Clinical trial NCT00521677: Comparison Between Two Methods of Oral Care on the Incidence of VAP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Keywords: VAP
Oral care
Acquired pneumonia
Mortality
LOS in ICU
LOS in hospital
All patients on ventilator in the ICU
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics
timeFrame: 30 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: General Intensive Care Unit, HaEmek MC
Study officials:
affiliation: HaEmek MC
name: Amiram Lev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HaEmek MC
name: Tzipi Yakoby, RN, MA
role: STUDY_DIRECTOR
References: