Contaminated Medical or Biological SubstancesNCT03359148
Potential Risk for Bacterial Contamination in Ventilator Systems
An observational study of Contaminated Medical or Biological Substances and Environmental-Pollution-Related Condition, run by Chang Gung University.
Trial summary
Background: Few studies have investigated the difference of bacterial contamination between conventional reused ventilator systems and disposable closed ventilator-suction systems. Read more about this study
- Who is it for?
- Ages 20 to 91 years
- Conditions the study is for
- Contaminated Medical or Biological Substances, Environmental-Pollution-Related Condition
- What is being tested?
- Disposable ventilator system and Conventional reused ventilator system
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2015to 31 Jul 2016
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- the mechanically ventilated patients in the ICU
Who cannot join
- the sputum culture results of the patients indicated the presence of drug-resistant bacteria, influenza virus, and early extubation.
About this study
Official title: Potential Risk for Bacterial Contamination in Conventional Reused Ventilator Systems and Disposable Closed Ventilator-Suction Systems
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.
Read more
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.
Read the 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.
- Being tested
- Disposable ventilator system, Conventional reused ventilator system
- Keywords
- Nosocomial infection, Ventilator system, Closed suction system, Open suction system, Bacterial contamination
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable ventilator systemDevice
Conventional reused ventilator systemDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional reused ventilator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial concentration
comparison of the two ventilator systems
Measured: 7 days later
Secondary outcomes (1)
bacterial detection rate
comparison of the two ventilator systems
Measured: 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start2 Apr 2015
- Primary completion1 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contaminated Medical or Biological SubstancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Gwo-Hwa Wan, Chang Gung University
- Investigators
- GWO-HWA WAN, Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359148
- Sponsor's protocol ID
- CMRPD1D0251
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29547638
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Risk for Bacterial Contamination in Conventional Reused Ventilator Systems and Disposable Closed Ventilator-Suction Systems
- ClinicalTrials.gov ID
- NCT03359148
- Acronym / sponsor ID
- CMRPD1D0251
- Keywords
- Nosocomial infection, Ventilator system, Closed suction system, Open suction system, Bacterial contamination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disposable ventilator system | – | Device: Disposable ventilator systemThe 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. |
| Conventional reused ventilator system | – | Device: Conventional reused ventilator systemAccording 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. |
Who may qualify
- Ages
- 20 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- the mechanically ventilated patients in the ICU
Key exclusion criteria (1 listed)
- the sputum culture results of the patients indicated the presence of drug-resistant bacteria, influenza virus, and early extubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable ventilator system | Device | Disposable ventilator system |
| Conventional reused ventilator system | Device | Conventional reused ventilator system |
Primary outcome
bacterial concentration
Time frame: 7 days later
comparison of the two ventilator systems
1 secondary outcome
bacterial detection rate
Time frame: 7 days later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Derived from this study: PubMed 29547638Li 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GWO-HWA WAN, Ph.D. principal investigator
Chang Gung University
Questions about this trial
What is this clinical trial studying?
An observational study of Contaminated Medical or Biological Substances and Environmental-Pollution-Related Condition, run by Chang Gung University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial concentration (time frame: 7 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.