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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,003
intubation with silver coated tube
intubation
University of California, San Diego
San Diego, California, United States
West Suburban Hospital
Oak Park, Illinois, United States
Mayo Clinic & Foundation
Rochester, Minnesota, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.
Time frame: 30 days
time to onset of mVAP in subjects intubated for >=24 hours
Time frame: 30 days
incidence of clinical VAP in subjects intubed for >=24 hours
Time frame: 30 days
duration of intubation
Time frame: unlimited
mortality
Time frame: unlimited
antibiotic usage
Time frame: unlimited
length of stay
Time frame: unlimited
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Audie Murphy VA Medical Center & University Hospital
San Antonio, Texas, United States