Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000442404
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of emergency department UltraSound-Guided peripheral intravenous catheter insertion training with Virtual Reality: a pilot Randomised Control Trial
Scientific title
Feasibility of emergency department UltraSound-Guided peripheral intravenous catheter insertion training with Virtual Reality: a pilot Randomised Control Trial in hospital medical staff
Secondary ID [1] 314283 0
None
Universal Trial Number (UTN)
Trial acronym
USG-VR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral intravenous catheter insertion 337226 0
Condition category
Condition code
Emergency medicine 333633 333633 0 0
Other emergency care
Public Health 333634 333634 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-group parallel pilot randomised controlled trial (RCT) will be conducted in Queensland. Appropriate 30 participants will be recruited (15 in the control arm, 15 in the intervention arm). All participants will receive standard ultrasound guided peripheral intravenous catheter (USG-PIVC) training. Participants in the intervention group will receive a virtual reality headset to practice needle tracking following the standard training. This practice is simulated using the VR USGIVA 1.0 System (VitaSim, Odense, Denmark), with a focus on catheter tip tracking under ultrasound guidance. The frequency of headset use is self-directed, based on each participant’s individual needs, over a two-month period in the hospital. Adherence to the intervention will be self-reported through a participant survey.
Intervention code [1] 330895 0
Treatment: Devices
Comparator / control treatment
Control arm- Participants will receive standard ultrasound guided peripheral intravenous catheter training. It includes self-directed learning of the theory on USG-PIVC insertion, along with a two-hour hands-on workshop on USG-PIVC practice, led by a qualified physician experienced in USG-PIVC training.
Control group
Active

Outcomes
Primary outcome [1] 341209 0
The composite primary outcome is feasibility. The feasibility of a fully powered trial will be determined based on the percentage of participants provided consent (more than 80%), complete the training (more than 80%), withdraw from the study (less than 5%), adhere to protocol (more than 80%), participant satisfaction (more than 80% on a 10-point scale) and acceptability (more than 80% scored more than 4 on a 5-point scale, or more than 15 over the total score of 4 items).
Timepoint [1] 341209 0
Upon conclusion of the study (after all participants have completed PIVC training)
Primary outcome [2] 341210 0
The proportion of participants achieving first attempt success in patients who are identified as difficult intravenous access.
Timepoint [2] 341210 0
At the time of insertion.
Secondary outcome [1] 446781 0
Number of failed insertion
Timepoint [1] 446781 0
At the time of insertion.
Secondary outcome [2] 446783 0
Time required for successful insertion
Timepoint [2] 446783 0
At the time of insertion.
Secondary outcome [3] 446784 0
Level of vein difficulty
Timepoint [3] 446784 0
At the time of insertion.
Secondary outcome [4] 446785 0
Completion of procedural steps
Timepoint [4] 446785 0
At the time of insertion.
Secondary outcome [5] 446786 0
Immediate complications
Timepoint [5] 446786 0
At the time of insertion.
Secondary outcome [6] 446787 0
Practiced time
Timepoint [6] 446787 0
Upon conclusion of the study (after all participants have completed PIVC training)
Secondary outcome [7] 446788 0
Confidence level of participants
Timepoint [7] 446788 0
Upon conclusion of the study (after all participants have completed PIVC training)
Secondary outcome [8] 446789 0
Satisfaction of participant
Timepoint [8] 446789 0
Upon conclusion of the study (after all participants have completed PIVC training)
Secondary outcome [9] 446790 0
Acceptability, usefulness, and feasibility of the training. This will be assessed as a composite outcome
Timepoint [9] 446790 0
Upon conclusion of the study (after all participants have completed PIVC training)

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they are employed in the participanting hospital, but did not receive any previous ultrasound guided peripheral intravenous catheter training.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are not medical staff, or agency or external staff, or have received ultrasound guided peripheral intravenous catheter training previously.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained via RedCap until as close as possible to the end of the workshop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be block randomised via a RedCap with varied block sizes at 1:1 ratio of control to intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Twenty participants will be recruited into this pilot study. Descriptive analysis will include counts and percentages for categorical data and means/standard deviation or median/interquartile range for continuous data depending on its distribution. Primary outcomes will be evaluated using t-test. Complications will be analysed using chi-square test. Data will be presented using 95% confidence intervals and p-value.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27816 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 44010 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 318800 0
Charities/Societies/Foundations
Name [1] 318800 0
PA Research Foundation
Country [1] 318800 0
Australia
Primary sponsor type
Government body
Name
Metro South Healthcare Service
Address
Country
Australia
Secondary sponsor category [1] 321245 0
None
Name [1] 321245 0
Address [1] 321245 0
Country [1] 321245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317408 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317408 0
Ethics committee country [1] 317408 0
Australia
Date submitted for ethics approval [1] 317408 0
05/03/2025
Approval date [1] 317408 0
09/04/2025
Ethics approval number [1] 317408 0
HREC/2025/QMS/116680

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140970 0
Dr Grace Xu
Address 140970 0
Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
Country 140970 0
Australia
Phone 140970 0
+61 7 31824584
Fax 140970 0
Email 140970 0
[email protected]
Contact person for public queries
Name 140971 0
Dr Grace Xu
Address 140971 0
Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
Country 140971 0
Australia
Phone 140971 0
+61 7 31824584
Fax 140971 0
Email 140971 0
[email protected]
Contact person for scientific queries
Name 140972 0
Dr Grace Xu
Address 140972 0
Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
Country 140972 0
Australia
Phone 140972 0
+61 7 31824584
Fax 140972 0
Email 140972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.