Skip to main content
OpenTrials
Completed

NCT Number: NCT00597688

Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

chlorhexidine gel

Drug

Oral mucosal application of chlorhexidine gel

Placebo Gel

Drug

Oral mucosal application of placebo gel

Primary outcomes

  1. Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria

    Time frame: 21 days

Secondary outcomes

  1. Antibiotic sensitivity of organism cultured

    Time frame: 21 days

  2. Duration of hospital stay

    Time frame: 21 days

  3. Duration of ICU stay

    Time frame: 21 days

  4. In hospital mortality rate

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2008
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.