Clinical trial NCT04718922: Chlorhexidine Mouthrinse Before EBUS-TBNA
Official title: Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endobronchial Ultrasound
Keywords: Endobronchial ultrasound
Transbronchial needle aspiration
Chlorhexidine
Infection
Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media
timeFrame: Needle wash solution is obtained immediately after termination of EBUS-TBNA
Secondary outcomes:
measure: CFU counts of EBUS-TBNA needle wash solution in anaerobic media
timeFrame: Needle wash solution is obtained immediately after termination of EBUS-TBNA
measure: Fever
timeFrame: 24 hours after EBUS-TBNA
measure: Infectious complications
timeFrame: 4 weeks after EBUS-TBNA
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jaeyoung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.