Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT04718922
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).
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Notify Me19 year and older
All sexes
Interventional
Phase 4
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA
Other names: Hexamedine Sol.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after EBUS-TBNA
Fever is defined as a temperature ≥37.8°C.
Time frame: 4 weeks after EBUS-TBNA
Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.
Seoul National University Hospital
Other
Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial
Acronym: CHX_EBUS
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