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

Fu Jen Catholic University

Status: Completed

Conditions: Bacterial Contamination

Treatments: Device: Silver Knight

Study type: Interventional

Funder types: Other

Identifiers

NCT04927806

PL-202108037M

Details and patient eligibility

About

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

Full 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)

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• mechanical ventilators in Medisive CareUnit (MICU)

Exclusion criteria

• Using ventilators for less than seven days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

SilverKnight group

Experimental group

Description:

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

Treatment:

Device: Silver Knight

Control group

No Intervention group

Description:

The control group uses standard ventilator circuits.