Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial

Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acinetobacter
  • Acinetobacter Infections / complications
  • Administration, Topical
  • Adolescent
  • Anti-Infective Agents, Local / administration & dosage
  • Anti-Infective Agents, Local / therapeutic use*
  • Child
  • Child, Preschool
  • Chlorhexidine / administration & dosage
  • Chlorhexidine / therapeutic use*
  • Decontamination
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Intensive Care Units, Pediatric
  • Length of Stay
  • Male
  • Mouth Mucosa / microbiology*
  • Pneumonia, Ventilator-Associated / microbiology
  • Pneumonia, Ventilator-Associated / prevention & control*
  • Respiration, Artificial / adverse effects*

Substances

  • Anti-Infective Agents, Local
  • Chlorhexidine

Associated data

  • ClinicalTrials.gov/NCT00597688