The Effect of Solutions Used in Oral Care on Preventing Ventilator-Associated Pneumonia.

Ventilator-Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118242
• Other study ID #: AdnanMU-NDH-OZDEMIR-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: November 2023
• Source: Aydin Adnan Menderes University
• Contact: Sercan OZDEMIR
• Phone: +905438169496
• Email: sercanoz15[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: June 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

Other:
• Use of oral care solutions
Oral care solutions to be used: Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid

Locations

Country	Name	City	State
Turkey	Nazilli State Hospital	Aydin	Yesil

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator associated pneumonia	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.	one week