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

NCT06118242 | Unknown

• 1 other identifier: AdnanMU-NDH-OZDEMIR-001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilator-Associated Pneumonia

Keywords

Oral Hygiene; Mechanical Ventilation; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Results Related to Ventilator-Associated Pneumonia in Patients

EXPERIMENTAL

Use of 0.12% Chlorhexidine Gluconate,1% Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid.

Other: Use of oral care solutions

Results Regarding the Oral Mucous Membrane Integrity of Patients

EXPERIMENTAL

Use of 1% Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid.

Other: Use of oral care solutions

Interventions

Use of oral care solutions OTHER

Oral care solutions to be used: Chlorhexidine Gluconate, Sodium Bicarbonate, Ozonated Water and Hypochlorous Acid

Results Regarding the Oral Mucous Membrane Integrity of Patients; Results Related to Ventilator-Associated Pneumonia in Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Nazilli State Hospital

Aydin, Yesil, 09800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülengün TÜRK, Prf. Dr

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Central Study Contacts

Sercan OZDEMİR

CONTACT

+905438169496; sercanoz15@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Register Nurse

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: November 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: June 15, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)