<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426227</url>
  </required_header>
  <id_info>
    <org_study_id>434-1912</org_study_id>
    <nct_id>NCT04426227</nct_id>
  </id_info>
  <brief_title>Gaze Training on Task Performance Regional Anaesthesia</brief_title>
  <official_title>The Effect of Gaze Training on Task Performance and Skill Acquisition in Ultrasound-guided Regional Anaesthesia: a Partially Blinded Randomised Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Regional anaesthesia is the performance of spinal, epidural or peripheral nerve blocks to&#xD;
      allow patients to undergo surgery awake and to provide post-operative pain relief.&#xD;
      Anaesthetists inject local anaesthetic using specialist needles close to nerves to prevent&#xD;
      transmission of pain. Hand-held ultrasound is often used by anaesthetists to direct these&#xD;
      needles to the correct position i.e. close to, but not in the nerve itself. If the needle is&#xD;
      not adequately seen using the hand-held ultrasound it may pierce the nerve causing permanent&#xD;
      nerve damage and significant patient harm.&#xD;
&#xD;
      Within the time and resource constraints of postgraduate medical training, it would be&#xD;
      advantageous to optimise expertise acquisition of practical skills with a cheap,&#xD;
      self-directed educational intervention. Therefore, the aim of this study is to determine&#xD;
      whether gaze training is associated with improved performance of an ultrasound-guided needle&#xD;
      task. The investigators hypothesise that improved gaze control will translate to better&#xD;
      technical performance of an ultrasound-guided regional anaesthesia task.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Composite Error Score</measure>
    <time_frame>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.</time_frame>
    <description>Objective error scoring of performance at needling task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Global Rating Scale</measure>
    <time_frame>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.</time_frame>
    <description>Objective performance scoring of needling task, scored from 0-35, higher scores indicating better task performance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Task completion time</measure>
    <time_frame>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.</time_frame>
    <description>Time taken to finish needling task</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Fixation durations</measure>
    <time_frame>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.</time_frame>
    <description>The total duration in seconds during the task that the participant spends engaging fixation visual behaviour in pre-defined areas of interest during the needling task</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">43</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group Gaze</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Discovery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gaze training</intervention_name>
    <description>A training module in gaze training for peripheral nerve blockade</description>
    <arm_group_label>Group Gaze</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discovery learning</intervention_name>
    <description>A phase of discovery learning guided by novice operators themselves</description>
    <arm_group_label>Group Discovery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergraduate Science, Technology, Engineering or Maths (STEM) students who are&#xD;
             capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous experience of gaze training or eye tracking software&#xD;
&#xD;
          -  Previous experience of regional anaesthesia needling tasks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David W Hewson, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David W Hewson, MBBS</last_name>
    <phone>01159249924</phone>
    <phone_ext>61195</phone_ext>
    <email>David.hewson@nottingham.ac.uk</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nottingham</investigator_affiliation>
    <investigator_full_name>David Hewson</investigator_full_name>
    <investigator_title>Honorary Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426227
org study id: 434-1912
nct id: NCT04426227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Composite Error Score
time frame: 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.
description: Objective error scoring of performance at needling task
measure: Change in Global Rating Scale
time frame: 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.
description: Objective performance scoring of needling task, scored from 0-35, higher scores indicating better task performance.
measure: Change in Task completion time
time frame: 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.
description: Time taken to finish needling task
measure: Change in Fixation durations
time frame: 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.
description: The total duration in seconds during the task that the participant spends engaging fixation visual behaviour in pre-defined areas of interest during the needling task
arm group label: Group Gaze
arm group type: Experimental
description: 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.
arm group label: Group Discovery
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Gaze training
description: A training module in gaze training for peripheral nerve blockade
arm group label: Group Gaze
intervention type: Other
intervention name: Discovery learning
description: A phase of discovery learning guided by novice operators themselves
arm group label: Group Discovery
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David W Hewson, MBBS
role: Principal Investigator
affiliation: University of Nottingham
last name: David W Hewson, MBBS
phone: 01159249924
phone ext: 61195
email: David.hewson@nottingham.ac.uk
responsible party type: Principal Investigator
investigator affiliation: University of Nottingham
investigator full name: David Hewson
investigator title: Honorary Assistant Professor
sharing ipd: No