Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
- Conditions
- Respiratory Failure
- Registration Number
- NCT00148642
- Lead Sponsor
- C. R. Bard
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2003
- age > 18 years
- expected to be intubated for at least 24 hours
- able to sign Informed Consent
- symptoms of bronchiectasis
- severe hemoptysis
- history of cystic fibrosis
- intubated > 12 hours within previous 30 days
- pregnancy
- participating in a competing trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours. 30 days
- Secondary Outcome Measures
Name Time Method time to onset of mVAP in subjects intubated for >=24 hours 30 days mortality unlimited antibiotic usage unlimited incidence of clinical VAP in subjects intubed for >=24 hours 30 days duration of intubation unlimited length of stay unlimited
Trial Locations
- Locations (5)
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
Audie Murphy VA Medical Center & University Hospital
🇺🇸San Antonio, Texas, United States
University of California, San Diego🇺🇸San Diego, California, United States