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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | silver salts coated endotracheal tube |
|
| 2 | Placebo Comparator | uncoated endotracheal tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver salts coated endotracheal tube | Device | intubation with silver coated tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| time to onset of mVAP in subjects intubated for >=24 hours | 30 days | |
| incidence of clinical VAP in subjects intubed for >=24 hours | 30 days | |
| duration of intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marin H Kollef, MD | Barnes Jewish Hospital, St. Louis, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States | ||
| West Suburban Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11292122 | Background | 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. | |
| 20302428 | Derived | 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053717 | Pneumonia, Ventilator-Associated |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D003428 | Cross Infection |
| D007239 | Infections |
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| uncoated endotracheal tube | Device | intubation |
|
| unlimited |
| mortality | unlimited |
| antibiotic usage | unlimited |
| length of stay | unlimited |
| Oak Park |
| Illinois |
| 60302 |
| United States |
| Mayo Clinic & Foundation | Rochester | Minnesota | 55905 | United States |
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Audie Murphy VA Medical Center & University Hospital | San Antonio | Texas | 78229 | United States |
| 18714060 | Derived | 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. |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |