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

NCT00521677 | Completed DMC

• 1 other identifier: VAP1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

VAP; Oral care; Acquired pneumonia; Mortality; LOS in ICU; LOS in hospital; All patients on ventilator in the ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics

  30 days

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

Sage oral care PROCEDURE

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

1

Traditional oral care PROCEDURE

Cleaning of oral cavity with menthol solution, TID

Also known as: Tarodent

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ventilated patients in the ICU
• Older than 18 y/o

You may not qualify if:

• Age less than 18 years
• Pregnancy
• Immunosuperessed patients
• Expected survival of less than 48 hours
• Burns
• Existing pneumonia

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

General Intensive Care Unit, HaEmek MC

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amiram Lev, MD

  HaEmek MC

  PRINCIPAL INVESTIGATOR

• Tzipi Yakoby, RN, MA

  HaEmek MC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

IL (1)