Tuberc Respir Dis.  2021 Oct;84(4):291-298. 10.4046/trd.2021.0058.

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

Affiliations
  • 1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul, Republic of Korea
  • 2Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Republic of Korea
  • 3Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
  • 4Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

Abstract

Background
Endobronchial ultrasound‒guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA.
Methods
This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA.
Conclusion
This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

Keyword

EBUS-TBNA; Infectious Complication; Chlorhexidine Gluconate; Mouthrinse
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