The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
NCT ID: NCT04927806
Last Updated: 2023-03-01
Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2021-11-01
2022-06-30
Brief Summary
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Detailed Description
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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:
1. Control group: standard ventilator circuit in odd number month.
2. 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)
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
1. Control group: standard ventilator circuit in odd number month.
2. Experimental group: Silver Knight in even number month
PREVENTION
NONE
Study Groups
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SilverKnight group
Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria
Silver Knight
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
Control group
The control group uses standard ventilator circuits.
No interventions assigned to this group
Interventions
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Silver Knight
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Fu Jen Catholic University
OTHER
Responsible Party
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Ke-Yun, Chao
Group leader of Respiratory Therapists
Principal Investigators
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Wen-Lun Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
Locations
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Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, , Taiwan
Countries
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References
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Zilahi G, Artigas A, Martin-Loeches I. What's new in multidrug-resistant pathogens in the ICU? Ann Intensive Care. 2016 Dec;6(1):96. doi: 10.1186/s13613-016-0199-4. Epub 2016 Oct 6.
Chao KY, Liu WL, Chen CY, Su CH, Yang SH, Huang YT. Bacterial Colonization of Silver-Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial. Clin Respir J. 2025 Mar;19(3):e70058. doi: 10.1111/crj.70058.
Other Identifiers
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PL-202108037M
Identifier Type: -
Identifier Source: org_study_id
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