Chlorhexidine Mouthrinse Before EBUS-TBNA

Phase 4

Completed

• Conditions: Endobronchial Ultrasound
• Interventions: Drug: Chlorhexidine Gluconate 0.12 % Mouthwash

• Registration Number: NCT04718922
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2021-06-11
• Study Completion: 2021-12-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Chlorhexidine Gluconate 0.12 % Mouthwash	Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of