The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms

Study Overview
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Brief Summary
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The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).

Detailed Description
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Background: Cross transmission via skin contact and environmental media is the main route for common outbreak of health care-associated infection which more likely to be improved or prevented by infection control program. Silver Knight uses silver ions to disrupt the normal enzymatic activities of bacteria for reducing microbial growth within, and on, the surface of the breathing systems. It functions as a safe, quick and effective catalyst to deactivate pathogenic bacteria and prevent their proliferation. However, there was no study comparing the standard ventilator circuit with Silver Knight. This study focuses on the effectiveness of antimicrobial breathing system in MDRO which including carbapenem-resistant, vancomycin-resistant and multi-drug resistant. Study Design: This is a prospective, randomized study in a single hospital in the intensive care unit. Methods: In this study, we conduct a cluster-randomized crossover, single-centre trial. There are two groups: Control group: standard ventilator circuit in odd number month. Experimental group: Silver Knight in even number month This study is expected to recruit 200 subjects. During this period, the ventilator circuits are all routinely used, only the tubing will not be discarded after use for specimen collection.And the MDRO on the surfaces of ventilator circuits will be analyzed and evaluated. Effect: We expect the antimicrobial breathing system could be more effectively than the standard ventilator circuit. The policy related to current ventilator circuit will be revised according to the results of this study. Key words: Antimicrobial Breathing system, ventilator circuits, multidrug-resistant organisms (MDRO)

Official Title
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The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms

Conditions
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Bacterial Contamination

Intervention / Treatment
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* Device: Silver Knight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mechanical ventilators in Medisive CareUnit (MICU) Exclusion Criteria: Using ventilators for less than seven days
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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In this study, we conduct a cluster-randomized crossover, multicenter trial.There are two groups: Control group: standard ventilator circuit in odd number month. Experimental group: Silver Knight in even number month
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SilverKnight group<br>Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria | Device: Silver Knight<br>* Silver Knight breathing systems are all validated for up to seven days use, and remain active, in unopened packaging, for up to five years. Silver Knight is proven to help reduce the incidence of MRSA infection and other organisms including: Staphyloccus epidermis Pseudomonas aeruginosa Klebsiella pneumoniae Acinetobacter calcoaceticus Escherichia coli<br>|
| No Intervention: Control group<br>The control group uses standard ventilator circuits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial contamination | comparison of the two ventilator systems | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial detection rate | comparison of the two ventilator systems | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial contamination, nosocomail infection, bacterial detection rate