Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000819628
Ethics application status
Approved
Date submitted
23/07/2014
Date registered
1/08/2014
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Visuospatial ability and brachial plexus sonography performance
Scientific title
In novices without prior ultrasonography experience, does the degree of innate visuospatial ability confer an advantage in successful performance of brachial plexus sonography
Secondary ID [1] 285047 0
nil
Universal Trial Number (UTN)
U1111-1159-6392
Trial acronym
not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
visuospatial ability 292565 0
ultrasound imaging of the brachial plexus 292566 0
Condition category
Condition code
Anaesthesiology 292872 292872 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational study of adult novices with no prior exposure to ultrasonography training or teaching. Baseline testing of novices' innate visuospatial ability will be performed using validated assessment tools of visuospatial performance, including components of the Weschler Adult Intelligence Scale-IV, the Vanderberg and Kuse Mental Rotations Test, and the Thurston and Jeffrey Flexibility of Closure Test. All of these tests are desktop paper and pencil, or manipulation of wooden blocks to construct shapes, and administered by a trained neuropsychologist.
After watching a short didactic instruction 15 minute video, novices are next taken to a human volunteer and asked to perform non-invasive ultrasonography of the brachial plexus from neck to axilla. Image quality, smoothness of ultrasound scanning, and ability to obtain standardised images will be assessed using an objective scoring form by Assessors, who are experts in sonography.
The assessment of visuospatial ability and scoring of performance will take a weekend.
Intervention code [1] 289883 0
Not applicable
Comparator / control treatment
Experts in ultrasonography of the brachial plexus (those performing at least 50 cases per year) will also be administered the visuospatial assessment tools, and be asked to perform the same sonography task on the same human volunteer. Experts' performance on the task will be assessed using the same objective scoring form by the same Assessors.
Control group
Active

Outcomes
Primary outcome [1] 292742 0
Sonographic performance between novices and experts, based on objective assessment scores. This assessment form has been designed specifically for this study
Timepoint [1] 292742 0
At end of brief training in sonography
Primary outcome [2] 292743 0
Sonographic performance between novices with low and high visuospatial ability, when stratified using tests of visuospatial skill on specific domains (Weschler Adult Intelligence Scale-IV, Vanderberg and Kuse Mental Rotations, and Thurston and Jeffrey Flexibility of Closure tests)
Timepoint [2] 292743 0
at end of brief training in sonography
Secondary outcome [1] 309588 0
nil
Timepoint [1] 309588 0
nil

Eligibility
Key inclusion criteria
adult volunteers enrolled in health sciences degree in a tertiary educational institution (nursing, medicine, occupational therapy, physiotherapy, medical science)
Normal or corrected to normal visual acuity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior experience, exposure to ultrasound teaching or training
Prior musculoskeletal ultrasound of the neck or shoulder, due to potential bias arising from viewing the technique
Radiology students, due to potential bias from learning from other imaging modalities
Previous cognitive or psychological testing in the past 12 months, due to potential contamination from performing similar psychometric tests of visuospatial ability

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Endpoints are individual scores in the visuospatial tests of the different domains. Performance in the sonography task is recorded as a time taken to complete, individual item scores on the objective assessment tool, and a composite performance score. Linear mixed models will be used to model each sonographic outcome. Variables in these models include expertise and the visuospatial baseline measurements. Based on the mixed models, we will compare the sonographic performance between novices and experts , and between higher and lower visuospatial ability.
No previous study has been conducted in anaesthesia or radiology examining the visuospatial ability in ultrasound imaging. However, based on other studies in surgical laparoscopic skills and gastroenterlological endoscopy skills, novices were strongly discriminated in ability based on small sample sizes <30 participants. It is thought that in early uptake of new hand-eye coordination skills, visuospatial ability is dominant in learning. A sample size of 30 was chosen for this observational study for reasons of feasibility.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2015
Actual
28/03/2015
Date of last participant enrolment
Anticipated
Actual
28/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2766 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 8464 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 289653 0
Hospital
Name [1] 289653 0
Department of Anaesthesia, Liverpool Hospital
Country [1] 289653 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Liverpool Hospital
Address
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 288380 0
None
Name [1] 288380 0
Address [1] 288380 0
Country [1] 288380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291389 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 291389 0
Ethics committee country [1] 291389 0
Australia
Date submitted for ethics approval [1] 291389 0
20/08/2014
Approval date [1] 291389 0
16/10/2014
Ethics approval number [1] 291389 0

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

Contacts
Principal investigator
Name 50178 0
Dr Alwin Chuan
Address 50178 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 50178 0
Australia
Phone 50178 0
+61 2 9828 3173
Fax 50178 0
Email 50178 0
[email protected]
Contact person for public queries
Name 50179 0
Alwin Chuan
Address 50179 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 50179 0
Australia
Phone 50179 0
+61 2 9828 3173
Fax 50179 0
Email 50179 0
[email protected]
Contact person for scientific queries
Name 50180 0
Alwin Chuan
Address 50180 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 50180 0
Australia
Phone 50180 0
+61 2 9828 3173
Fax 50180 0
Email 50180 0
[email protected]

No information has been provided regarding IPD availability


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.