Comparison Between Two Methods of Oral Care on the Incidence of VAP
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|ClinicalTrials.gov Identifier: NCT00521677|
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : June 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Ventilator-Associated||Procedure: Sage oral care Procedure: Traditional oral care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||October 2009|
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
Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
Active Comparator: 2
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
Cleaning of oral cavity with menthol solution, TID
Other Name: Tarodent
- 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 [ Time Frame: 30 days ]
- 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521677
|General Intensive Care Unit, HaEmek MC|
|Afula, Israel, 18101|
|Principal Investigator:||Amiram Lev, MD||HaEmek MC|
|Study Director:||Tzipi Yakoby, RN, MA||HaEmek MC|