Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Bacterial Colonization (Gram stain)
研究概览
简要总结
This single-centre, single-blind, randomised controlled study with parallel-group design was conducted in Yun Ling, Taiwan between May 2019 and August 2019. Participants were randomly allocated to an intervention (mouth care using 0.12% CHX before intubation) or control (standard care) group on a 1:1 basis. This study was approved by the institutional review board of National Taiwan University Hospital, Taiwan (IRB No.201806086RINB). Each participant completed written informed consent after explanation of this study and advised that they could withdraw anytime.
详细描述
Participants were recruited at the operation room of a teaching hospital. Participants were included if they met the following criteria: 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia. Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia.
排除标准
- •Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated, >1 during anesthesia processes,
结局指标
主要结局
Bacterial Colonization (Gram stain)
时间窗: after removal of endotracheal tube at recovery room (15 minutes after surgery ended)
Bacterial Colonization
次要结局
- Breathing odor assessment using questionnaire(after removal of endotracheal tube and at recovery room (15 minutes after surgery ended))
- Breathing odor assessment using halitosis detector(after removal of endotracheal tube and at recovery room (15 minutes after surgery ended))