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Validating Anaesthesia Simulation-based Error Research (the VASER study).

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000530224
Acronym
VASER
Enrollment
20
Registered
2009-07-02
Start date
2009-05-11
Completion date
2012-12-31
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

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.

Interventions

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 b

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.

Sponsors

Alan Merry
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

No patients are involved in this trial

Exclusion criteria

This is not a trial of patients. Anaesthetists will participate using simulated patients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026