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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min |
|
| Control Arm | No Intervention | No mouthrinse |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate 0.12 % Mouthwash | Drug | Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media | Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle. | Needle wash solution is obtained immediately after termination of EBUS-TBNA |
| Measure | Description | Time Frame |
|---|---|---|
| CFU counts of EBUS-TBNA needle wash solution in anaerobic media | Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle. | Needle wash solution is obtained immediately after termination of EBUS-TBNA |
| Fever |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaeyoung Cho, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36539736 | Derived | Kim NY, Park JH, Park J, Kwak N, Choi SM, Park YS, Lee CH, Cho J. Effect of chlorhexidine Mouthrinse on prevention of microbial contamination during EBUS-TBNA: a randomized controlled trial. BMC Cancer. 2022 Dec 20;22(1):1334. doi: 10.1186/s12885-022-10442-5. | |
| 34162198 | Derived | Kim NY, Park JH, Park J, Kwak N, Choi SM, Park YS, Lee CH, Cho J. Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial. Tuberc Respir Dis (Seoul). 2021 Oct;84(4):291-298. doi: 10.4046/trd.2021.0058. Epub 2021 Jun 24. |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
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|
Fever is defined as a temperature ≥37.8°C. |
| 24 hours after EBUS-TBNA |
| Infectious complications | Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis. | 4 weeks after EBUS-TBNA |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |