Potential Risk for Bacterial Contamination in Ventilator Systems

Completed

• Conditions: Environmental-Pollution-Related Condition; Contaminated Medical or Biological Substances
• Interventions: Device: Conventional reused ventilator system; Device: Disposable ventilator system

• Registration Number: NCT03359148
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study Start: 2015-04-02
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-31
• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-30
• Last Update Submitted: 2017-11-30
• Study First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional reused ventilator system	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.
Disposable ventilator system	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.

Primary Outcome Measures

Name	Time	Method
bacterial concentration	7 days later	comparison of the two ventilator systems

Secondary Outcome Measures

Name	Time	Method
bacterial detection rate	7 days later	comparison of the two ventilator systems