Intubation, EndotrachealNCT06691841
Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology
A study testing Chlorhexidine Gluconate and normal saline in people with Intubation, Endotracheal and Oral Hygiene, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intubation, Endotracheal, Oral Hygiene
- What is being tested?
- Chlorhexidine Gluconate and normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Mar 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years; ② Complete clinical data; ③ Expected duration of orotracheal intubation for mechanical ventilation exceeding 5 days.
Who cannot join
- Patients with abnormal coagulation function, severe respiratory burns, oral surgery, lung and systemic infections; ② Patients expected to die within 48 hours after extubation; ③ Patients with actual duration of orotracheal intubation for mechanical ventilation less than 5 days.
- Failure to follow the prescribed plan; ② Incomplete data; ③ Patients who voluntarily withdraw from treatment during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology.
Read the detailed description
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology. Between September 2022 and March 2023, 68 patients admitted to the ICU for endotracheal intubation were collected. They were randomly divided into intervention group and control group, with 34 cases in each group. The control group used the method of wiping, washing and saline (0.9%) three times a day, and the intervention group was using the method of wiping, washing and 0.12% chlorhexidine gluconate three times a day.The results were analyzed at three time points before the first oral care after intubation, before oral care 48 hours after intubation, and before oral care on the 5th day after intubation.
- Conditions
- Intubation, Endotracheal, Oral Hygiene
- Being tested
- Chlorhexidine Gluconate, normal saline
- Keywords
- Chlorhexidine Gluconate, Endotracheal Intubation, 16sRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Also called jinkouxin
oral wiping and oral care solution rinsing, oral care solution was 0.12% chlorhexidine gluconate, and the frequency of oral care was 3 times a day.
normal salineOther
oral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and the frequency of oral care was 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Group | Other | oral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and oral care frequency was 3 times a day. Receives: Other: normal saline |
| Chlorhexidine group | Experimental | oral wiping and oral care solution rinsing, oral care solution was 0.12% Chlorhexidine gluconate solution, and oral care frequency was 3 times a day. Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the oral microbiota
objective analysis results based on 16s RNA technology
Measured: Immediately after enrollment; 48 hrs after intubation；5 days after intubation
Secondary outcomes (4)
oral complications
Oral complication occurrences: The occurrences of oral mucosa bleeding, oral inflammation, oral ulcers, fungal and herpes virus infections, tongue falling backwards, laryngeal edema, granulomas, and other complications were recorded in elderly patients undergoing mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention. Diagnosis was confirmed through blood routine tests, histopathological examinations, smear tests, fungal cultures, or other methods.
Measured: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention
plaque Index
Dental Plaque Index: The mesial buccal, middle buccal, distal buccal, and lingual surfaces of the teeth in elderly patients undergoing mechanical ventilation were examined and scored using a combination of visual inspection and probing. A score of 0 indicates no plaque at the gingival margin, 1 indicates a thin layer of plaque at the gingival margin, 2 indicates moderate plaque at the gingival margin or interproximal area, and 3 indicates abundant soft debris within the gingival sulcus, at the gingival margin, and in the interproximal area. The Dental Plaque Index is calculated as the sum of the plaque scores for each tooth divided by the total number of teeth examined.
Measured: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention
whether VAP occurs
the recorder records whether VAP occurs after endotracheal intubation;Ventilator-associated pneumonia (VAP) refers to pneumonia that occurs between 48 hours after the initiation of mechanical ventilation (MV) and 48 hours after extubation. It is an important type of hospital-acquired pneumonia (HAP). Among them, pneumonia that occurs within 4 days of MV is classified as early-onset VAP, while that occurring on or after the 5th day is classified as late-onset VAP.
Measured: Immediately after enrollment; 48 hrs after intubation；5 days after intubation
28-day mortality rate
Survival status at day 28
Measured: 28 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Sep 2022
- Primary completion1 May 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation, EndotrachealStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Wang MD PhD, Shanghai 10th People's Hospital
- Investigators
- sheng wang, PHD, Study director, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691841
- Sponsor's protocol ID
- 22K204
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qiu C, Tang L, Hang Z, Wei K, Wang S, Zhu X, Wang Q. Effect of chlorhexidine vs. saline for oral care on oral microbiota and prognosis of elderly mechanically ventilated patients in the intensive care unit: a single-center, single-blind, randomized controlled trial. BMC Oral Health. 2025 Dec 28;26(1):199. doi: 10.1186/s12903-025-07579-7.
PubMed 41456054
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology
- ClinicalTrials.gov ID
- NCT06691841
- Acronym / sponsor ID
- 22K204
- Conditions
- Intubation, Endotracheal, Oral Hygiene
- Keywords
- Chlorhexidine Gluconate, Endotracheal Intubation, 16sRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Nov 2024 (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.
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology.
Detailed description
Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology. Between September 2022 and March 2023, 68 patients admitted to the ICU for endotracheal intubation were collected. They were randomly divided into intervention group and control group, with 34 cases in each group. The control group used the method of wiping, washing and saline (0.9%) three times a day, and the intervention group was using the method of wiping, washing and 0.12% chlorhexidine gluconate three times a day.The results were analyzed at three time points before the first oral care after intubation, before oral care 48 hours after intubation, and before oral care on the 5th day after intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Group | Other | Other: normal salineoral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and oral care frequency was 3 times a day. |
| Chlorhexidine group | Experimental | Drug: Chlorhexidine Gluconateoral wiping and oral care solution rinsing, oral care solution was 0.12% Chlorhexidine gluconate solution, and oral care frequency was 3 times a day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age ≥ 65 years; ② Complete clinical data; ③ Expected duration of orotracheal intubation for mechanical ventilation exceeding 5 days.
Key exclusion criteria (2 listed)
- Patients with abnormal coagulation function, severe respiratory burns, oral surgery, lung and systemic infections; ② Patients expected to die within 48 hours after extubation; ③ Patients with actual duration of orotracheal intubation for mechanical ventilation less than 5 days.
- Failure to follow the prescribed plan; ② Incomplete data; ③ Patients who voluntarily withdraw from treatment during the study.
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 GluconateAlso: jinkouxinoral wiping and oral care solution rinsing, oral care solution was 0.12% chlorhexidine gluconate, and the frequency of oral care was 3 times a day. | Drug | Chlorhexidine group |
| normal salineoral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and the frequency of oral care was 3 times a day. | Other | Normal Saline Group |
Primary outcome
Changes in the oral microbiota
Time frame: Immediately after enrollment; 48 hrs after intubation；5 days after intubation
objective analysis results based on 16s RNA technology
4 secondary outcomes
oral complications
Time frame: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention
plaque Index
Time frame: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention
whether VAP occurs
Time frame: Immediately after enrollment; 48 hrs after intubation；5 days after intubation
28-day mortality rate
Time frame: 28 days post-randomization
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 Nov 2024.
- Derived from this study: PubMed 41456054Qiu C, Tang L, Hang Z, Wei K, Wang S, Zhu X, Wang Q. Effect of chlorhexidine vs. saline for oral care on oral microbiota and prognosis of elderly mechanically ventilated patients in the intensive care unit: a single-center, single-blind, randomized controlled trial. BMC Oral Health. 2025 Dec 28;26(1):199. doi: 10.1186/s12903-025-07579-7.
- Individual participant dataSharing planned: Undecided
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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.
sheng wang, PHD study director
Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate and normal saline in people with Intubation, Endotracheal and Oral Hygiene, run by Shanghai 10th People's Hospital at 1 site in China.
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 2 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 Nov 2024. 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 China. 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.
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?
Changes in the oral microbiota (time frame: Immediately after enrollment; 48 hrs after intubation；5 days after intubation). 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 NCT06691841, which also lists 1 linked publication.
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 Nov 2024.