Chlorhexidine Mouthrinse Before EBUS-TBNA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-12-11

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).

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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.

Conditions

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Endobronchial Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Arm

Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min

Group Type EXPERIMENTAL

Chlorhexidine Gluconate 0.12 % Mouthwash

Intervention Type DRUG

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

Control Arm

No mouthrinse

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorhexidine Gluconate 0.12 % Mouthwash

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

Intervention Type DRUG

Other Intervention Names

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Hexamedine Sol.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No