NCT04426227

Brief Summary

Regional anaesthesia is the performance of spinal, epidural or peripheral nerve blocks to allow patients to undergo surgery awake and to provide post-operative pain relief. Anaesthetists inject local anaesthetic using specialist needles close to nerves to prevent transmission of pain. Hand-held ultrasound is often used by anaesthetists to direct these needles to the correct position i.e. close to, but not in the nerve itself. If the needle is not adequately seen using the hand-held ultrasound it may pierce the nerve causing permanent nerve damage and significant patient harm. Within the time and resource constraints of postgraduate medical training, it would be advantageous to optimise expertise acquisition of practical skills with a cheap, self-directed educational intervention. Therefore, the aim of this study is to determine whether gaze training is associated with improved performance of an ultrasound-guided needle task. The investigators hypothesise that improved gaze control will translate to better technical performance of an ultrasound-guided regional anaesthesia task.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 2, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Composite Error Score

    Objective error scoring of performance at needling task

    Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.

Secondary Outcomes (1)

  • Change in Global Rating Scale

    Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention). Each assessment will be 15 minutes in duration.

Other Outcomes (2)

  • Change in Task completion time

    Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.

  • Change in Fixation durations

    Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.

Study Arms (2)

Group Gaze

EXPERIMENTAL

The gaze-trained group will be shown a video, derived from the eye tracker, of an expert's visual control whilst performing the ultrasound task. Participants will be made aware of the target-focused gaze strategy (lengthy and stable fixations on the needling target), and the manner in which the gaze shifted from target to tools (hands, needle and transducer) in a fast, smooth fashion. They will then be advised to try to mimic the gaze strategy of the expert while undertaking the needling task as their first training task. After completion of this training task, participants will be shown their own video data, as captured by the eye tracker. Participants will be asked to comment on differences between their own video and the expert video they had previously seen. This feedback process will be replicated a further four training task attempts. Participants in this group will therefore undergo a total of five training attempts of the needling task.

Other: Gaze training

Group Discovery

ACTIVE COMPARATOR

The discovery learning group will be given no video feedback and will be instructed to perform five training attempts at the needling task without further training or feedback.

Other: Discovery learning

Interventions

A training module in gaze training for peripheral nerve blockade

Group Gaze

A phase of discovery learning guided by novice operators themselves

Group Discovery

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate Science, Technology, Engineering or Maths (STEM) students who are capable of giving informed consent

You may not qualify if:

  • Previous experience of gaze training or eye tracking software
  • Previous experience of regional anaesthesia needling tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • David W Hewson, MBBS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Hewson, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Assistant Professor

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 11, 2020

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share