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Trial registered on ANZCTR


Registration number
ACTRN12613000040763
Ethics application status
Approved
Date submitted
14/12/2012
Date registered
14/01/2013
Date last updated
20/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the microbiological contamination of drugs administered for anaesthesia in the operating theatre
Scientific title
Does the aseptic technique of anaesthetists in the administration of intravenous drugs contribute to healthcare associated infection in the operating theatre?
Secondary ID [1] 281668 0
Nil
Universal Trial Number (UTN)
U1111-1137-8928
Trial acronym
Q-bugs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heathcare associated infection due to microbiological contamination of intravenous drugs administered during anaesthesia 287968 0
Condition category
Condition code
Anaesthesiology 288353 288353 0 0
Other anaesthesiology
Public Health 288452 288452 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no intervention for this study as it is a microbiological audit of the drugs administered during anaesthesia. We propose to incorporate a 0.2micron filter unit into the drug administration line while the patient is in the operating theatre. This involves a small change in current practice which we believe is benign. Twenty participant anaesthetists will manage up to 20 surgical cases each until 300 cases in total have been completed.
Intervention code [1] 286216 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288516 0
The detection, identification and enumeration of microorganisms from IV drugs administered during anaesthesia.
A commercial sterile 0.2micron filter unit will be incorporated into the IV line; all drugs except antibiotics and propofol (due to its pharmaceutical characteristics) will be administered through this filter unit. At the conclusion of the case the filter unit will be disconnected from the IV and removed for further analysis. In the laboratory the filter unit will be back-flushed with a test solution and the eluate examined for contamination. This method has been validated.
Timepoint [1] 288516 0
The filter unit will be inserted into the IV administration line at the beginning of the case (just after the patient is transported into theatre) and removed at the end (as the patient is revived). The laboratory testing will commence after this time.
Secondary outcome [1] 300383 0
Contamination can come from a number of sources within an OT; one potentially significant source is the airborne environment. In order to monitor this contamination a blood agar plate will be placed on top of the medication trolley and opened prior to the start of each case. At the conclusion of the case the blood agar plate will be closed and transported to the laboratory for incubation at 37oC for 48 hours. Any growth will be examined to identify the micro-organisms present. This method is consistent with our previous research.
Timepoint [1] 300383 0
The blood agar plate will be opened at the start of each surgical case (at induction) and closed at the end (as the patient is revived).
Secondary outcome [2] 300384 0
The detection and identification of microbiological contamination of syringes and needles used to prepare and administer IV drugs during anaesthesia. Syringes (with residual volume greater than 0.5mL) and needles used to prepare and administer drugs to patients during each case will be analysed. Any that are closed with a syringe cap or needle and cap by the participants will be labelled as such. Those that are uncapped will be capped by researchers. Loose needles will not be collected as it is assumed these will not be used again. The articles collected will be kept refrigerated until analysed. This method has used in previous research.
Timepoint [2] 300384 0
Syringes and needles used to prepare and administer drugs to patients during each case (from patient induction to revival) will be analysed.

Eligibility
Key inclusion criteria
Anaesthetic consultants and registrars who agree to take part in the study
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4757 0
New Zealand
State/province [1] 4757 0
Auckland District Health Board (Auckland City Hospital)

Funding & Sponsors
Funding source category [1] 286471 0
University
Name [1] 286471 0
Auckland University
Faculty of Medical and Health Sciences
School of Medicine
Address [1] 286471 0
Auckland University
Private Bag 92019
Auckland 1023
Country [1] 286471 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 285261 0
Individual
Name [1] 285261 0
Professor Alan Merry
Address [1] 285261 0
Department of Medicine, University of Auckland, 85 Park Road Grafton Auckland 1023
Country [1] 285261 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288549 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288549 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 1601
Ethics committee country [1] 288549 0
New Zealand
Date submitted for ethics approval [1] 288549 0
16/05/2013
Approval date [1] 288549 0
08/07/2013
Ethics approval number [1] 288549 0
13/NTB/80

Summary
Brief summary
This study follows on from previous research carried out in the Advanced Clinical Skills Centre simulation centre at Mercy Hospital in Auckland. 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. In the current study we aim to detect and quantify the microbiological contamination of drugs prepared and administered to patients during clinical anaesthesia in theatre. We aim to test the hypothesis that the microbiological contamination rate of IV drugs administered during anaesthesia occurs sufficiently often to be detected at least once in ten cases.
This previous body of research was a substudy of a larger study "Validating Anaesthesia Simulation-based
Error Research (the VASER study)" ACTRN12609000530224
Trial website
Trial related presentations / publications
“Anaesthetic drug administration as a potential contributor to healthcare-associated infections: a prospective simulation-based evaluation of aseptic techniques in the administration of anaesthetic drugs“[Gargiulo et al, BMJ Quality & Safety, 2012 DOI: 10.1136/bmjqs-2012-000814
].
Public notes

Contacts
Principal investigator
Name 36598 0
Mrs Derryn Gargiulo
Address 36598 0
Department of Anaesthesiology, University of Auckland, Private Bag 92019, Auckland 1023
Country 36598 0
New Zealand
Phone 36598 0
+64 9 3737599 ext 89321
Fax 36598 0
Email 36598 0
d.gargiulo@auckland.ac.nz
Contact person for public queries
Name 36599 0
Prof Alan Merry
Address 36599 0
School of Medicine, University of Auckland, Private bag 92019,
Auckland 1023
Country 36599 0
New Zealand
Phone 36599 0
+64 9 3737599 ext 89301
Fax 36599 0
Email 36599 0
a.merry@auckland.ac.nz
Contact person for scientific queries
Name 36600 0
Mrs Derryn Gargiulo
Address 36600 0
Department of Anaesthesiology, University of Auckland, Private Bag 92019, Auckland 1023
Country 36600 0
New Zealand
Phone 36600 0
+64 9 3737599 ext 89321
Fax 36600 0
Email 36600 0
d.gargiulo@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary