Comparison Between Two Methods of Oral Care on the Incidence of VAP

Study Overview
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Brief Summary
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Patients on ventilator are in high risk to develop ventilator associated pneumonia (VAP). This acquired infection significantly increases morbidity and mortality of these patients. Studies that investigated the factors influencing the incidence of VAP proved that infectious agents located in the throat and oral cavity are important factors. The assimilation of oral cavity treatment, including teeth brushing, cleaning and removal of secretions may significantly decrease the incidence of VAP. Choosing the method of oral cavity cleaning is based on few studies that demonstrated the optimal influence of combining mechanical cleansing, the use of a non alcoholic antiseptic material and lubrication of the lips and the oral cavity. Most of these studies are retrospective. The study will compare the traditional method of oral cavity treatment with the use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity. The current study is a prospective, open label, statistically balanced study that will investigate the connection between the method of oral cavity treatment and the incidence of VAP. 100 patients will be included. All ventilated patients in the ICU will be eligible and will be included after an informed consent will be signed by the patient, or by his legal guardian. Exclusion criteria include age less than 18 y/o, pregnancy, expected survival of less than 48 hours, immunosupression (excluding patients on steroids), severe burns, existing pneumonia and patient already included in another study. The main outcome will be 30 days all cause mortality. Secondary outcomes include the development of VAP, days on ventilator, LOS in the ICU and LOS in the hospital.

Conditions
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Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Procedure: Sage oral care
* Procedure: Traditional oral care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ventilated patients in the ICU Older than 18 y/o Exclusion Criteria: Age less than 18 years Pregnancy Immunosuperessed patients Expected survival of less than 48 hours Burns Existing pneumonia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Procedure: Use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity. | Procedure: Sage oral care<br>* Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID<br>|
| Active Comparator: 2<br>The traditional method of oral care with cleaning of the oral cavity with a sponge soaked with antiseptic non alcoholic solution | Procedure: Traditional oral care<br>* Cleaning of oral cavity with menthol solution, TID<br>* Other names: Tarodent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of oral care, including teeth brush and oral cavity cleaning with non alcoholic solution in ventilated ICU patients, on the incidence of VAP |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAP, Oral care, Acquired pneumonia, Mortality, LOS in ICU, LOS in hospital, All patients on ventilator in the ICU