Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Last updated: January 14, 2017
Sponsor: C. R. Bard
Overall Status: Completed

Phase

3

Condition

Pneumonia

Lung Injury

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT00148642
5003A
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if the use of a silver-coated endotracheal tube (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 18 years

  • expected to be intubated for at least 24 hours

  • able to sign Informed Consent

Exclusion

Exclusion Criteria:

  • symptoms of bronchiectasis

  • severe hemoptysis

  • history of cystic fibrosis

  • intubated > 12 hours within previous 30 days

  • pregnancy

  • participating in a competing trial

Study Design

Total Participants: 2003
Study Start date:
November 01, 2002
Estimated Completion Date:
March 31, 2006

Study Description

Nosocomial pneumonia is the leading cause of death from hospital-acquired infections.Ventilator associated pneumonia (VAP) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. Silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. Bard has developed a proprietary antimicrobial ETT, manufactured with a hydrophilic coating containing a fine dispersion of silver salts.

This study compare the incidence and time to onset of VAP in patients intubated for >=24 hours with a proprietary silver-coated ETT versus those intubated for >= 24 hours with a standard non-coated ETT.

Connect with a study center

  • University of California, San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • West Suburban Hospital

    Oak Park, Illinois 60302
    United States

    Site Not Available

  • Mayo Clinic & Foundation

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. John's Mercy Medical Center

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Audie Murphy VA Medical Center & University Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

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