Potential Risk for Bacterial Contamination in Ventilator Systems

NCT03359148 | Completed DMC

• 1 other identifier: CMRPD1D0251
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• bacterial concentration

  comparison of the two ventilator systems

  7 days later

Secondary Outcomes (1)

• bacterial detection rate

  7 days later

Study Arms (2)

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.

Device: Disposable 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.

Device: Conventional reused ventilator system

Interventions

Disposable ventilator system DEVICE

Disposable ventilator system

Conventional reused ventilator system DEVICE

Conventional reused ventilator system

Eligibility Criteria

• Age: 20 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 16 patients (10 men and 6 women, aged between 20 and 91 years) were included for the final analysis. Patients had been on a mechanical ventilator for 17-46 days, and had a primary diagnosis of sepsis, septic shock, cardiac arrest, pneumonia (CAP or HAP), chronic obstructive pulmonary disease, respiratory failure, acute respiratory distress syndrome, or lung contusion.

You may qualify if:

• the mechanically ventilated patients in the ICU

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung Memorial Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 29547638 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GWO-HWA WAN, Ph.D.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 2, 2017
• Study Start: April 2, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 31, 2016
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share