Chlorhexidine Mouthrinse Before EBUS-TBNA

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial

Conditions
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Endobronchial Ultrasound

Intervention / Treatment
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* Drug: Chlorhexidine Gluconate 0.12 % Mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min | Drug: Chlorhexidine Gluconate 0.12 % Mouthwash<br>* Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA<br>* Other names: Hexamedine Sol.;|
| No Intervention: Control Arm<br>No mouthrinse | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial ultrasound, Transbronchial needle aspiration, Chlorhexidine, Infection, Complication