Chlorhexidine Mouthrinse Before EBUS-TBNA

Endobronchial Ultrasound Clinical Trial

— CHX_EBUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718922
• Other study ID #: 20110961173
• Status: Completed
• Phase: Phase 4
• Start date: January 20, 2021
• Est. completion date: December 11, 2021

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endobronchial Ultrasound

Intervention

Drug:
• Chlorhexidine Gluconate 0.12 % Mouthwash
Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fever	Fever is defined as a temperature =37.8°C.	24 hours after EBUS-TBNA
Secondary	Infectious complications	Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.	4 weeks after EBUS-TBNA