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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2003 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-03-31

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.

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

silver salts coated endotracheal tube

Group Type EXPERIMENTAL

silver salts coated endotracheal tube

Intervention Type DEVICE

intubation with silver coated tube

2

uncoated endotracheal tube

Group Type PLACEBO_COMPARATOR

uncoated endotracheal tube

Intervention Type DEVICE

intubation

Interventions

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silver salts coated endotracheal tube

intubation with silver coated tube

Intervention Type DEVICE

uncoated endotracheal tube

intubation

Intervention Type DEVICE

Other Intervention Names

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Agento

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No