Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Chlorhexidine gel

Group Type ACTIVE_COMPARATOR

Chlorhexidine gel

Intervention Type DRUG

Oral mucosal application of chlorhexidine gel

2

Placebo gel

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

Oral mucosal application of placebo gel

Interventions

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Chlorhexidine gel

Oral mucosal application of chlorhexidine gel

Intervention Type DRUG

Placebo gel

Oral mucosal application of placebo gel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No