Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001029987
Ethics application status
Approved
Date submitted
27/09/2011
Date registered
28/09/2011
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a Checklist for Regional Anaesthesia Procedural Skills Assessment
Scientific title
Validation of a Checklist for Regional Anaesthesia Procedural Skills Assessment
Secondary ID [1] 263117 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace based assessment tool 270869 0
Condition category
Condition code
Anaesthesiology 279047 279047 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Validation of a direct observed procedural skills assessment tool for regional anaesthesia. This tool is constructed as a checklist with objective criteria for satisfactory completion of procedural tasks in the performance of a nerve block. This checklist is completed immediately after the nerve block is performed.
Intervention code [1] 269458 0
Not applicable
Comparator / control treatment
expert assessors using scripted videos versus clinical videos
Control group
Active

Outcomes
Primary outcome [1] 279699 0
validation of checklist by inter-rater comparison between expert assessors
Timepoint [1] 279699 0
immediately after procedure
Secondary outcome [1] 294253 0
nil
Timepoint [1] 294253 0
nil

Eligibility
Key inclusion criteria
All patients presenting for surgery and labour ward requiring regional anaesthesia
All anaesthesia trainees
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
incapacity, inability, and/or refusal to give informed consent for participation

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
inter-rater reliability using intraclass correlation coefficients and kappa statistic

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
3/06/2013
Date of last participant enrolment
Anticipated
Actual
29/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 269941 0
Self funded/Unfunded
Name [1] 269941 0
Nil
Country [1] 269941 0
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street
Liverpool, Sydney
NSW 2170
Country
Australia
Secondary sponsor category [1] 268939 0
None
Name [1] 268939 0
Nil
Address [1] 268939 0
Nil
Country [1] 268939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271915 0
Ethics committee address [1] 271915 0
Ethics committee country [1] 271915 0
Date submitted for ethics approval [1] 271915 0
01/10/2011
Approval date [1] 271915 0
29/06/2012
Ethics approval number [1] 271915 0

Summary
Brief summary
The primary outcome of this study is to establish construct validity and reliability of the RAPS checklist. Construct validity describes the ability of the tool to measure the criteria under assessment, and its discriminatory power to differentiate novice versus skilled proceduralists. Reliability of the tool is its ability to be reproducible between different assessors.
Trial website
Trial related presentations / publications
Chuan A et al. Design and validation of the Regional Anaesthesia Procedural Skills Assessment Tool. Anaesthesia 2015; 70(12): 1401-1411
Public notes

Contacts
Principal investigator
Name 33205 0
Dr Alwin Chuan
Address 33205 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 33205 0
Australia
Phone 33205 0
+61 407 743 668
Fax 33205 0
Email 33205 0
[email protected]
Contact person for public queries
Name 16452 0
Dr Dr Alwin Chuan
Address 16452 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 16452 0
Australia
Phone 16452 0
+61 407743668
Fax 16452 0
Email 16452 0
[email protected]
Contact person for scientific queries
Name 7380 0
Dr Dr Alwin Chuan
Address 7380 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 7380 0
Australia
Phone 7380 0
+61 407743668
Fax 7380 0
Email 7380 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.