Efficacy of Chlorhexidine Mouth Wash in ICU Ventilated Patients: Microbiological Effects and Antiseptic Residual Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- changes over time of bacterial growth
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in patients' saliva at the same time-points after CMW.
详细描述
Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Although many guidelines and expert opinions recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in the saliva at the same time-points after CMW.
In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine solution.
Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2 hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial growth.
In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.
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
- •critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours
- •Non-inclusion criteria:
- •cervical or mouth surgery in the last 15 days;
- •history of oropharyngeal neoplasm or of cervical or oropharyngeal radiotherapy,
- •tracheotomy,
- •age under 18
排除标准
- •Patients whose samples retrieved less than 10 to the 3 colony forming unit (CFU)/mL bacteria and those who had two or more missing microbiological samples were secondarily excluded
结局指标
主要结局
changes over time of bacterial growth
时间窗: 6 hours (360 minutes)
oropharyngeal colonization (i.e., amount of bacterial growth in each oropharyngeal sample) before and after a mouth wash with chlorhexidine will be measured at different time points (before (H0) and 15 minutes, 60 minutes, 120 minutes, 240 minutes, and 360 minutes after the mouth wash with chlorhexidine)
次要结局
- changes over time of bacterial growth of each bacterial specie(6 hours (360 minutes))
- salivary concentration of chlorhexidine(6 hours (360 minutes))
- susceptibility of isolates to chlorhexidine(1 hour)
研究者
Prof Jean-Damien RICARD
Professor of Intensive Care
Hôpital Louis Mourier