Endobronchial UltrasoundPhase 4CHX_EBUSNCT04718922
Chlorhexidine Mouthrinse Before EBUS-TBNA
A Phase 4 study testing Chlorhexidine Gluconate 0.12 % Mouthwash in people with Endobronchial Ultrasound, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Endobronchial Ultrasound
- What is being tested?
- Chlorhexidine Gluconate 0.12 % Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2021to 11 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Endobronchial Ultrasound
- Being tested
- Chlorhexidine Gluconate 0.12 % Mouthwash
- Keywords
- Endobronchial ultrasound, Transbronchial needle aspiration, Chlorhexidine, Infection, Complication
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate 0.12 % MouthwashDrug
Also called Hexamedine Sol.
Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min Receives: Drug: Chlorhexidine Gluconate 0.12 % Mouthwash |
| Control Arm | No intervention | No mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 by instilling 5mL of sterile physiological saline into the puncture needle.
Measured: Needle wash solution is obtained immediately after termination of EBUS-TBNA
Fever
Fever is defined as a temperature ≥37.8°C.
Measured: 24 hours after EBUS-TBNA
Infectious complications
Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.
Measured: 4 weeks after EBUS-TBNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Jan 2021
- Primary completion11 Jun 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endobronchial UltrasoundStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaeyoung Cho, Seoul National University Hospital
- Investigators
- Jaeyoung Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718922
- Sponsor's protocol ID
- 20110961173
- Acronym
- CHX_EBUS
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36539736Kim 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.
PubMed 34162198
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04718922
- Acronym / sponsor ID
- CHX_EBUS / 20110961173
- Conditions
- Endobronchial Ultrasound
- Keywords
- Endobronchial ultrasound, Transbronchial needle aspiration, Chlorhexidine, Infection, Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Chlorhexidine Gluconate 0.12 % MouthwashMouthrinse with 100 ml 0.12% chlorhexidine for 1 min |
| Control Arm | No intervention | –No mouthrinse |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Gluconate 0.12 % MouthwashAlso: Hexamedine Sol.Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA | Drug | Experimental Arm |
Primary outcome
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.
3 secondary outcomes
CFU counts of EBUS-TBNA needle wash solution in anaerobic media
Time frame: Needle wash solution is obtained immediately after termination of EBUS-TBNA
Fever
Time frame: 24 hours after EBUS-TBNA
Infectious complications
Time frame: 4 weeks after EBUS-TBNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 36539736Kim 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.
- Derived from this study: PubMed 34162198Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaeyoung Cho, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate 0.12 % Mouthwash in people with Endobronchial Ultrasound, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718922, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.