Clinical trial NCT00148642: Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
Official title: Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Keywords: ventilator-associated pneumonia
nosocomial pneumonia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 2003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* expected to be intubated for at least 24 hours
* able to sign Informed Consent

Exclusion Criteria:

* symptoms of bronchiectasis
* severe hemoptysis
* history of cystic fibrosis
* intubated \> 12 hours within previous 30 days
* pregnancy
* participating in a competing trial

Primary outcomes:
measure: The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.
timeFrame: 30 days
Secondary outcomes:
measure: time to onset of mVAP in subjects intubated for >=24 hours
timeFrame: 30 days
measure: incidence of clinical VAP in subjects intubed for >=24 hours
timeFrame: 30 days
measure: duration of intubation
timeFrame: unlimited
measure: mortality
timeFrame: unlimited
measure: antibiotic usage
timeFrame: unlimited
measure: length of stay
timeFrame: unlimited
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Oak Park
country: United States
facility: West Suburban Hospital
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic & Foundation
state: Minnesota
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: San Antonio
country: United States
facility: Audie Murphy VA Medical Center & University Hospital
state: Texas
Study officials:
affiliation: Barnes Jewish Hospital, St. Louis, MO
name: Marin H Kollef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baughman RP, Spencer RE, Kleykamp BO, Rashkin MC, Douthit MM. Ventilator associated pneumonia: quality of nonbronchoscopic bronchoalveolar lavage sample affects diagnostic yield. Eur Respir J. 2000 Dec;16(6):1152-7. doi: 10.1034/j.1399-3003.2000.16f23.x.
citation: Restrepo MI, Anzueto A, Arroliga AC, Afessa B, Atkinson MJ, Ho NJ, Schinner R, Bracken RL, Kollef MH. Economic burden of ventilator-associated pneumonia based on total resource utilization. Infect Control Hosp Epidemiol. 2010 May;31(5):509-15. doi: 10.1086/651669.
citation: Kollef MH, Afessa B, Anzueto A, Veremakis C, Kerr KM, Margolis BD, Craven DE, Roberts PR, Arroliga AC, Hubmayr RD, Restrepo MI, Auger WR, Schinner R; NASCENT Investigation Group. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA. 2008 Aug 20;300(7):805-13. doi: 10.1001/jama.300.7.805.