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Sponsored by: |
C. R. Bard |
Information provided by: | C. R. Bard |
ClinicalTrials.gov Identifier: | NCT00148642 |
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.
Condition | Intervention | Phase |
Respiratory Failure |
Device: silver salts coated endotracheal tube Device: uncoated endotracheal tube |
Phase III |
MedlinePlus related topics: | Pneumonia |
ChemIDplus related topics: | Sodium chloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center Clinical Trial of the Bard Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP) |
Enrollment: | 2003 |
Study Start Date: | November 2002 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
silver salts coated endotracheal tube
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Device: silver salts coated endotracheal tube
intubation with silver coated tube
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2: Placebo Comparator
uncoated endotracheal tube
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Device: uncoated endotracheal tube
intubation
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
University of California, San Diego | |||||
San Diego, California, United States, 92103 | |||||
United States, Illinois | |||||
West Suburban Hospital | |||||
Oak Park, Illinois, United States, 60302 | |||||
United States, Minnesota | |||||
Mayo Clinic & Foundation | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, Missouri | |||||
St. John's Mercy Medical Center | |||||
St. Louis, Missouri, United States, 63141 | |||||
United States, Texas | |||||
Audie Murphy VA Medical Center & University Hospital | |||||
San Antonio, Texas, United States, 78229 |
C. R. Bard |
Principal Investigator: | Marin H Kollef, MD | Barnes Jewish Hospital, St. Louis, MO |
Responsible Party: | CR Bard, Inc ( Joan Dulin ) |
Study ID Numbers: | 5003A |
First Received: | September 6, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00148642 |
Health Authority: | United States: Food and Drug Administration |
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