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Completed

NCT Number: NCT04718922

Chlorhexidine Mouthrinse Before EBUS-TBNA

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine Gluconate 0.12 % Mouthwash

Drug

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

Other names: Hexamedine Sol.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Fever

    Time frame: 24 hours after EBUS-TBNA

    Fever is defined as a temperature ≥37.8°C.

  3. Infectious complications

    Time frame: 4 weeks after EBUS-TBNA

    Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: CHX_EBUS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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