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

Sponsor
Fu Jen Catholic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04927806
Collaborator
(none)
200
1
2
8
25.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Silver Knight
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
In this study, we conduct a cluster-randomized crossover, multicenter trial. This study is expected to recruit 200 subjects.There are two groups: Control group: standard ventilator circuit in odd number month. Experimental group: Silver Knight in even number monthIn this study, we conduct a cluster-randomized crossover, multicenter trial. This study is expected to recruit 200 subjects.There are two groups:Control group: standard ventilator circuit in odd number month. Experimental group: Silver Knight in even number month
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. bacterial contamination [one month]

    comparison of the two ventilator systems

Secondary Outcome Measures

  1. bacterial detection rate [one month]

    comparison of the two ventilator systems

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • mechanical ventilators in Medisive CareUnit (MICU)
Exclusion Criteria:
  • Using ventilators for less than seven days

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fu Jen Catholic University Hospital, Fu Jen Catholic University New Taipei City Taiwan 24352

Sponsors and Collaborators

  • Fu Jen Catholic University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University
ClinicalTrials.gov Identifier:
NCT04927806
Other Study ID Numbers:
  • PL-202108037M
First Posted:
Jun 16, 2021
Last Update Posted:
Mar 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University

Study Results

No Results Posted as of Mar 7, 2022