Chlorhexidine Mouthrinse Before EBUS-TBNA (CHX_EBUS)
Status and phase
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About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
112 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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