Endobronchial Ultrasound
Conditions
Keywords
Endobronchial ultrasound, Transbronchial needle aspiration, Chlorhexidine, Infection, Complication
Brief summary
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).
Detailed 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.
Interventions
Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CFU counts of EBUS-TBNA needle wash solution in anaerobic media | 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. |
| Fever | 24 hours after EBUS-TBNA | Fever is defined as a temperature ≥37.8°C. |
| Infectious complications | 4 weeks after EBUS-TBNA | Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis. |
Countries
South Korea
Outcome results
None listed