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Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597688
First Posted: January 18, 2008
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
All India Institute of Medical Sciences, New Delhi
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Antibiotic sensitivity of organism cultured [ Time Frame: 21 days ]
  • Duration of hospital stay [ Time Frame: 21 days ]
  • Duration of ICU stay [ Time Frame: 21 days ]
  • In hospital mortality rate [ Time Frame: 21 days ]

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

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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 10, 2008
First Posted: January 18, 2008
Last Update Posted: March 23, 2011
Last Verified: February 2009

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
Disinfectants
Dermatologic Agents