Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications

Karabuk University57 enrolled

Overview

Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Ventilator Associated Pneumonia Tracheobronchitis

Interventions

0.12% chlorhexidine gluconateDRUG

The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care

PlaceboDRUG

The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Admission in critical care with in 24 hours * Having an endotracheal tube Exclusion Criteria: * History of chlorhexidine allergy * Duration of mechanichal ventilation less than 48 h * Confirmed diagnosis of pneumonitis before admission in the ICU * Transfer from another ICU * Receiving chemotherapy or radiotherapy * Patients with immunodeficiency * Patients with tracheostomies * Required specific oral hygiene procedures * Facio-maxillary or dental trauma/surgery * Being pregnant

Locations (1)

Karabük University Training and Research Hospital

Karabük, Karabük Province, Turkey (Türkiye)

Outcomes

Primary Outcomes

Pathogen colonization change

We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)

Time frame: change from baseline pathogen colonization at Day 3

Oral assessment guide score change

The score ranges from 8 to 24 and higher scores indicating worse oral health

Time frame: at the time of admission into the study (day 0), at study day 2 and at day 3

Clinical pulmonary infection score change

The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )

Time frame: at the time of admission into the study (day 0), at study day 2 and at day 3

rate of tracheobronchitis change

Questionary (use the rate of tracheobronchitis categories)

Time frame: change from baseline the rate of tracheobronchitis at Day 3

Secondary Outcomes

cost effectiveness

We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.

Time frame: Day 30

Mortality

rate of mortality

Time frame: Day 7 and Day 28

Data from ClinicalTrials.gov

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