Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597688
• Other study ID #: Meghna
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2008
• Last updated: March 22, 2011
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Chlorhexidine gel
Oral mucosal application of chlorhexidine gel
• Placebo gel
Oral mucosal application of placebo gel

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria		21 days	No
Secondary	Antibiotic sensitivity of organism cultured		21 days	No
Secondary	Duration of hospital stay		21 days	No
Secondary	Duration of ICU stay		21 days	No
Secondary	In hospital mortality rate		21 days	No