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

NCT ID: NCT00521677

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-10-31

Brief Summary

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

Pneumonia, Ventilator-Associated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Sage oral care

Intervention Type: PROCEDURE

Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID

2

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

Group Type: ACTIVE_COMPARATOR

Traditional oral care

Intervention Type: PROCEDURE

Cleaning of oral cavity with menthol solution, TID

Interventions

Sage oral care

Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID

Intervention Type: PROCEDURE

Traditional oral care

Cleaning of oral cavity with menthol solution, TID

Intervention Type: PROCEDURE

Other Intervention Names

Tarodent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amiram Lev, MD

Role: PRINCIPAL_INVESTIGATOR

HaEmek MC

Tzipi Yakoby, RN, MA

Role: STUDY_DIRECTOR

HaEmek MC

Locations

General Intensive Care Unit, HaEmek MC

Afula, , Israel

Countries

Israel

Other Identifiers

VAP1

Identifier Type: -

Identifier Source: org_study_id