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

NCT06691841 | Completed DMC

• 1 other identifier: 22K204
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation, Endotracheal; Oral Hygiene

Keywords

Chlorhexidine Gluconate; Endotracheal Intubation; 16sRNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• oral complications

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

• plaque Index

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

• whether VAP occurs

  Immediately after enrollment; 48 hrs after intubation；5 days after intubation

• 28-day mortality rate

  28 days post-randomization

Study Arms (2)

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.

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.

Drug: Chlorhexidine Gluconate

Interventions

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.

Also known as: jinkouxin

Chlorhexidine group

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.

Normal Saline Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Changcui Qiu

Shanghai, 200072, China

Location

Related Publications (1)

• 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. doi: 10.1186/s12903-025-07579-7. Online ahead of print.

  PMID: 41456054 DERIVED

MeSH Terms

Interventions

chlorhexidine gluconate; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• sheng wang, PHD

  Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: November 15, 2024
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-09

Locations

CN (1)