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Apprehending micro-organisms injected during anaesthesia: the 'Zbugs' randomised controlled trial to reduce surgical site infection

Does the injection of anaesthetic drugs through a 0.2micron filter unit in the intravenous line of surgical patients reduce infection?

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001196639
Acronym
Zbugs
Enrollment
200
Registered
2014-11-13
Start date
2017-02-01
Completion date
2018-12-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study follows on from previous simulation-based research where we found bacterial growth in 13.1% (n=5/38) of empty sterile IV bags used to collect all administered medications from ten surgical scenarios. These findings were confirmed in our recently completed clinical study (data collection completed June 2014) ACTRN12613000040763. In the current study we will test the primary hypothesis that the rate of SSI will be reduced by asking anaesthetists to inject all drugs except propofol and infusions through a 0.2micron filter unit to reduce the number of micro-organisms inadvertently injected into patients' bloodstreams. Our secondary hypothesis is that the rates of all SSI are higher in Maori and Pacific than non-Maori and non-Pacific Peoples in New Zealand.

Interventions

We propose to incorporate a 0.2micron filter unit into the intravenous lines of patients undergoing anaesthesia for hip or knee replacement or cardiothoracic surgery, and a request that participant anaesthetists inject all drugs except propofol (due to its pharmaceutical characteristics) and infusions through this. The filter unit will be inserted into the patients IV administration line at the beginning of the case (just after the patient has been transported into theatre) and removed at the en

We propose to incorporate a 0.2micron filter unit into the intravenous lines of patients undergoing anaesthesia for hip or knee replacement or cardiothoracic surgery, and a request that participant anaesthetists inject all drugs except propofol (due to its pharmaceutical characteristics) and infusions through this. The filter unit will be inserted into the patients IV administration line at the beginning of the case (just after the patient has been transported into theatre) and removed at the end of the patients stay in the post anaesthesia care unit or cardiac operating room. This involves a small change in current practice which we believe is benign and was the basis for our previous study "Investigating the microbiological contamination of drugs administered for anaesthesia in the operating theatre" ACTRN12613000040763. In the current study we will recruit participating anaesthetists managing patients under their care until the required number of cases (11,000 in total) has been included.

Sponsors

the University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

The participants are anaesthetic specialists, trainees and other medical officers willing to take part in the study, who will undertake 11,000 cases (a case is defined as one patient undergoing general or regional anaesthesia on one occasion). The cases are elective or acute hip or knee arthroplasty, or elective cardiothoracic surgery under general anaesthesia with or without regional anaesthesia, or under regional anaesthesia with sedation in adult patients (i.e. 16 years of age or over). We shall attempt to include all eligible cases started during normal working hours on Mondays to Fridays when the researchers and the participant anaesthetist are both available.

Exclusion criteria

Procedures other than hip or knee arthroplasty or elective cardiac surgery will be excluded. Participating anaesthetists will be able to exclude cases if any clinical reasons to do so emerge, including any request by a patient to opt out of the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026