Role of Oral Chlorhexidine Gel in Prevention of Ventilato... | NCT00597688

Studies
Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

NCT00597688

Sponsor

All India Institute of Medical Sciences

Status

Completed

Last Update Posted

Mar 23, 2011Estimated

Enrollment

86Actual

Phase

Phase 3

Conditions

Ventilator Associated Pneumonia

Interventions

Chlorhexidine gel
Placebo gel

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2011

Last Update Posted Date

Mar 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Chlorhexidine gel	Drug: Chlorhexidine gel
2	Placebo Comparator	Placebo gel	Drug: Placebo gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine gel	Drug	Oral mucosal application of chlorhexidine gel	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria		21 days

Secondary Outcomes

Measure	Description	Time Frame
Antibiotic sensitivity of organism cultured		21 days
Duration of hospital stay		21 days
Duration of ICU stay

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RAKESH LODHA	All India Institute of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
All India Institute of Medical Sciences		New Delhi	National Capital Territory of Delhi	110029	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22760426	Derived	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.

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia