Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00597688

Enrollment

Registered

2008-01-18

Start date

2007-11-30

Completion date

2009-04-30

Last updated

2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Brief summary

The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Detailed description

Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Interventions

DRUGChlorhexidine gel

Oral mucosal application of chlorhexidine gel

DRUGPlacebo gel

Oral mucosal application of placebo gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Months to 15 Years

Healthy volunteers

Inclusion criteria

1. Patients in PICU requiring mechanical ventilation 2. Above the age of 3 months 3. Oro or nasotracheal intubation

Exclusion criteria

1. Known hypersensitivity to chlorhexidine 2. Inability to access the oral cavity for any reason 3. Patients with tracheostomy 4. Mechanical ventilation for more than 24 hours prior to PICU admission. 5. Death or extubation within 24 hours of ICU admission.

Design outcomes

Primary

Measure	Time frame
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria	21 days

Secondary

Measure	Time frame
Antibiotic sensitivity of organism cultured	21 days
Duration of hospital stay	21 days
Duration of ICU stay	21 days
In hospital mortality rate	21 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026