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

Na Young Kim, Jae Hyeon Park, Jimyung Park, Nakwon Kwak, Sun Mi Choi, Young Sik Park, Chang-Hoon Lee, Jaeyoung Cho, Na Young Kim, Jae Hyeon Park, Jimyung Park, Nakwon Kwak, Sun Mi Choi, Young Sik Park, Chang-Hoon Lee, Jaeyoung Cho

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).

Keywords: Chlorhexidine Gluconate; EBUS-TBNA; Infectious Complication; Mouthrinse.

Conflict of interest statement

Conflicts of Interest

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1.
Fig. 1.
Two cases of mediastinal adenitis following endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). (A–D) A 77-year-old man diagnosed with stage IIB (pT3N0M0) non-small cell lung cancer. (A) Chest computed tomography (CT) scan showed enlargement of the left lower paratracheal lymph node (station 4L) where EBUS-TBNA was performed 22 days previously and diffuse wall thickening of the adjacent trachea. (B) An inflammatory nodule and mucosal edema of the left lateral wall of the lower trachea were observed with flexible bronchoscopy on day 33 after EBUS-TBNA. Biopsy of the nodule revealed chronic active inflammation and fibrosis. (C) Chest CT scan on day 50; after antibiotic treatment, the lymph node decreased in size. (D) Bronchoscopic image on day 78; the inflammatory nodule and mucosal edema of the lower trachea had disappeared. (E–H) A 68-year-old man diagnosed with stage IA2 (cT1bN0M0) small cell lung cancer. (E) Chest CT scan showed enlargement of the lower paratracheal lymph nodes (station 4R and 4L) where EBUS-TBNA was performed 15 days previously and diffuse wall thickening of the adjacent trachea. (F) Inflammatory nodules and mucosal edema of the lower tracheal wall were observed by bronchoscopy on day 16 after EBUS-TBNA. (G) After antibiotic treatment, the lymph nodes decreased slightly in size, the inflammatory nodules and mucosal edema of the lower trachea were improving on day 26 (H).
Fig. 2.
Fig. 2.
Flow diagram of the trial. CFU: colony forming unit; EBUS-TBNA: endobronchial ultrasound-guided transbronchial needle aspiration.
Fig. 3.
Fig. 3.
Participant timeline. CFU: colony forming unit; EBUS-TBNA: endobronchial ultrasound-guided transbronchial needle aspiration.
Fig. 4.
Fig. 4.
Overview of study procedures. *Tissue diagnosis can be done by transthoracic needle aspiration, radial probe EBUS, or diagnostic flexible bronchoscopy with endobronchial biopsy or transbronchial lung biopsy. CFU: colony forming unit; CT: computed tomography; EBUS-TBNA: endobronchial ultrasound-guided transbronchial needle aspiration; FDG: fluorodeoxyglucose; MRI: magnetic resonance imaging; PET: positron emission tomography.

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