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Trial registered on ANZCTR


Registration number
ACTRN12611001155987
Ethics application status
Approved
Date submitted
3/11/2011
Date registered
3/11/2011
Date last updated
3/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound imaging of the obstetric epidural space and validation of a training programme: A superiority randomized controlled trial of explicit versus implicit training
Scientific title
Ultrasound imaging of the obstetric epidural space and validation of a training programme in anaesthesiologists: A superiority randomized controlled trial of explicit versus implicit training
Secondary ID [1] 273317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal ultrasound teaching and learning in Anaesthesiologists 279092 0
Condition category
Condition code
Anaesthesiology 279280 279280 0 0
Anaesthetics
Public Health 279284 279284 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two spinal ultrasound workshops were conducted and supervised 1 week apart by 2 experienced spinal ultrasonographers. They had 3 months of intensive supervised training by the principle investigator (4 years experience in performing and teaching novices spinal ultrasound) prior to commencement of the study. Each workshop comprised of an explicit teaching intervention (20 minutes), practice period (40 minutes) and videorecorded assessment period(20 minutes).
Explicit teaching intervention:Prior to initiating the study we developed and trialed a standardized explicit 10-step training programme called “the 10 easy steps of performing spinal ultrasound” based on the technique described by Carvalho et al. and modifying it to avoid some of the problems commonly encountered while learning the skill, as defined by Margarido et al. Standardized explicit (didactic) spinal ultrasound training method was taught explicitly for 20 minutes via a didactic sequential step-by-step approach.This included a 10 minute narrated PowerPoint presentation and a 10 minute demonstration of the “10 easy steps of performing spinal ultrasound”.
Intervention code [1] 283668 0
Other interventions
Comparator / control treatment
Two spinal ultrasound workshops were conducted and supervised 1 week apart by 2 experienced spinal ultrasonographers. They had 3 months of intensive supervised training by the principle investigator (4 years experience in performing and teaching novices spinal ultrasound) prior to commencement of the study. Each workshop comprised of an implicit teaching intervention (20 minutes), practice period (40 minutes) and videorecorded assessment period(20 minutes).
Implicit teaching intervention: Prior to study commencement we developed a 20 minute implicit training programme of spinal ultrasound similar to the technique described by Carvalho J et al. and Margarido et al. The teaching method was finalized after consensus by the investigators, and were trailed on two trainees who did not participate in the study.The implicit teaching method taught the technique practically without verbally referring to the 10-steps.
Control group
Active

Outcomes
Primary outcome [1] 279900 0
Global Rating Scale (GRS) score:GRS consisted of a 5-point scale that used seven-item behavioural descriptors (maximum score 40), and focused on the measuring the overall performance of the trainee rather than the specifics of the manual tasks. The GRS was chosen as it has been previously validated for objectively evaluating different anaesthesia skills.
Timepoint [1] 279900 0
Timepoint: Immediately after first teaching intervention & practice session and at 1 week immediately after second teaching intervention & practice session
Secondary outcome [1] 294722 0
Task specific checklist(TCL) score: The TCL consisted of 10 prespecified items which were rated on a scale of 0-2 (where 0=task not performed, 1=poorly performed and 2=well performed) (maximum score 20). This secondary outcome objectively measured the specifics of performing the manual spinal ultrasound tasks.
Timepoint [1] 294722 0
Timepoint: Immediately after first teaching intervention & practice session and at 1 week immediately after second teaching intervention & practice session
Secondary outcome [2] 294723 0
Image quality (IQ) score: The ultrasound images in the transverse median plane were scored on a scale of 1-5, where 1= poor visibility and all structures not identifiable, 2= all structures reasonably identifiable, 3= all structures satisfactorily identifiable, 4= good visibility of all important structures, 5= very good visibility of all important structures. This secondary outcome measured the quality of the ultrasound images obtained by the anaesthetists.
Timepoint [2] 294723 0
Timepoint: Immediately after first teaching intervention & practice session and at 1 week later immediately after second teaching intervention & practice session
Secondary outcome [3] 294728 0
Intraclass correlation coefficients (ICC) were calculated to assess agreement between 2 reviewers
Timepoint [3] 294728 0
Timepoint: Immediately after first teaching intervention & practice session and at 1 week later immediately after second teaching intervention & practice session

Eligibility
Key inclusion criteria
Anaesthetists (including trainees) with no prior spinal ultrasound experience
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unavailable to attend both workshop sessions

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)
All anaesthetists in the state (Australian Capital Territory, Australia), who were eligible to participate in the study were approached for participation. Allocation concealment was achieved with opaque sequentially numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For each workshop the anaesthesiologists (novices in performing the spinal ultrasound technique) are randomized according to a computer-generated random table, teaching groups to receive standardized training via either an explicit (didactic) 10-step or an implicit (interactive) learning.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single centre (Australia) prospective, assessor-blinded (2 reviewers from international centre) randomized controlled trial
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284149 0
Self funded/Unfunded
Name [1] 284149 0
Address [1] 284149 0
Country [1] 284149 0
Primary sponsor type
Hospital
Name
Calvary Hospital, Canberra, Australian Capital Territories
Address
Corner of Belconnen Way and Haydon Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 269112 0
None
Name [1] 269112 0
Address [1] 269112 0
Country [1] 269112 0
Other collaborator category [1] 252331 0
Individual
Name [1] 252331 0
Cristian Arzola
Address [1] 252331 0
600 University Avenue Toronto, ON M5G 1X5, Canada
Country [1] 252331 0
Canada
Other collaborator category [2] 260333 0
Individual
Name [2] 260333 0
Mrinalini Balki
Address [2] 260333 0
600 University Avenue Toronto, ON M5G 1X5
Country [2] 260333 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272112 0
Human Research and Ethics Committee, Calvary Health Care, Canberra
Ethics committee address [1] 272112 0
Corner of Belconnen Way and Haydon Drive, Bruce, ACT, 2617
Ethics committee country [1] 272112 0
Australia
Date submitted for ethics approval [1] 272112 0
15/09/2009
Approval date [1] 272112 0
21/10/2009
Ethics approval number [1] 272112 0
22-2009

Summary
Brief summary
Background
Spinal ultrasound has great potential as a teaching tool for epidural insertion; however it is currently underutilized.

Purpose
The purpose of the study was to test the efficacy of a standardized training programme of spinal ultrasound and to determine the optimal teaching method.

Methods
The study was conducted as a prospective, assessor-blinded randomized controlled trial as part of 2 standardized workshops 1 week apart at a single centre in Australia during December 2010. For each workshop the anaesthesiologists (novices in performing the spinal ultrasound technique) were randomized according to a computer-generated random table, into 2 teaching groups to receive standardized training via either an explicit (didactic) 10-step or an implicit (interactive) learning method. Allocation concealment achieved with opaque sequentially numbered sealed envelopes. This was followed by a practice session and assessment of specific ultrasound tasks on pregnant volunteers. They were individually videorecorded for assessment, and subsequently rated by two experienced international blinded assessors from a using a global rating scale (GRS) and checklist. Saved lumbar intervertebral images were also rated. Main outcome measure: GRS score. Secondary outcome measures: Task specific checklist and image quality scores. ICC’s were calculated to assess agreement between reviewers.
Trial website
None
Trial related presentations / publications
Terblanche, N and Lawson, R and Blackford, D. Ultrasound imaging of the obstetric epidural space: validation of a training programme , Proceedings of the 40th Annual Meeting of the Society for Obstetric Anesthesia and Perinatology, May 12-16, San Antonio, Texas (2010) [Conference Extract]
Public notes

Contacts
Principal investigator
Name 33256 0
Address 33256 0
Country 33256 0
Phone 33256 0
Fax 33256 0
Email 33256 0
Contact person for public queries
Name 16503 0
Nico Terblanche
Address 16503 0
48 Liverpool Street
Hobart
Tasmania
7000
Country 16503 0
Australia
Phone 16503 0
+61 03 6222 7866
Fax 16503 0
+61 03 6222 7533
Email 16503 0
nico.terblanche@dhhs.tas.gov.au
Contact person for scientific queries
Name 7431 0
Nico Terblanche
Address 7431 0
48 Liverpool Street
Hobart
Tasmania
7000
Country 7431 0
Australia
Phone 7431 0
+61 03 6222 7866
Fax 7431 0
+61 03 6222 7533
Email 7431 0
nico.terblanche@dhhs.tas.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary