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Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Primary Purpose

Ventilator Associated Pneumonia

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Chlorhexidine gel

Placebo gel

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia

Eligibility Criteria

3 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Chlorhexidine gel

Placebo gel

Outcomes

Primary Outcome Measures

Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria

Secondary Outcome Measures

Antibiotic sensitivity of organism cultured

Duration of hospital stay

Duration of ICU stay

In hospital mortality rate

Full Information

NCT ID

NCT00597688

First Posted

January 10, 2008

Last Updated

March 22, 2011

Sponsor

All India Institute of Medical Sciences, New Delhi

1. Study Identification

Unique Protocol Identification Number

NCT00597688

Brief Title

Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator Associated Pneumonia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Chlorhexidine gel

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo gel

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine gel

Intervention Description

Oral mucosal application of chlorhexidine gel

Intervention Type

Drug

Intervention Name(s)

Placebo gel

Intervention Description

Oral mucosal application of placebo gel

Primary Outcome Measure Information:

Title

Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Antibiotic sensitivity of organism cultured

Time Frame

21 days

Title

Duration of hospital stay

Time Frame

21 days

Title

Duration of ICU stay

Time Frame

21 days

Title

In hospital mortality rate

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RAKESH LODHA

Organizational Affiliation

All India Institute of Medical Sciences, New Delhi

Official's Role

Study Director

Facility Information:

Facility Name

All India Institute of Medical Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110029

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

22760426

Citation

Sebastian MR, Lodha R, Kapil A, Kabra SK. Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial. Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.

Results Reference

derived

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Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

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