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Clinical Trials/NCT03359148
NCT03359148
Completed
Not Applicable

Potential Risk for Bacterial Contamination in Conventional Reused Ventilator Systems and Disposable Closed Ventilator-Suction Systems

Chang Gung University0 sites27 target enrollmentApril 2, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contaminated Medical or Biological Substances
Sponsor
Chang Gung University
Enrollment
27
Primary Endpoint
bacterial concentration
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Background: Few studies have investigated the difference of bacterial contamination between conventional reused ventilator systems and disposable closed ventilator-suction systems. The aim of this study was to investigate the bacterial contamination rates of the reused and disposable ventilation systems, and the association between system disconnection and bacterial contamination of ventilator systems.

Methods: The enrolled patients used a conventional reused ventilator system and a disposable closed ventilator-suction system, respectively, for a week; specimens were then collected from the ventilators' internal system to evaluate human and environmental bacterial contamination. The sputum specimens from patients were also analyzed in this study.

Results: The detection rate of bacteria in the conventional reused ventilator system was substantially higher than that in the disposable system. The inspiratory and expiratory limbs of disposable closed ventilator-suction system had higher bacterial concentrations than the conventional reused ventilator system. The bacterial concentration in the heated humidifier (HH) of the reused system was significantly higher than that in the disposable system. Positive associations existed among the bacterial concentrations at different locations in the reused and disposable ventilator systems, respectively. The predominant bacteria identified in the reused and disposable ventilator systems included Acinetobacter spp., Bacillus cereus, Elizabethkingia spp., Pseudomonas spp., and Stenotrophomonas (Xan) maltophilia.

Conclusion: Both the reused and disposable ventilation systems had high bacterial contamination rates after one week of use. Disconnection of the ventilator systems should be avoided during system operation for decreasing the risks of environmental pollution and human exposure, especially for the disposable system.

Detailed Description

The intubated and mechanically ventilated patients were enrolled from the Intensive Care Unit of Chang Gung Memorial Hospital, Taiwan. The experimental study group was assigned to a disposable ventilator system combined with an auto-filled heated humidifier (HH), a closed suction catheter, and a closed aerosol therapy procedure with a valved T-adaptor. According to clinical commonly used system, the control study group was assigned to use with conventional reused ventilator system, combined with a manually filled HH, an open suction catheter, and a conventional aerosol therapy procedure. Every patient was use above both ventilator systems.

Registry
clinicaltrials.gov
Start Date
April 2, 2015
End Date
July 31, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gwo-Hwa Wan

Professor

Chang Gung University

Eligibility Criteria

Inclusion Criteria

  • the mechanically ventilated patients in the ICU

Exclusion Criteria

  • the sputum culture results of the patients indicated the presence of drug-resistant bacteria, influenza virus, and early extubation.

Outcomes

Primary Outcomes

bacterial concentration

Time Frame: 7 days later

comparison of the two ventilator systems

Secondary Outcomes

  • bacterial detection rate(7 days later)

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