NCT00248300

Brief Summary

The purpose of this study is determine if a single, early dose of chlorhexidine applied within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity and the incidence of pneumonia in trauma victims.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

November 1, 2005

Last Update Submit

November 9, 2015

Conditions

Pneumonia

Keywords

ventilator-associated pneumoniahospital acquired pneumonia

Outcome Measures

Primary Outcomes (1)

  • Oral microbial flora -- measured by semi-quantitative oral culture

    At 24, 48 and 72 hours after intubation

Secondary Outcomes (1)

  • Incidence of ventilator associated pneumonia, measured by the clinical pulmonary infection score (CPIS) and obtained on study admission, 48 and 72 hours after intubation

    At 48 and 72 hours after intubation.

Interventions

ChlorhexidineOTHER

Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • trauma victim
  • endotracheal intubation within the past 12 hours
  • mechanical ventilation

You may not qualify if:

  • diagnosis of pneumonia at the time of intubation
  • previous endotracheal tube placement in the last 48 hours
  • burn injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Grap MJ, Munro CL, Elswick RK Jr, Sessler CN, Ward KR. Duration of action of a single, early oral application of chlorhexidine on oral microbial flora in mechanically ventilated patients: a pilot study. Heart Lung. 2004 Mar-Apr;33(2):83-91. doi: 10.1016/j.hrtlng.2003.12.004.

    PMID: 15024373BACKGROUND

MeSH Terms

Conditions

PneumoniaPneumonia, Ventilator-AssociatedHealthcare-Associated Pneumonia

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mary Jo E Grap, PhD

    Virginia Commonwealth University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 3, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

US(1)