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ACTIVE NOT RECRUITING
NCT07283380
NA

Effect of Two Oral Care Methods on Oral Flora and VAP in Mechanically Ventilated Patients

Sponsor: Marmara University

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to evaluate the effect of two oral care methods on oral bacterial colonization and ventilator-associated pneumonia (VAP) in mechanically ventilated intensive care unit (ICU) patients. The study will be conducted in the Anesthesia and General Intensive Care Unit of a hospital in Turkey between October 2025 and June 2026. A total of 72 patients who meet the inclusion criteria and provide informed consent will be randomly assigned to two groups. Thirty-six patients will receive oral care with a pediatric toothbrush, and 36 patients will receive oral care with a sponge stick, for five consecutive days. Standardized oral care sets containing 0.12% chlorhexidine, recommended for VAP prevention, will be used in both groups. Oral health and oral care frequency will be assessed daily using the "Oral Care Assessment Scale in Intensive Care Patients (OCAS-ICP)" developed by the researchers. Oral swabs will be collected on Day 1 and Day 6 and analyzed in the microbiology laboratory for colonization with Staphylococcus spp., Pseudomonas spp., and Acinetobacter spp. The Clinical Pulmonary Infection Score (CPIS) will be used to monitor the development of VAP, including six parameters: fever, leukocytes, tracheal secretions, oxygenation, chest radiography, and culture results. Patients will be evaluated on Days 1 and 6 for changes in oral flora and VAP occurrence. This study will provide evidence on the effectiveness of different oral care devices in preventing VAP and improving oral health in mechanically ventilated ICU patients.

Official title: Investigation of the Effect of Two Different Oral Care Methods on Oral Flora and Ventilator Associated Pneumonia in Mechanically Ventilated Patients: A Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-10-01

Completion Date

2026-10-01

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DEVICE

Pediatric toothbrush

Oral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored.

DEVICE

Sponge stick

Oral care will be using a sponge stick for 5 days; oral swabs and CPIS scores will be monitored.

Locations (2)

Zonguldak Ataturk State Hospital

Zonguldak, Turkey (Türkiye)

Zonguldak Atatürk State Hospital, Ministry of Health, Türkiye

Zonguldak, Turkey (Türkiye)