Clinical trial NCT04927806: The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
Official title: The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Contamination
Keywords: Bacterial contamination
nosocomail infection
bacterial detection rate
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: PREVENTION

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)

Eligibility criteria: Inclusion Criteria:

* mechanical ventilators in Medisive CareUnit (MICU)

Exclusion Criteria:

* Using ventilators for less than seven days

Primary outcomes:
measure: bacterial contamination
timeFrame: one month
Secondary outcomes:
measure: bacterial detection rate
timeFrame: one month
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
name: Wen-Lun Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.