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Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00597688
First received: January 10, 2008
Last updated: March 22, 2011
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Ventilator Associated Pneumonia
 Drug: Chlorhexidine gel
Drug: Placebo gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibiotic sensitivity of organism cultured [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Duration of ICU stay [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • In hospital mortality rate [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597688

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: RAKESH LODHA All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Meghna Raju Sebastian, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00597688     History of Changes
Other Study ID Numbers: Meghna
Study First Received: January 10, 2008
Last Updated: March 22, 2011
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013