Comparison Between Two Methods of Oral Care on the Incidence of VAP
Primary Purpose
Pneumonia, Ventilator-Associated
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Sage oral care
Traditional oral care
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Ventilator-Associated focused on measuring VAP, Oral care, Acquired pneumonia, Mortality, LOS in ICU, LOS in hospital, All patients on ventilator in the ICU
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
Sites / Locations
- General Intensive Care Unit, HaEmek MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
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.
The traditional method of oral care with cleaning of the oral cavity with a sponge soaked with antiseptic non alcoholic solution
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics
Full Information
NCT ID
NCT00521677
First Posted
August 27, 2007
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00521677
Brief Title
Comparison Between Two Methods of Oral Care on the Incidence of VAP
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated
Keywords
VAP, Oral care, Acquired pneumonia, Mortality, LOS in ICU, LOS in hospital, All patients on ventilator in the ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
The traditional method of oral care with cleaning of the oral cavity with a sponge soaked with antiseptic non alcoholic solution
Intervention Type
Procedure
Intervention Name(s)
Sage oral care
Intervention Description
Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
Intervention Type
Procedure
Intervention Name(s)
Traditional oral care
Other Intervention Name(s)
Tarodent
Intervention Description
Cleaning of oral cavity with menthol solution, TID
Primary Outcome Measure Information:
Title
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amiram Lev, MD
Organizational Affiliation
HaEmek MC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tzipi Yakoby, RN, MA
Organizational Affiliation
HaEmek MC
Official's Role
Study Director
Facility Information:
Facility Name
General Intensive Care Unit, HaEmek MC
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Two Methods of Oral Care on the Incidence of VAP
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