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Potential Risk for Bacterial Contamination in Ventilator Systems

NCT ID: NCT03359148

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-02

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Contaminated Medical or Biological Substances Environmental-Pollution-Related Condition

Keywords

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Nosocomial infection Ventilator system Closed suction system Open suction system Bacterial contamination

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Disposable ventilator system

The experimental study group will be 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.

Disposable ventilator system

Intervention Type DEVICE

Conventional reused ventilator system

According to clinical commonly used system, the control study group will be assigned to use with conventional reused ventilator system, combined with a manually filled HH, an open suction catheter, and a conventional aerosol therapy procedure.

Conventional reused ventilator system

Intervention Type DEVICE

Interventions

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Disposable ventilator system

Intervention Type DEVICE

Conventional reused ventilator system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

91 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Gwo-Hwa Wan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GWO-HWA WAN, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

References

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Li YC, Lin HL, Liao FC, Wang SS, Chang HC, Hsu HF, Chen SH, Wan GH. Potential risk for bacterial contamination in conventional reused ventilator systems and disposable closed ventilator-suction systems. PLoS One. 2018 Mar 16;13(3):e0194246. doi: 10.1371/journal.pone.0194246. eCollection 2018.

Reference Type DERIVED
PMID: 29547638 (View on PubMed)

Other Identifiers

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CMRPD1D0251

Identifier Type: -

Identifier Source: org_study_id