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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation

Conditions
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Ventilator Associated Pneumonia, Tracheobronchitis

Intervention / Treatment
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* Drug: 0.12% chlorhexidine gluconate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>0.12% chlorhexidine gluconate | Drug: 0.12% chlorhexidine gluconate<br>* The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care<br>|
| Placebo Comparator: Placebo group<br>sodium bicarbonate | Drug: Placebo<br>* The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care<br>* Other names: sodium bicarbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogen colonization change | We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions) | 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 | 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 ) | 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) | change from baseline the rate of tracheobronchitis at Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost effectiveness | We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions. | Day 30 | 
| Mortality | rate of mortality | Day 7 and Day 28 |