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A Peri-Intubation Oral Intervention to Reduce Oral Flora and VAP
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, December 2007
Sponsors and Collaborators: Virginia Commonwealth University
Department of Defense
Uniformed Services University of the Health Sciences
TriService Nursing Research Program
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00248300
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Chlorhexidine
Phase IV

MedlinePlus related topics: Pneumonia
Drug Information available for: Chlorhexidine Chlorhexidine digluconate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: A Peri-Intubation Oral Intervention to Reduce Oral Flora and VAP

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Oral microbial flora -- measured by semi-quantitative oral culture [ Time Frame: At 24, 48 and 72 hours after intubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of ventilator associated pneumonia, measured by the clinical pulmonary infection score (CPIS) and obtained on study admission, 48 and 72 hours after intubation [ Time Frame: At 48 and 72 hours after intubation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2005
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Pneumonia is the leading cause of death from nosocomial infections. Intubation and mechanical ventilation greatly increase the risk of ventilator associated pneumonia (VAP) which is highest in trauma, burn, neurosurgical and surgical patients. Oral bacteria have been shown to be responsible for the development of VAP since the endotracheal tube provides a pathway for direct entry of bacteria from the oropharynx to the respiratory tract. Therefore, reducing the number of microorganisms in the mouth reduces the pool of organisms available for translocation to and colonization of the lung. The Tri-Service Oral Health Survey showed that military recruits had inferior oral health when compared to their civilian cohorts. Further, oral hygiene is likely to deteriorate in combat situations, increasing oral microbial flora. Intubation of combat casualties in the future will likely be performed in the field by the EMT-B trained combat medic (91W) under adverse conditions. Therefore, interventions to reduce oral microbial flora with intubation are attractive to reduce the incidence of VAP in combat casualties. This study will test the effect of a single peri-intubation oral intervention on oral microbial flora and the development of VAP in traumatic injury. Two hundred trauma patients requiring endotracheal intubation will be randomly assigned to either the intervention or control group over an 18-month data collection period. Data related to oral microbial flora (measured by semi-quantitative oral culture) and VAP (measured by the clinical pulmonary infection score-CPIS) will be obtained on study admission, at 24 (oral culture data only), 48 and 72 hours after intubation. The exact Wilcoxon two-sample one-sided test will be used to test for difference between groups. CPIS data will be compared using an analysis of covariance model. Covariates such as baseline oral culture category, trauma-injury and severity score (TRISS), illness severity (APACHE III) and frequency and timing of usual oral care will also be included. The findings from this study will be the first report of an empirically based peri-intubation oral intervention to reduce VAP and can be easily applied to the care of traumatic injury in both combat and civilian casualties.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diagnosis of pneumonia at the time of intubation
  • previous endotracheal tube placement in the last 48 hours
  • burn injuries
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248300

Contacts
Contact: Anne Hamilton, MS, FNP 804-828-3237 vahamilt@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University School of Nursing Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Uniformed Services University of the Health Sciences
TriService Nursing Research Program
Investigators
Principal Investigator: Mary Jo E Grap, PhD Virginia Commonwealth University School of Nursing
  More Information

Dr. Mary Jo Grap (PI) Virginia Commonwealth University School of Nursing webpage  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Virginia Commonwealth University ( Mary Jo Grap PhD )
Study ID Numbers: SToPP-IT, MDA-905-03-1-TS02, N03-006
Study First Received: November 1, 2005
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00248300  
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
ventilator-associated pneumonia
hospital acquired pneumonia

Study placed in the following topic categories:
Chlorhexidine
Respiratory Tract Infections
Respiratory Tract Diseases
Chlorhexidine gluconate
Lung Diseases
Pneumonia, Ventilator-Associated
Pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009