Objective: To study the efficacy of oral mucosal decontamination with chlorhexidine gel for the prevention of ventilator-associated pneumonia in children between 3 months and 15 yrs.
Design: Double blind randomized placebo controlled trial.
Setting: Pediatric intensive care unit of a tertiary care hospital in North India.
Patients: Eligible participants were patients aged 3 months to 15 yrs who required orotracheal or nasotracheal intubation and mechanical ventilation. Two hundred eighty-three children admitted to the pediatric intensive care unit between November 2007 and April 2009 were screened. Eighty-six patients fulfilled the study requirements.
Intervention: Either 1% chlorhexidine or placebo gel was applied on the buccal mucosa at 8-hr intervals for the entire duration of ventilation, subject to a maximum of 21 days. Patients were followed up for the development of ventilator-associated pneumonia, diagnosed using the Centers for Disease Control and Prevention criteria.
Main outcome measures: Incidence of ventilator-associated pneumonia, duration of hospital stay, duration of intensive care unit stay, mortality, and characteristics of organisms isolated.
Results: Fourty-one children received 1% chlorhexidine, whereas 45 received placebo application. Patients of both groups were comparable with respect to baseline characteristics. Incidence of ventilator-associated pneumonia was 39.6/1,000 ventilator days with 1% chlorhexidine and 38.1/1,000 ventilator days with placebo (relative risk 1.03, confidence interval 0.44-2.42, p = .46). The duration of intensive care unit stay and hospital stay was a mean of 8.4 ± 5.8 vs. 9.6 ± 11.4 days (p = .58) and 16.1 ± 10.2 days vs. 15.1 ± 14.3 days (p = .19) with chlorhexidine and placebo, respectively. The mortality rates were similar in the two groups (p = .81). All but two isolates causing ventilator-associated pneumonia were gram-negative, with Acinetobacter species being the most common (14 of 26). No side effects of the applied gel were seen in either group.
Conclusion: Oral mucosal application on 1% chlorhexidine gel did not prevent the development of ventilator-associated pneumonia in children 3 months to 15 yrs age.
Trial registration: ClinicalTrials.gov NCT00597688.