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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Contamination
• Intervention / Treatment: Device: Silver Knight

Detailed Description

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:

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)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• mechanical ventilators in Medisive CareUnit (MICU)

Exclusion Criteria:

• Using ventilators for less than seven days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SilverKnight group; Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria	Device: 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
No Intervention: Control group; The control group uses standard ventilator circuits.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Wen-Lun Liu, MD, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Bacterial contamination; nosocomail infection; bacterial detection rate
• Other Study ID Numbers: PL-202108037M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No