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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Ventilator-Associated
• Intervention / Treatment: Procedure: Sage oral care; Procedure: Traditional oral care

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • General Intensive Care Unit, HaEmek MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: Tarodent

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Amiram Lev, MD, HaEmek MC; Study Director: Tzipi Yakoby, RN, MA, HaEmek MC

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 27, 2007
• First Submitted That Met QC Criteria: August 27, 2007
• First Posted (Estimate): August 28, 2007

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Mortality; Oral care; VAP; Acquired pneumonia; LOS in ICU; LOS in hospital; All patients on ventilator in the ICU
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: VAP1