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NCT Number: NCT06691841

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

Evaluation of the application effect of compound chlorhexidine gargle in oral care of patients with endotracheal intubation based on 16s RNA technology.

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Key information

Conditions

Intubation, Endotracheal Oral Hygiene

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changcui Qiu

Shanghai, 200072, China

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine gluconate

Drug

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.

Other names: jinkouxin

Normal Saline

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. oral complications

    Time frame: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention

    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.

  2. plaque Index

    Time frame: mechanical ventilation at 0 hours, 2 days, and 5 days post-intervention

    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.

  3. whether VAP occurs

    Time frame: Immediately after enrollment; 48 hrs after intubation；5 days after intubation

    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.

  4. 28-day mortality rate

    Time frame: 28 days post-randomization

    Survival status at day 28

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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