Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Differences in pathogenic bacteria in the oropharynx and lower airways
研究概览
简要总结
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.
For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.
Randomisation
- No prophylaxis
- Preparation with a probiotic suspension before intubation.
Cultures
-
oropharynx
-
before treatment
-
after intubation
-
before extubation
-
day 1 postoperatively
-
tracheal secretions
-
after intubation
-
before extubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients
- •Planned interventions
- •Anaesthesia > 4 hours and requiring intubation
排除标准
- •Ulcers in the mouth, oropharynx, oesophagus and stomach
- •Current infections in the airways
- •Known immuno deficiences
- •Emergency cases
结局指标
主要结局
Differences in pathogenic bacteria in the oropharynx and lower airways
时间窗: During hospitalization, up to 4 weeks
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention
次要结局
- Pneumonia(Up till 7 days postoperatively)
- Length of hospital stay(time to discharged from hospital or patients death)
- CRP(During hospitalization, up to 4 weeks)
- White blood cells(During hospitalization, up to 4 weeks)