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

Pneumonia, Ventilator-Associated Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521677
• Other study ID #: VAP1
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: June 21, 2015
• Start date: September 2007
• Est. completion date: October 2009

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Procedure:
• Sage oral care
Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
• Traditional oral care
Cleaning of oral cavity with menthol solution, TID

Locations

Country	Name	City	State
Israel	General Intensive Care Unit, HaEmek MC	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics		30 days	No