Tracheobronchitis, Ventilator Associated Pneumonia
Conditions
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.
Interventions
DRUG0.12% chlorhexidine gluconate
The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
DRUGPlacebo
The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
Sponsors
Karabuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathogen colonization change | change from baseline pathogen colonization at Day 3 | We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions) |
| Oral assessment guide score change | 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 | 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 ) |
| rate of tracheobronchitis change | change from baseline the rate of tracheobronchitis at Day 3 | Questionary (use the rate of tracheobronchitis categories) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cost effectiveness | Day 30 | We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions. |
| Mortality | Day 7 and Day 28 | rate of mortality |
Countries
Turkey (Türkiye)
Outcome results
None listed