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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
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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
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Secondary ID [1]
314283
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None
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Universal Trial Number (UTN)
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Trial acronym
USG-VR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
peripheral intravenous catheter insertion
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Condition category
Condition code
Emergency medicine
333633
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0
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Other emergency care
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Public Health
333634
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330895
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of participants achieving first attempt success in patients who are identified as difficult intravenous access.
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Assessment method [1]
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The insertion success defined as visible blood at the catheter hub and a successful saline flush. This outcome will be assessed either by the Research Nurse or the assessor.
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Timepoint [1]
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At the time of insertion.
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Primary outcome [2]
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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).
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Assessment method [2]
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Study records will be audited to assess these outcomes. The percentage of satisfaction will be assessed via a likert scale. The acceptability will be assessed using a validated assessment tool (Acceptability of Intervention Measure (AIM)).
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Timepoint [2]
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Upon conclusion of the study (after all participants have completed PIVC training)
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Secondary outcome [1]
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Time required for successful insertion
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Assessment method [1]
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It is measured from the skin was prepared to the time the device was successfully inserted and needle is retracted. This outcome will be assessed either by the Research Nurse or the assessor using a stopwatch.
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Timepoint [1]
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At the time of insertion.
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Secondary outcome [2]
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Acceptability, usefulness, and feasibility of the training. This will be assessed as a composite outcome
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Assessment method [2]
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This outcome will be assessed via a participant survey, which is specifically designed for this study. The survey will use the validated assessment tools (the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM)) to measure these outcomes.
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Timepoint [2]
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Upon conclusion of the study (after all participants have completed PIVC training)
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Secondary outcome [3]
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Number of failed insertion
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Assessment method [3]
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The number of needle punctues to insert device before a successful insertion. This outcome will be assessed either by the Research Nurse or the assessor.
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Timepoint [3]
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At the time of insertion.
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Secondary outcome [4]
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Satisfaction of participant
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Assessment method [4]
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It will be measured via a 10-point Likert scale. This outcome will be assessed via a participant survey which is specially designed for this study.
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Timepoint [4]
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Upon conclusion of the study (after all participants have completed PIVC training)
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Secondary outcome [5]
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Confidence level of participants
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Assessment method [5]
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It will be measured via 5 point likert scale. This outcome will be assessed via participant survey.
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Timepoint [5]
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Upon conclusion of the study (after all participants have completed PIVC training)
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Secondary outcome [6]
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Immediate complications
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Assessment method [6]
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It refers to pain using Visual Analog Scale (VAS), haematoma and extravasation through visual inspection within 5 minutes since the insertion was performed. This outcome will be assessed either by the Research Nurse or the assessor.
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Timepoint [6]
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At the time of insertion.
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Secondary outcome [7]
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Completion of procedural steps
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Assessment method [7]
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It is assessed using a skill checklist. This outcome will be assessed either by the Research Nurse or the assessor.
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Timepoint [7]
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At the time of insertion.
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Secondary outcome [8]
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Level of vein difficulty
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Assessment method [8]
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It is assessed by the assor using a validated assessment tool (A-DIVA Scale). This outcome will be assessed either by the Research Nurse or the assessor.
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Timepoint [8]
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At the time of insertion.
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Secondary outcome [9]
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Practiced time
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Assessment method [9]
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It reffers to the amount of hours participants spent on practising insertion post attending the workshop. This outcome will be assessed via participant survey specifically designed for this study.
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Timepoint [9]
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Upon conclusion of the study (after all participants have completed PIVC training)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/05/2025
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Actual
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Date of last participant enrolment
Anticipated
1/05/2026
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Actual
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Date of last data collection
Anticipated
31/07/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queen Elizabeth II Jubilee Hospital - Coopers Plains
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Recruitment postcode(s) [1]
44010
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4108 - Coopers Plains
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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PA Research Foundation
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Address [1]
318800
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Country [1]
318800
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Australia
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Primary sponsor type
Government body
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Name
Metro South Healthcare Service
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321245
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Country [1]
321245
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317408
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
317408
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
317408
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Australia
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Date submitted for ethics approval [1]
317408
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05/03/2025
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Approval date [1]
317408
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09/04/2025
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Ethics approval number [1]
317408
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HREC/2025/QMS/116680
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Summary
Brief summary
This pilot randomized controlled trial will test whether virtual reality training can help clinicians feel more confident and successfully insert an IV on the first try using ultrasound guidance in the emergency department. The goal is to see if this training approach is practical and beneficial enough to justify a larger future study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Grace Xu
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Address
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Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
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Country
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Australia
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Phone
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+61 7 31824584
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Grace Xu
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Address
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Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
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Country
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Australia
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Phone
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+61 7 31824584
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Grace Xu
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Address
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Queen Elizabeth II Jubilee Hospital, Troughton Road, Coopers Plains, QLD, 4108
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Country
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Australia
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Phone
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+61 7 31824584
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Fax
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Email
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[email protected]
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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.
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