Chlorhexidine Mouthrinse Before EBUS-TBNA (CHX_EBUS)

February 11, 2022 updated by: Jaeyoung Cho, Seoul National University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media
Time Frame: 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.
Needle wash solution is obtained immediately after termination of EBUS-TBNA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CFU counts of EBUS-TBNA needle wash solution in anaerobic media
Time Frame: 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.
Needle wash solution is obtained immediately after termination of EBUS-TBNA
Fever
Time Frame: 24 hours after EBUS-TBNA
Fever is defined as a temperature ≥37.8°C.
24 hours after EBUS-TBNA
Infectious complications
Time Frame: 4 weeks after EBUS-TBNA
Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.
4 weeks after EBUS-TBNA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

December 11, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110961173

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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