Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Changes in the oral microbiota
研究概览
简要总结
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology.
详细描述
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology. Between September 2022 and March 2023, 68 patients admitted to the ICU for endotracheal intubation were collected. They were randomly divided into intervention group and control group, with 34 cases in each group. The control group used the method of wiping, washing and saline (0.9%) three times a day, and the intervention group was using the method of wiping, washing and 0.12% chlorhexidine gluconate three times a day.The results were analyzed at three time points before the first oral care after intubation, before oral care 48 hours after intubation, and before oral care on the 5th day after intubation.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years; ② Complete clinical data; ③ Expected duration of orotracheal intubation for mechanical ventilation exceeding 5 days.
排除标准
- •Patients with abnormal coagulation function, severe respiratory burns, oral surgery, lung and systemic infections; ② Patients expected to die within 48 hours after extubation; ③ Patients with actual duration of orotracheal intubation for mechanical ventilation less than 5 days.
- •Exclusion During Study:
- •Failure to follow the prescribed plan; ② Incomplete data; ③ Patients who voluntarily withdraw from treatment during the study.
研究组 & 干预措施
Normal Saline Group
oral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and oral care frequency was 3 times a day.
干预措施: normal saline (Other)
Chlorhexidine group
oral wiping and oral care solution rinsing, oral care solution was 0.12% Chlorhexidine gluconate solution, and oral care frequency was 3 times a day.
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Changes in the oral microbiota
时间窗: Immediately after enrollment; 48 hrs after intubation；5 days after intubation
objective analysis results based on 16s RNA technology
次要结局
- oral complications(mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention)
- plaque Index(mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention)
- whether VAP occurs(Immediately after enrollment; 48 hrs after intubation；5 days after intubation)
- 28-day mortality rate(28 days post-randomization)
研究者
Sheng Wang MD PhD
director
Shanghai 10th People's Hospital