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

NCT04927806 | Completed

• 1 other identifier: PL-202108037M
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacterial Contamination

Keywords

Bacterial contamination; nosocomail infection; bacterial detection rate

Outcome Measures

Primary Outcomes (1)

• bacterial contamination

  comparison of the two ventilator systems

  one month

Secondary Outcomes (1)

• bacterial detection rate

  one month

Study Arms (2)

SilverKnight group

EXPERIMENTAL

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

Device: Silver Knight

Control group

NO INTERVENTION

The control group uses standard ventilator circuits.

Interventions

Silver Knight DEVICE

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

SilverKnight group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• mechanical ventilators in Medisive CareUnit (MICU)

You may not qualify if:

• Using ventilators for less than seven days

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 27714706 BACKGROUND

• Chao KY, Liu WL, Chen CY, Su CH, Yang SH, Huang YT. Bacterial Colonization of Silver-Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial. Clin Respir J. 2025 Mar;19(3):e70058. doi: 10.1111/crj.70058.

  PMID: 40052538 DERIVED

Study Officials

• Wen-Lun Liu, MD

  Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader of Respiratory Therapists

Model Details: In this study, we conduct a cluster-randomized crossover, multicenter trial.There are two groups: 1. Control group: standard ventilator circuit in odd number month. 2. Experimental group: Silver Knight in even number month

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)