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

Bacterial Contamination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927806
• Other study ID #: PL-202108037M
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• mechanical ventilators in Medisive CareUnit (MICU)

Exclusion Criteria:

• Using ventilators for less than seven days

Related Conditions & MeSH terms

• Bacterial Contamination

Intervention

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

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial contamination	comparison of the two ventilator systems	one month
Secondary	bacterial detection rate	comparison of the two ventilator systems	one month