Back to resultsEffect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
Primary Purpose
Ventilator Associated Pneumonia, Tracheobronchitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
0.12% chlorhexidine gluconate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Admission in critical care with in 24 hours
- Having an endotracheal tube
Exclusion Criteria:
- History of chlorhexidine allergy
- Duration of mechanichal ventilation less than 48 h
- Confirmed diagnosis of pneumonitis before admission in the ICU
- Transfer from another ICU
- Receiving chemotherapy or radiotherapy
- Patients with immunodeficiency
- Patients with tracheostomies
- Required specific oral hygiene procedures
- Facio-maxillary or dental trauma/surgery
- Being pregnant
Sites / Locations
- Karabük University Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
0.12% chlorhexidine gluconate
sodium bicarbonate
Outcomes
Primary Outcome Measures
Pathogen colonization change
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
Oral assessment guide score change
The score ranges from 8 to 24 and higher scores indicating worse oral health
Clinical pulmonary infection score change
The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )
rate of tracheobronchitis change
Questionary (use the rate of tracheobronchitis categories)
Secondary Outcome Measures
cost effectiveness
We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.
Mortality
rate of mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04505202
Brief Title
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
Official Title
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.
Detailed Description
The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Tracheobronchitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
0.12% chlorhexidine gluconate
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
sodium bicarbonate
Intervention Type
Drug
Intervention Name(s)
0.12% chlorhexidine gluconate
Intervention Description
The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sodium bicarbonate
Intervention Description
The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
Primary Outcome Measure Information:
Title
Pathogen colonization change
Description
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
Time Frame
change from baseline pathogen colonization at Day 3
Title
Oral assessment guide score change
Description
The score ranges from 8 to 24 and higher scores indicating worse oral health
Time Frame
at the time of admission into the study (day 0), at study day 2 and at day 3
Title
Clinical pulmonary infection score change
Description
The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )
Time Frame
at the time of admission into the study (day 0), at study day 2 and at day 3
Title
rate of tracheobronchitis change
Description
Questionary (use the rate of tracheobronchitis categories)
Time Frame
change from baseline the rate of tracheobronchitis at Day 3
Secondary Outcome Measure Information:
Title
cost effectiveness
Description
We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.
Time Frame
Day 30
Title
Mortality
Description
rate of mortality
Time Frame
Day 7 and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Admission in critical care with in 24 hours
Having an endotracheal tube
Exclusion Criteria:
History of chlorhexidine allergy
Duration of mechanichal ventilation less than 48 h
Confirmed diagnosis of pneumonitis before admission in the ICU
Transfer from another ICU
Receiving chemotherapy or radiotherapy
Patients with immunodeficiency
Patients with tracheostomies
Required specific oral hygiene procedures
Facio-maxillary or dental trauma/surgery
Being pregnant
Facility Information:
Facility Name
Karabük University Training and Research Hospital
City
Karabük
State/Province
Karabuk
ZIP/Postal Code
78050
Country
Turkey
12. IPD Sharing Statement
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Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
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