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.

Study Overview

• Status: Completed
• Conditions: Oral Hygiene; Intubation, Endotracheal
• Intervention / Treatment: Other: normal saline; Drug: Chlorhexidine Gluconate

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200072
    • Changcui Qiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal Saline Group; oral wiping and oral care solution rinsing, oral care solution was 0.9% normal saline, and oral care frequency was 3 times a day.	Other: normal 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.
Experimental: Chlorhexidine group; 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.	Drug: Chlorhexidine 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.; Other Names: jinkouxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the oral microbiota	objective analysis results based on 16s RNA technology	Immediately after enrollment; 48 hrs after intubation；5 days after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Immediately after enrollment; 48 hrs after intubation；5 days after intubation
28-day mortality rate	Survival status at day 28	28 days post-randomization

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Director: sheng wang, PHD, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Endotracheal Intubation; Chlorhexidine Gluconate; 16sRNA
• Additional Relevant MeSH Terms: Anti-Infective Agents; Dermatologic Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 22K204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No