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Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology

Effect of Chlorhexidine Gluconate in Oral Care of Patients With Endotracheal Intubation Based on 16sRNA Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06691841
Enrollment
76
Registered
2024-11-15
Start date
2022-09-01
Completion date
2024-03-01
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Endotracheal, Oral Hygiene

Keywords

Chlorhexidine Gluconate, Endotracheal Intubation, 16sRNA

Brief summary

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.

Interventions

DRUGChlorhexidine Gluconate

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.

OTHERnormal saline

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.

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 65 years; ② Complete clinical data; ③ Expected duration of orotracheal intubation for mechanical ventilation exceeding 5 days.

Exclusion criteria

* 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. Exclusion During Study: * Failure to follow the prescribed plan; ② Incomplete data; ③ Patients who voluntarily withdraw from treatment during the study.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the oral microbiotaImmediately after enrollment; 48 hrs after intubation;5 days after intubationobjective analysis results based on 16s RNA technology

Secondary

MeasureTime frameDescription
oral complicationsmechanical ventilation at 0 hours, 2 days, and 5 days post-interventionOral 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.
plaque Indexmechanical ventilation at 0 hours, 2 days, and 5 days post-interventionDental 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.
whether VAP occursImmediately after enrollment; 48 hrs after intubation;5 days after intubationthe 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.
28-day mortality rate28 days post-randomizationSurvival status at day 28

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026