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A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248300
First Posted: November 3, 2005
Last Update Posted: November 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Department of Defense
Uniformed Services University of the Health Sciences
TriService Nursing Research Program
Information provided by (Responsible Party):
Virginia Commonwealth University
  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 Other: Chlorhexidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP

Resource links provided by NLM:


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 ]

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. ]

Enrollment: 156
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Chlorhexidine
    Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248300


Locations
United States, Virginia
Virginia Commonwealth University School of Nursing
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
United States Department of Defense
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

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00248300     History of Changes
Other Study ID Numbers: SToPP-IT
MDA-905-03-1-TS02, N03-006
First Submitted: November 1, 2005
First Posted: November 3, 2005
Last Update Posted: November 11, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents