Potential Risk for Bacterial Contamination in Ventilator Systems

Environmental-Pollution-Related Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359148
• Other study ID #: CMRPD1D0251
• Status: Completed
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 30, 2017
• Start date: April 2, 2015
• Est. completion date: July 31, 2016

Study information

• Verified date: November 2017
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 31, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 91 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contaminated Medical or Biological Substances
• Environmental-Pollution-Related Condition

Intervention

Device:
• Disposable ventilator system

• Conventional reused ventilator system

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University	Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial concentration	comparison of the two ventilator systems	7 days later
Secondary	bacterial detection rate	comparison of the two ventilator systems	7 days later