Mechanical Ventilation for More Than 48 Hours.
Conditions
Brief summary
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Detailed description
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Interventions
Bexident® (0.12% chlorhexidine solution)
DRUGPlacebo
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
Sponsors
Sinaloa Pediatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 1 month to 18 years admitted to the intensive care unit. * Intubated for more than 48 hours.
Exclusion criteria
* Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation. * Allergy to chlorhexidine. * Known immune deficiency. Elimination Criteria: * Transfer to another hospital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ventilator associated pneumonia | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks |
| Days of mechanical ventilation | From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks |
| Length of stay | From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks |
Countries
Mexico
Contacts
Primary ContactJesus J Martinez, MD
Backup ContactLuz I Zamudio, MD
Outcome results
None listed