Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001154695
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
8/11/2023
Date last updated
8/11/2023
Date data sharing statement initially provided
8/11/2023
Date results provided
8/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality Insertion of Chest-drain Outcomes Research study (VICTOR)
Scientific title
A Single Centre, Randomized, Parallel-group, Pilot Study to Compare Traditional Training for Chest Drain Insertion to a Novel Immersive Virtual Reality Training Software Program
Secondary ID [1] 306141 0
Nil known
Universal Trial Number (UTN)
U1111-1273-0337
Trial acronym
VICTOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical simulation 324836 0
Medical education 324837 0
Emergency procedures 324838 0
Condition category
Condition code
Anaesthesiology 322278 322278 0 0
Anaesthetics
Public Health 328485 328485 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional group will be trained to insert chest drains using a Virtual reality (VR) training method.

The Virtual reality training software is licensed by Vantari VR. The chest drain insertion module simulates the steps of chest drain insertion in a realistic environment via a head mounted display with dual hand controllers. The steps of the procedures are shown within the environment with auditory narration of each step. There is feedback with each step to indicate if the step was completed correctly or not.
The study participants will be exposed to at least one facilitated training session using the VR training module. This is to both monitor adherence and to assist with technical aspects of the equipment. The duration of the training session is 30mins. The participants can do additional training sessions at their own discretion once the initial mandatory one session has been completed.
Assessments will be done within a month of the training session.
Intervention code [1] 322549 0
Treatment: Other
Comparator / control treatment
The control group will be trained using traditional education techniques. The teaching material from the Emergency Trauma Management (ETM) course manual will be used. This course is accredited as part of the professional development program by the Australian College of Rural and Remote Medicine.
The control group will be provided with online access to the ETM online course manual section detailing the insertion of chest drains. This section also contains two online videos proving teaching on chest drain insertion. The study participants must complete at least one read through of the text and watch both instructional videos. The participants may review the material as many times as they feel necessary. A member of the study group monitors adherence by ensures the participants have read the text and watches the instructional videos at least once. Assessments will be done within a month of the training session.
Control group
Active

Outcomes
Primary outcome [1] 330039 0
Effectiveness of education assessed by proficiency of chest drain insertion using score on standardised chest drain checklist. The standardised chest drain checklist used is "The Tool for Assessing Chest Tube Insertion Competency (TACTIC)" Shefrin AE, Khazei A, Hung GR, et al. The TACTIC: development and validation of the Tool for Assessing Chest Tube Insertion Competency. CJEM 2015;17(2):140-7. doi: 10.2310/8000.2014.141406 [published Online First: 2015/05/01]
Timepoint [1] 330039 0
Assessment will be done within one month after the allocated training is completed.
Secondary outcome [1] 404696 0
Assessment of registrar levels of confidence regarding chest drain insertion pre- and post-educational sessions.
Timepoint [1] 404696 0
This will be assessed in a pre-training survey and a post training survey. These surveys have been designed specifically for this study.

Eligibility
Key inclusion criteria
All the registrars in the Fiona Stanley & Fremantle Hospital Group Department of Anaesthesia & Pain Medicine as of 3rd August 2020.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to participate or sign consent.
Not completing the chest drain training.
Adverse reaction to virtual reality hardware.
Previous use of the VR chest drain scenario if allocated to the control group.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data obtained from the two groups were tested for normal distribution via the Kolmogorov-Smirnov Test of Normality. The data was found to be normally distributed and therefore an Unpaired T Test was performed to access any difference between the two groups.
We report median results for each Likert-type question to describe central tendency.

The pilot project will use a convenience sample of Anaesthesia registrars at FSFHG. Currently there are 51 registrars. All registrars will be approached to participate. The study is a proof of concept study. Due to the fact that virtual reality software has only recently been developed, there is to the best of our knowledge no other published data to refer to. If a difference is noted between the study groups, a power analysis will be conducted to calculate the sample size necessary in a follow up study, to confirm differences that may exist.

A validated checklist will be used to assess each candidate’s placement of a chest drain. This checklist has 20 steps, graded out of 40 points, that must be completed in order for the chest drain placement to be deemed safe & successful. The mean score of the two study groups will be compared. A difference in the mean score p value of 0.05 will be deemed significant.
A power analysis will be conducted for a subsequent study, based on the results of this pilot trial.

As there is no data for VR teaching in terms of medical procedures in anaesthesia this study will provide a baseline comparison to traditional teaching. Certainly, an increase of 20% in the mean score would be seen as significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Cohort of registrars moving to new rotations at other hospitals
Date of first participant enrolment
Anticipated
Actual
11/11/2020
Date of last participant enrolment
Anticipated
Actual
30/08/2021
Date of last data collection
Anticipated
Actual
30/08/2021
Sample size
Target
51
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21441 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 36342 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 310485 0
Other Collaborative groups
Name [1] 310485 0
Kaartdijin - South Metropolitan Health Service Innovation Centre
Country [1] 310485 0
Australia
Primary sponsor type
Individual
Name
Robert Nicholas Swart
Address
Fiona Stanley Hospital 11 Robin Warren Dr,Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 311816 0
Individual
Name [1] 311816 0
Chole Goodred
Address [1] 311816 0
Level 2, Administration Building, Fiona Stanley Hospital14 Barry Marshall Parade, MURDOCH WA 6150
Country [1] 311816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310115 0
The South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 310115 0
Ethics committee country [1] 310115 0
Australia
Date submitted for ethics approval [1] 310115 0
16/09/2020
Approval date [1] 310115 0
22/10/2020
Ethics approval number [1] 310115 0
RGS0000004336

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

Contacts
Principal investigator
Name 116526 0
Dr Robert Nicholas Swart
Address 116526 0
Fiona Stanley Hospital. 11 Robin Warren Drive, Murdoch, WA, 6150
Country 116526 0
Australia
Phone 116526 0
+61 497119754
Fax 116526 0
Email 116526 0
Robert.Swart@health.wa.gov.au
Contact person for public queries
Name 116527 0
Robert Nicholas Swart
Address 116527 0
Fiona Stanley Hospital. 11 Robin Warren Drive, Murdoch, WA, 6150
Country 116527 0
Australia
Phone 116527 0
+61 497119754
Fax 116527 0
Email 116527 0
Robert.Swart@health.wa.gov.au
Contact person for scientific queries
Name 116528 0
Robert Nicholas Swart
Address 116528 0
Fiona Stanley Hospital. 11 Robin Warren Drive, Murdoch, WA, 6150
Country 116528 0
Australia
Phone 116528 0
+61 497119754
Fax 116528 0
Email 116528 0
Robert.Swart@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The transfer of data externally was not included in the protocol or informed consent form.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14784Informed consent form    383367-(Uploaded-25-01-2022-17-17-04)-Study-related document.pdf
14785Ethical approval    383367-(Uploaded-25-01-2022-17-17-19)-Study-related document.pdf
14811Study protocol    383367-(Uploaded-25-01-2022-17-17-35)-Study-related document.pdf



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.