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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521677
Enrollment
108
Registered
2007-08-28
Start date
2007-09-30
Completion date
2009-10-31
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Ventilator-Associated

Keywords

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

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.

Interventions

PROCEDURESage oral care

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

Cleaning of oral cavity with menthol solution, TID

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 VAP30 days

Secondary

MeasureTime frame
30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics30 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026