预措施: Endotracheal tubes not allowing SSD (Device)
Period with endotracheal tubes allowing SSD
During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
干预措施: Endotracheal tubes allowing SSD (Device)
结局指标
主要结局
Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
时间窗: Day 3 of mechanical ventilation
次要结局
- Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD(Day 3 of mechanical ventilation)
- Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.(Day 28 of mechanical ventilation)
- Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD(Day 3 of mechanical ventilation)
- Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.(Day 28 of mechanical ventilation)