CHX_EBUS: Chlorhexidine Mouthrinse Before EBUS-TBNA

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04718922

Collaborator

(none)

112

Enrollment

Location

Arms

10.7

Actual Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Endobronchial Ultrasound	Drug: Chlorhexidine Gluconate 0.12 % Mouthwash	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 20, 2021

Actual Primary Completion Date :

Jun 11, 2021

Actual Study Completion Date :

Dec 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min	Drug: Chlorhexidine Gluconate 0.12 % Mouthwash Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA Other Names: Hexamedine Sol.
No Intervention: Control Arm No mouthrinse

Arm

Intervention/Treatment

Experimental: Experimental Arm

Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min

Drug: Chlorhexidine Gluconate 0.12 % Mouthwash

Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA

Other Names:

Hexamedine Sol.

No Intervention: Control Arm

No mouthrinse

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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