Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media
研究概览
简要总结
The purpose of this study is to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
详细描述
EBUS-TBNA using the convex probe is a standard of care for the assessment of mediastinal and hilar lymphadenopathy. Although EBUS-TBNA is a minimally invasive procedure, rare but serious infectious complications such as pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis were reported. EBUS-scope might be contaminated with oropharyngeal commensal bacteria while passing the oropharyngeal airway during EBUS-TBNA. Contamination of punctured lymph nodes by oropharyngeal commensal bacteria can cause severe infections.
Chlorhexidine gluconate is an antimicrobial agent that has a broad antibacterial activity including both gram-positive and negative bacteria. Chlorhexidine has been widely used for surgical scrub, skin disinfection, and mouthrinse. We, therefore, designed a phase 4, single-center, randomized, controlled clinical trial to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during EBUS-TBNA.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe
排除标准
- •antiseptic mouthrinse within 7 days before inclusion;
- •active infection or antibiotic treatment within 7 days before inclusion;
- •immunocompromised;
- •trachemostomy status;
- •who have already undergone gastroscopy on the same day when EBUS- TBNA is scheduled to be administered
研究组 & 干预措施
Experimental Arm
Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min
干预措施: Chlorhexidine Gluconate 0.12 % Mouthwash (Drug)
结局指标
主要结局
Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media
时间窗: Needle wash solution is obtained immediately after termination of EBUS-TBNA
Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle.
次要结局
- CFU counts of EBUS-TBNA needle wash solution in anaerobic media(Needle wash solution is obtained immediately after termination of EBUS-TBNA)
- Fever(24 hours after EBUS-TBNA)
- Infectious complications(4 weeks after EBUS-TBNA)
研究者
Jaeyoung Cho
Assistant Professor
Seoul National University Hospital