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Trial registered on ANZCTR


Registration number
ACTRN12609000530224
Ethics application status
Approved
Date submitted
28/06/2009
Date registered
2/07/2009
Date last updated
10/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validating Anaesthesia Simulation-based
Error Research (the VASER study).
Scientific title
Comparison of outcomes in a clinical trial evaluating a multimodal integrated drug administration system during anaesthesia to a trial in simulated patients with the same hypotheses and endpoints
Secondary ID [1] 283741 0
Nil
Universal Trial Number (UTN)
Trial acronym
VASER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whether simulation - based research provides results that can be extrapolated to clinical settings 237109 0
Condition category
Condition code
Anaesthesiology 237437 237437 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary intervention is the use of a high fidelity human patient simulator to study a clinical question.

In this SIMULATOR BASED study the intervention is that used in a previous clinical study (ACTRN12608000068369), the Safer Sleep System. This is a multimodal integrated system for the safe administration of drugs and compilation of an accurate automated record during anaesthesia.
This Systemis multifaceted and includes
novel equipment, consumables and procedures.
It was designed on the basis of lessons from empirical incident reporting, the psychological mechanisms underlying human error and the principles of system safety developed in the high-risk chemical, nuclear and aviation industries. It includes specialised trays (which support aseptic technique and promote a wellorganised
anaesthetic workspace), colour- and
bar-coded labelling of syringes (which facilitate the selection and tracking of drugs), pre-filled syringes for the most commonly used anaesthetic drugs (to remove a key error-prone step in drug administration and to save time),
and automatic visual and auditory verification of syringes using a computer and bar-codes just prior to each drug administration. The System
also compiles an automated anaesthetic record, with the intention of improving
comprehensiveness and accuracy, and of freeing the anaesthetist to spend more time caring for and monitoring the patient.
Intervention code [1] 236829 0
Other interventions
Intervention code [2] 236830 0
Prevention
Comparator / control treatment
The comparator of primary interest is the previous similar trial undertaken in patients: ACTRN12608000068369. In this SIMULATOR BASED TRIAL The comparator studied will be conventional means of anaesthesia. In this arm no barcoding or prefilled syringes will be used, participants will make a record with pen and paper, and will use standard ampoules of drugs.
Control group
Active

Outcomes
Primary outcome [1] 238235 0
This will be a binary: the acceptance or rejection of the primary research hypothesis. Accepting or rejecting the hypothesis will depend on
The rate of errors in intravenous (iv) drug administration and recording, assessed by observation and reconciliation of records with ampoule used and information obtained at debreifing.
Timepoint [1] 238235 0
Throughout the anaesthetics, which will last between 30 minutes and two hours.
Primary outcome [2] 238236 0
The overall conclusions of the simulator based study will be comared with those fo theprior clinical study.
Timepoint [2] 238236 0
Throughout the anaesthetic
Secondary outcome [1] 244567 0
Actual drug error of any type
Timepoint [1] 244567 0
Throughout anaesthetic - continuous data (measured up to every 30 seconds)
Secondary outcome [2] 244601 0
Potential harm from anaesthetics assessed with severity assessment score
Timepoint [2] 244601 0
Throughout anaesthetic - continuous data (measured up to every 30 seconds)
Secondary outcome [3] 244602 0
Potential harm from anaesthetics assessed with severity assessment score
Timepoint [3] 244602 0
Throughout anaesthetic - continuous data (measured up to every 30 seconds)
Secondary outcome [4] 244603 0
Time taken for record keeping, assessed by observation
Timepoint [4] 244603 0
Throughout anaesthetic - continuous data (measured up to every 30 seconds
Secondary outcome [5] 244604 0
Completeness of anaesthetic record assessed against a checklist
Timepoint [5] 244604 0
At end of anaesthetic
Secondary outcome [6] 244605 0
Accuracy of physiological data in the manual anaesthetic records compared with simulataneosly recorded automated records
Timepoint [6] 244605 0
At end of anaesthetic
Secondary outcome [7] 244606 0
Tracking by radiofrequency identification devices (RFIDs).
Timepoint [7] 244606 0
Throughout anaesthetics which will last from 30 minutes to 2 hours
Secondary outcome [8] 244607 0
Vigilance assessed by mean response time and rate of lapses
Timepoint [8] 244607 0
Throughout the anaesthetics, which will last from 30 minutes to 2 hours
Secondary outcome [9] 244608 0
Workload intensity measured by observation
Timepoint [9] 244608 0
Throughout the anaesthetics which will last from 30 minutes to 2 hours

Eligibility
Key inclusion criteria
No patients are involved in this trial
Minimum age
N/A
Maximum age
N/A
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This is not a trial of patients. Anaesthetists will participate using simulated patients

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participating anaesthetist will undertake two anaesthetics randomised between Safer Sleep and conventional methods of anaesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers taking into account time of day as well as method of anaesthesia
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
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] 1858 0
New Zealand
State/province [1] 1858 0
Auckland
Country [2] 1859 0
United Kingdom
State/province [2] 1859 0
Cambridge
Nottingham

Funding & Sponsors
Funding source category [1] 237220 0
Other
Name [1] 237220 0
Australian and New Zealand College of Anaesthetists
Address [1] 237220 0
630 St Kilda Rd
Melbourne
Victoria 3004
Country [1] 237220 0
Australia
Primary sponsor type
Individual
Name
Alan Merry
Address
University of AucklandPrivate Bag 92019,
Auckland,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 4712 0
None
Name [1] 4712 0
Address [1] 4712 0
Country [1] 4712 0
Other collaborator category [1] 729 0
Individual
Name [1] 729 0
Dan Wheeler
Address [1] 729 0
Department
of Anaesthetics, University of Cambridge, Box 93, Addenbrooke?s
Hospital, Hills Road, Cambridge CB2 0QQ, United Kingdom.
Country [1] 729 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239318 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 239318 0
PO Box 1031
Hamilton

(No postcode suppled by ethics committee)
Ethics committee country [1] 239318 0
New Zealand
Date submitted for ethics approval [1] 239318 0
Approval date [1] 239318 0
12/02/2009
Ethics approval number [1] 239318 0

Summary
Brief summary
The VASER study aims to validate anaesthetic simulation in error research by comaring the outcomes of this study using simulation witih those of a completed study using real patients.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29807 0
Prof Alan Merry
Address 29807 0
Department of Anaesthesiology, University of Auckland, Private Bag 92019, Auckland, New Zealand
Country 29807 0
New Zealand
Phone 29807 0
+6421492297
Fax 29807 0
Email 29807 0
a.merry@auckland.ac.nz
Contact person for public queries
Name 13054 0
Prof Alan Merry
Address 13054 0
Professor and Head of Department, Department of Anaesthesiology,
University of Auckland,
Private Bag 92019,
Auckland
New Zealand
Country 13054 0
New Zealand
Phone 13054 0
64 9 3737599 89300
Fax 13054 0
64 9 373970
Email 13054 0
a.merry@auckland.ac.nz
Contact person for scientific queries
Name 3982 0
Prof Alan Merry
Address 3982 0
Professor and HOD, Department of Anaesthesiology,
University of Auckland,
Private Bag 92019,
Auckland,
New Zealand
Country 3982 0
New Zealand
Phone 3982 0
64 9 3737599 89300
Fax 3982 0
64 9 373970
Email 3982 0
a.merry@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