Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: silver salts coated endotracheal tube
* Device: uncoated endotracheal tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>silver salts coated endotracheal tube | Device: silver salts coated endotracheal tube<br>* intubation with silver coated tube<br>* Other names: Agento;|
| Placebo Comparator: 2<br>uncoated endotracheal tube | Device: uncoated endotracheal tube<br>* intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | unlimited | 
| mortality |  | unlimited | 
| antibiotic usage |  | unlimited | 
| length of stay |  | unlimited | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilator-associated pneumonia, nosocomial pneumonia