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

HaEmek Medical Center, Israel

Status: Completed

Conditions: Pneumonia, Ventilator-Associated

Treatments: Procedure: Traditional oral care; Procedure: Sage oral care

Study type: Interventional

Funder types: Other

Identifiers

NCT00521677

VAP1

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: Sage oral care

2

Active Comparator group

Description:

The traditional method of oral care with cleaning of the oral cavity with a sponge soaked with antiseptic non alcoholic solution

Treatment:

Procedure: Traditional oral care