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

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06118242
Collaborator
(none)
105
1
2
19
5.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Use of oral care solutions
N/A

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
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid Solutions Used in Oral Care on Preventing Ventilator-Associated Pneumonia.
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 15, 2024
Anticipated Study Completion Date :
Jun 15, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ventilator associated pneumonia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nazilli State Hospital Aydın Yesil Turkey 09800

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sercan Özdemir, Register Nurse, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT06118242
Other Study ID Numbers:
  • AdnanMU-NDH-OZDEMIR-001
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sercan Özdemir, Register Nurse, Aydin Adnan Menderes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023