Comparison Between Two Methods of Oral Care on the Incidence of VAP
Recruitment status was Not yet recruiting
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.
Procedure: Sage oral care
Procedure: Traditional oral care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Incidence of acquired pneumonia in ventilated patients in the ICU [ Time Frame: 30 days or as a long as patients on ventilator in the ICU ]
- 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics [ Time Frame: 30 days ]
|Study Start Date:||September 2007|
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|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521677
|Contact: Amiram Lev, MD||+972-4-6494179 ext firstname.lastname@example.org|
|Contact: Tzipi Yakoby, RN, MA||+972-4-6494080 ext email@example.com|
|General Intensive Care Unit, HaEmek MC||Not yet recruiting|
|Afula, Israel, 18101|
|Contact: Tzipi Yakoby, RN MA +972-4-6494080 ext 4080 firstname.lastname@example.org|
|Contact: Amiram Lev, MD +972-4-6494179 ext 4179 email@example.com|
|Principal Investigator: Amiram Lev, MD|
|Sub-Investigator: Tzipi Yakoby, RN, MA|
|Principal Investigator:||Amiram Lev, MD||HaEmek MC|
|Study Director:||Tzipi Yakoby, RN, MA||HaEmek MC|