URAISE: Ultrasound Regional Anaesthesia Interpretation Skill Evaluation

NCT05668689 | Unknown DMC

• 1 other identifier: 294856
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

Prospective study based on psychometric principles.# To generate a validated test of ultrasound guided regional anaesthesia that can used to differentiate reliably between users of different skill levels. Primary outcome: Development of a validated, reliable and defensible tool to test ultrasound guided regional anaesthesia image interpretation skills. Secondary outcomes: Development a validated, reliable and defensible assessment tool assessing anatomical, clinical knowledge and the performance of ultrasound guided regional anaesthesia: Assessment of anatomical knowledge relevant to performing a local anaesthetic injection around peripheral nerves Assessment of clinical knowledge relevant to regional anaesthesia required to perform a local anaesthetic injection around peripheral nerves Assessment of knowledge relating to the performance of an ultrasound-guided local anaesthetic injection around peripheral nerve

Conditions

Anesthesia

Keywords

regional anaesthesia; questionnaire; nerve block

Outcome Measures

Primary Outcomes (1)

• Questionnaire development

  Develop a validated, reliable and defensible test of ultrasound guided regional anaesthesia image interpretation. The test will include constructed response questions to assess: * anatomical and clinical knowledge related to ultrasound image interpretation that is relevant to performing a local anaesthetic injection around peripheral nerves * knowledge relating to the performance of an ultrasound-guided peripheral nerve block

  18 months

Study Arms (2)

Preliminary testing (Phase 3)

OTHER

The pilot test will be administered by local investigators via a computer-based application to 35-50 trainees and consultants.

Other: Preliminary testing

Psychometric main study testing (Phase 5)

OTHER

The main study assessment tool will be administered to trainees of all levels and consultants, aiming to recruit an equal number across different stages of the RCoA curriculum and of varying regional anaesthesia experience (stage 1; stage 2; stage 3; stage 3 + regional fellowship trained; consultant; consultant with special interest in regional; consultant + regional fellowship trained).

Other: Psychometric main study testing (Phase 5)

Interventions

Preliminary testing OTHER

The pilot test will be administered by local investigators via a computer-based application to 35-50 trainees and consultants. The cohorts will include an equal number of trainees and consultants of varying experience, based on the new RCOA curriculum and the extent of their regional experience (stage 1 (CT1-3); stage 2 (ST4-5); stage 3 (ST6-7); stage 3 + regional fellowship trained; consultant; consultant with special interest in regional; consultant + regional fellowship trained). The pilot test will contain short video clips and images of ultrasound guided regional anaesthesia with questions in a constructed response question (CRQ) format to identify relevant structures, anatomy and clinical knowledge.

Preliminary testing (Phase 3)

Psychometric main study testing (Phase 5) OTHER

The main study assessment tool will be administered to trainees of all levels and consultants, aiming to recruit an equal number across different stages of the RCoA curriculum and of varying regional anaesthesia experience (stage 1; stage 2; stage 3; stage 3 + regional fellowship trained; consultant; consultant with special interest in regional; consultant + regional fellowship trained). The exam will consist of constructed response questions (CRQs), which will require the participant to write free-text responses to questions, in line with RCoA examinations.

Psychometric main study testing (Phase 5)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants registered in an approved UK anaesthetic training program OR
• Anaesthetic consultants on the GMC register

You may not qualify if:

• Not registered in an approved UK anaesthetic training program OR
• Not anaesthetic consultants on the GMC register

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (6)

Belfast Health & Social Care Trust

Belfast, BT8 8BH, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, G12 0XH, United Kingdom

RECRUITING

Guy'S and St Thomas' Nhs Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W21NY, United Kingdom

RECRUITING

Aneurin Bevan University Lhb

Newport, NP18 3XQ, United Kingdom

RECRUITING

Southern Health & Social Care Trust

Portadown, BT63 5QQ, United Kingdom

RECRUITING

Study Officials

• Boyne Bellew

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boyne Bellew

CONTACT

+442033121248; boyne.bellew@nhs.net

Sam Haddad

CONTACT

+442033121248; sam.haddad@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants Participants will complete the test online or face-face and questions for each participant will be presented in a random order - no test is the same. Participants will not know the result of the test. Investigators Each participant will be identified by a unique sequential number identifier allocated to them and this will ensure all participants will have pseudo-anonymised data. Investigators can only veiw the pseudo-anonymised results.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 Nerve block identification Phase 2 Content and question generation Phase 3 Preliminary testing Phase 4 Testing for content validity Phase 5 Psychometric main study testing

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 30, 2022
• Study Start: February 13, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

GB (6)