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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator-Associated Pneumonia
• Intervention / Treatment: Other: Use of oral care solutions

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 Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sercan OZDEMİR; Phone Number: +905438169496; Email: sercanoz15@hotmail.com

Study Locations

• Turkey
  • Yesil
    • Aydın, Yesil, Turkey, 09800
      • Nazilli State Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Results Related to Ventilator-Associated Pneumonia in Patients; Use of 0.12% Chlorhexidine Gluconate,1% Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid.	Other: Use of oral care solutions; Oral care solutions to be used: Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid
Experimental: Results Regarding the Oral Mucous Membrane Integrity of Patients; Use of 1% Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid.	Other: Use of oral care solutions; Oral care solutions to be used: Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Director: Gülengün TÜRK, Prf. Dr, Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Intensive Care Units; Oral Hygiene
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: AdnanMU-NDH-OZDEMIR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No