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AnesthesiaURAISENCT05668689

URAISE: Ultrasound Regional Anaesthesia Interpretation Skill Evaluation

A study testing Preliminary testing and Psychometric main study testing (Phase 5) in people with Anesthesia, run by Imperial College Healthcare NHS Trust at 6 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Preliminary testing and Psychometric main study testing (Phase 5)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
6 sitesUnited Kingdom
Study dates
13 Feb 2022to Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites, 6 recruiting
  • Belfast Health & Social Care Trust

    Belfast, BT8 8BH

    Lloyd Turbitt, lloyd.turbitt@belfasttrust.hscni.net

    LLoyd Turbitt

    Recruiting
  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH

    Alan MacFarlane, Alan.MacFarlane@ggc.scot.nhs.uk

    Alan MacFarlane

    Recruiting
  • Guy'S and St Thomas' Nhs Foundation Trust

    London, SE1 7EH

    AMIT PAWA, amit.pawa@nhs.net

    AMIT PAWA

    Recruiting
  • Imperial College Healthcare NHS Trust

    London, W21NY

    Boyne Bellew, +442033121248, boyne.bellew@nhs.net

    Sam Haddad, +442033121248, sam.haddad@nhs.net

    Recruiting
  • Aneurin Bevan University Lhb

    Newport, NP18 3XQ

    James Bowness, james.bowness@jesus.ox.ac.uk

    James Bowness

    Recruiting
  • Southern Health & Social Care Trust

    Portadown, BT63 5QQ

    PETER MERJAVY, peter.merjavy@southerntrust.hscni.net

    PETER MARJAVY

    Recruiting

Other trials in United Kingdom

About this study

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.

Read more

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

Read the detailed description

This is a prospective, multi-centre study leading to the identification of a validated, reliable and defensible tool for assessing ultrasound-guided regional anaesthesia (UGRA) image interpretation.

This study will have 5 Phases:

Phase 1 - nerve block identification:

A panel of academic experts in regional anaesthesia will review published evidence from UGRA international guidelines. They will determine which UGRA nerve blocks are relevant to anaesthetic practice in the UK, and list the anatomical and clinical knowledge that is relevant to performing these nerve blocks.

Phase 2 - content and question generation:

A panel of experts in regional anaesthesia, recognised for their involvement in regional anaesthesia societies and publications, will review the UGRA nerve blocks and the relevant anatomical structures identified in Phase 1. The anatomical structures that must be identified on ultrasound for the safe and effective performance of these blocks will be agreed upon following panel discussion. Each structure will be categorised as either:

  • Essential
  • Desirable
  • Expert
  • Not relevant

This information will be collated by the Primary and Co-investigators to generate a pilot test of UGRA interpretation content and questions.

Phase 3 - preliminary testing:

The pilot test will be administered by local investigators via a computer-based application to 35-50 anaesthetic trainees and consultants, recruited by email and flyers sent to schools of anaesthesia across the UK. The cohorts will include an equal number of trainees and consultants of varying regional anaesthesia and clinical experience. 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, which will require the participant to write free-text responses to questions. It is important to recognise that some participants will be familiar with the CRQ format while others might be more familiar with other forms of assessment question. Participants in the pilot will therefore be provided with sample questions and answers prior to the test to familiarise themselves with the question format.

"Face validity" of the test (i.e. whether it measures what it claims to) will be assessed by asking participants to comment on ease of understanding and to identify terms that appear ambiguous. Participants will be able to comment in a text box after each item in the questionnaire. They will also be asked to comment on how they would improve the test and any relevant anatomy or clinical knowledge missing from the questions. The format of the test will be amended based on the comments.

A "Difficulty Index" for each item will be calculated by dividing the number of correct responses by the total number of responses. A higher value suggests a question is easier to answer. Any item with a difficulty index of < 50% will be considered too difficult to answer by the respondents and will be considered for removal. This will be compared to the information gathered from the panel of experts on test items (that is, whether the anatomical structure is essential, desirable, expert or not relevant to the specific ultrasound guided nerve block).

The pilot study will be used to identify how well the answers for each test item discriminate between the participant's level of ultrasound experience ("construct validity"). Differences in ultrasound interpretation skills between study groups will be analysed using statistical modelling. Items that discriminate well will be retained and those that discriminate poorly will be removed from the main test.

Reliability of the test will be improved by presenting the pilot test items in a random order to minimise the effect of cognitive fatigue diminishing performance on subsequent items. The average time taken for participants to complete each item in the pilot test will also be recorded to guide the optimal final study test length. It is important to balance the maximum number of test items whilst minimising the risk of cognitive fatigue and participant drop out. While the pilot test will necessarily have more items than the final test, pilot test participants will be asked to comment on the point at which they felt fatigued to guide this balance. It will also guide understanding of whether the level of regional anaesthesia experience affects fatiguability.

Phase 4 - testing for content validity:

To ensure all items in the assessment tool contain content that tests the domain the investigators intend to test, following the pilot the amended test will be presented to the panel of 5 experts in regional anaesthesia, who will be asked to rate the suitability of ultrasound images and questions to performance of the block. This will be on a 4-point Likert scale:

  1. = definitely not suitable
  2. = probably not suitable
  3. = probably suitable
  4. = definitely suitable The "content validity" (i.e. the extent to which a measure fairly represents a particular domain) will be derived by dividing the number of experts who rated the item as probably suitable and definitely suitable (3 and 4 on the scale) by the total number of experts. Items found to be appropriate by a sufficiently high percentage of participants will be selected.

Phase 5: psychometric main study testing The final assessment tool will be administered to an equal number of anaesthetists of varying regional anaesthesia experience. Participants will be recruited using emails and flyers sent to schools of anaesthesia across the UK. Each participant will answer a series of demographic questions, including age, gender, handedness, as well as level of training and practical experience in UGRA to account for inconsistencies in clinical exposure at different stages of training.

The exam will consist of constructed response questions (CRQs). Participants will be provided with sample questions and answers before the test to familiarise themselves with the question format. The construct validity of the tool will be tested by comparing the scores of anaesthetists with their level of experience in regional anaesthesia. The level of experience is a proxy outcome measure for their proficiency in ultrasound-guided regional anaesthesia. Differences in ultrasound interpretation skills between study groups will be analysed using statistical modelling. At the end of the assessment, there will be a short questionnaire to ascertain ease of understanding and suitability of ultrasound images to support the face validity of the test.

The "internal reliability" (i.e. the consistency of results across items in a test) of the responses will be assessed using statistical modelling. A split-test method will also be used for each participant to compare the first half of their assessment with the second half to ensure internal consistency of their item responses. The difficulty index calculated for items in the pilot study will be used to ensure a balanced set of test items, in terms of their difficulty, in the first and second halves of the test. All items will be made mandatory. The test will be administered by local investigators via a web-based application. It will have an automatic system of marking to minimise inter-marker differences. It will also be manually checked by investigators who are blinded to the level and identity of the participant.

The investigators will aim to recruit a minimum of 250 participants, each of whom will be allocated a participant number to maintain anonymity.

The results will be analysed only when recruitment has ended.

Conditions
Anesthesia
Being tested
Preliminary testing, Psychometric main study testing (Phase 5)
Keywords
regional anaesthesia, questionnaire, nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preliminary testingOther

    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.

  • 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.

Study groups in NCT05668689
Study groupRoleWhat they receive
Preliminary testing (Phase 3)OtherThe pilot test will be administered by local investigators via a computer-based application to 35-50 trainees and consultants.
Receives: Other: Preliminary testing
Psychometric main study testing (Phase 5)OtherThe 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).
Receives: Other: Psychometric main study testing (Phase 5)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start13 Feb 2022
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668689
Sponsor's protocol ID
294856
Acronym
URAISE
Status last verified
Jul 2023
First submitted
8 Dec 2022
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Preliminary testing and Psychometric main study testing (Phase 5) in people with Anesthesia, run by Imperial College Healthcare NHS Trust at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Boyne Bellew (+442033121248, boyne.bellew@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire development (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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