Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

March 22, 2011 updated by: All India Institute of Medical Sciences, New Delhi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Chlorhexidine gel
Drug: Chlorhexidine gel
Oral mucosal application of chlorhexidine gel
Placebo Comparator: 2
Placebo gel
Drug: Placebo gel
Oral mucosal application of placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria
Time Frame: 21 days
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Study Director: RAKESH LODHA, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meghna

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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