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Clinical Trials/NCT06118242
NCT06118242Not yet recruitingNot Applicable

The Effect of Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid Solutions Used in Oral Care on Preventing Ventilator-Associated Pneumonia.

Aydin Adnan Menderes University2 sites in 1 country105 target enrollmentStarted: November 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
105
Locations
2
Primary Endpoint
Ventilator associated pneumonia

Study Overview

Brief Summary

The goal of this clinical trial is to learn about effects of chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions used in oral care of patients on mechanical ventilation support on preventing ventilator associated pneumonia.

The main question[s] it aims to answer are:

Is there any difference between 1% chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions versus 0.12% chlorhexidine gluconate solution used in oral care in preventing the development of VAP? Is there any difference between 1% chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions versus 0.12% chlorhexidine gluconate solution used in oral care in preventing the development of VAP?

Researchers will compare 1% chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions to see if VAP

Detailed Description

Many problems may develop in patients on mechanical ventilation support in intensive care units. The most important of these is ventilator-associated pneumonia (VAP) caused by inadequate oral care in patients on mechanical ventilator support. The aim of the thesis is to examine the effect of chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions used in oral care in preventing ventilator-associated pneumonia in patients on mechanical ventilation support.

This research was planned as a randomized controlled experimental study. The sample of the study will consist of 105 intubated adult patients hospitalized in the Anesthesia and Reanimation Intensive Care Unit of the Republic of Turkey Ministry of Health Aydın Provincial Health Directorate Nazilli State Hospital. Patients will be divided into a total of 5 groups: 4 experimental and 1 control group. The groups to which 1% chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid solutions are applied will constitute the experimental group, and the patients who receive oral care with 0.12% chlorhexidine gluconate, which is routinely applied in the clinic, will constitute the control group. Patients will be given oral care by the nurse with determined solutions (chlorhexidine gluconate, sodium bicarbonate, ozonated water and hypochlorous acid) 4 times a day according to the oral care protocol, and the oral mucosa of all patient groups will be evaluated every morning for 7 days. A deep tracheal aspirate sample will be taken and a chest x-ray will be taken on the first and seventh days after hospitalization of intubated patients. The development of VAP in patients will be evaluated with the clinical pulmonary infection score.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Being over 18 years of age
  • Being under mechanical ventilation treatment for at least 24 hours
  • Agreeing to participate in the research

Exclusion Criteria

  • Patients who are extubated
  • Patients transferred to another clinic
  • Those who did not agree to participate in the research

Outcomes

Primary Outcomes

Ventilator associated pneumonia

Time Frame: one week

We will used the commonly used clinical pulmonary infection score (CPIS), which includes temperature, leucocyte count and morphology, amount of tracheal secretions and their character, alveolar oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio, findings of pulmonary infiltration and progression on chest X-ray, and growth of any pathogenic bacterial growth from the tracheal aspirate. Whereas the CPIS score of \>6 or 6 suggests VAP.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sercan Özdemir

Register Nurse

Aydin Adnan Menderes University

Study Sites (2)

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