Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karabuk University
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Pathogen colonization change
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental group
0.12% chlorhexidine gluconate
Intervention: 0.12% chlorhexidine gluconate (Drug)
Placebo group
sodium bicarbonate
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pathogen colonization change
Time Frame: change from baseline pathogen colonization at Day 3
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
rate of tracheobronchitis change
Time Frame: change from baseline the rate of tracheobronchitis at Day 3
Questionary (use the rate of tracheobronchitis categories)
Oral assessment guide score change
Time Frame: at the time of admission into the study (day 0), at study day 2 and at day 3
The score ranges from 8 to 24 and higher scores indicating worse oral health
Clinical pulmonary infection score change
Time Frame: at the time of admission into the study (day 0), at study day 2 and at day 3
The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )
Secondary Outcomes
- Mortality(Day 7 and Day 28)
- cost effectiveness(Day 30)
Investigators
Duygu Kes
Principal Investigator
Karabuk University