NCT04718922

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 20, 2021

Last Update Submit

February 11, 2022

Conditions

Endobronchial Ultrasound

Keywords

Endobronchial ultrasoundTransbronchial needle aspirationChlorhexidineInfectionComplication

Outcome Measures

Primary Outcomes (1)

  • Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media

    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 Outcomes (3)

  • CFU counts of EBUS-TBNA needle wash solution in anaerobic media

    Needle wash solution is obtained immediately after termination of EBUS-TBNA

  • Fever

    24 hours after EBUS-TBNA

  • Infectious complications

    4 weeks after EBUS-TBNA

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min

Drug: Chlorhexidine Gluconate 0.12 % Mouthwash

Control Arm

NO INTERVENTION

No mouthrinse

Interventions

Chlorhexidine Gluconate 0.12 % MouthwashDRUG

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

Also known as: Hexamedine Sol.
Experimental Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe

You may not qualify if:

  • immunocompromised;
  • trachemostomy status;
  • who have already undergone gastroscopy on the same day when EBUS- TBNA is scheduled to be administered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

  • Kim NY, Park JH, Park J, Kwak N, Choi SM, Park YS, Lee CH, Cho J. Effect of chlorhexidine Mouthrinse on prevention of microbial contamination during EBUS-TBNA: a randomized controlled trial. BMC Cancer. 2022 Dec 20;22(1):1334. doi: 10.1186/s12885-022-10442-5.

    PMID: 36539736DERIVED

  • Kim NY, Park JH, Park J, Kwak N, Choi SM, Park YS, Lee CH, Cho J. Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial. Tuberc Respir Dis (Seoul). 2021 Oct;84(4):291-298. doi: 10.4046/trd.2021.0058. Epub 2021 Jun 24.

    PMID: 34162198DERIVED

MeSH Terms

Conditions

Infections

Interventions

chlorhexidine gluconateMouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jaeyoung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

January 20, 2021

Primary Completion

June 11, 2021

Study Completion

December 11, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

KR(1)