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

Not Applicable

Completed

• Conditions: Bacterial Contamination
• Interventions: Device: Silver Knight

• Registration Number: NCT04927806
• Lead Sponsor: Fu Jen Catholic University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2021-11-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• mechanical ventilators in Medisive CareUnit (MICU)

Exclusion Criteria

• Using ventilators for less than seven days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SilverKnight group	Silver Knight	Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria

Primary Outcome Measures

Name	Time	Method
bacterial contamination	one month	comparison of the two ventilator systems

Secondary Outcome Measures

Name	Time	Method
bacterial detection rate	one month	comparison of the two ventilator systems

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan