<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/NCT04454801</url>
  </required_header>
  <id_info>
    <org_study_id>19-6238</org_study_id>
    <nct_id>NCT04454801</nct_id>
  </id_info>
  <brief_title>Expert Behaviors USGRA</brief_title>
  <official_title>Expert Behaviors in Ultrasound Guided Regional Anesthesia A Mixed-Methods Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Expert-performance begins by focusing specifically on the end-product of training and&#xD;
      experience in the hands of the expert. By defining expert behaviors and techniques,&#xD;
      investigators can guide learners and non-expert practitioners by offering them models to&#xD;
      emulate. At Toronto Western Hospital (TWH), there are more than ten expert attending regional&#xD;
      anesthesiologists who routinely provide clinical patient care in the block room. The primary&#xD;
      objective of this study is to qualitatively and quantitatively examine behavior of experts&#xD;
      performing ultrasound guided regional anesthesia techniques to identify those which are&#xD;
      consistent and unique, and which may underpin expert performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion</measure>
    <time_frame>1 hour before procedure</time_frame>
    <description>Reviewers will identify behaviors exhibited by the expert operators during pre-procedural discussion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative behaviors of experts performing UGRA techniques during patient and equipment preparation</measure>
    <time_frame>0.5 hour before procedure</time_frame>
    <description>Reviewers will identify behaviors exhibited by the expert operators during patient and equipment preparation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative behaviours of experts performing UGRA techniques during ultrasound scanning of the target area;</measure>
    <time_frame>10 minutes before procedure</time_frame>
    <description>Reviewers will identify behaviors exhibited by the expert operators during ultrasound scanning of the target area;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative behaviours of experts performing UGRA techniques during needle advancement and local anesthetic deposition around the target nerve(s)</measure>
    <time_frame>during procedure</time_frame>
    <description>Reviewers will identify behaviors exhibited by the expert operators during needle advancement and local anesthetic deposition around the target nerve(s).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data on block effectiveness defined by blocks requiring top-up</measure>
    <time_frame>0-1 hour after procedure</time_frame>
    <description>number of top-up will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data on block effectiveness defined by blocks requiring conversion to GA</measure>
    <time_frame>0-1 hour after procedure</time_frame>
    <description>Incidence will be documented in case conversion to GA is needed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data on time to surgical anesthesia</measure>
    <time_frame>0-1 hour after procedure</time_frame>
    <description>defined by final needle removal to surgical anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative data on time to block completion</measure>
    <time_frame>0-1 hour after procedure</time_frame>
    <description>defined by needle insertion to final needle removal</description>
  </primary_outcome>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Anesthesia Education</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a mixed methods assessment study to be completed at TWH. We will recruit 10&#xD;
        fellowship-trained regional anesthesiology and pain medicine staff anesthesiologists to&#xD;
        perform USGRA blocks while being video-recorded. Here, we specifically define expert as a&#xD;
        staff anesthesiologist who has completed a fellowship in regional anesthesia and/or chronic&#xD;
        pain and has at least 6-years of post-fellowship clinical experience with USGRA.&#xD;
&#xD;
        Consent will also be sought from 180 patients undergoing USGRA for surgical procedures at&#xD;
        TWH to have the block completed by an expert, as previously defined, and to have the&#xD;
        procedure recorded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All elective patients coming to the regional BR at TWH aged 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to USGRA (LA allergy, patient refusal, infection at injection&#xD;
             site, etc.)&#xD;
&#xD;
          -  Inability to read or speak or comprehend English fluently&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ki Jinn Chin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rongyu (Cindy) Jin</last_name>
    <phone>416-603-5800</phone>
    <phone_ext>2016</phone_ext>
    <email>rongyu.jin@uhn.ca</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04454801
org study id: 19-6238
nct id: NCT04454801
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Expert-performance begins by focusing specifically on the end-product of training and
      experience in the hands of the expert. By defining expert behaviors and techniques,
      investigators can guide learners and non-expert practitioners by offering them models to
      emulate. At Toronto Western Hospital (TWH), there are more than ten expert attending regional
      anesthesiologists who routinely provide clinical patient care in the block room. The primary
      objective of this study is to qualitatively and quantitatively examine behavior of experts
      performing ultrasound guided regional anesthesia techniques to identify those which are
      consistent and unique, and which may underpin expert performance.
observational model: Cohort
time perspective: Prospective
measure: Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion
time frame: 1 hour before procedure
description: Reviewers will identify behaviors exhibited by the expert operators during pre-procedural discussion
measure: Qualitative behaviors of experts performing UGRA techniques during patient and equipment preparation
time frame: 0.5 hour before procedure
description: Reviewers will identify behaviors exhibited by the expert operators during patient and equipment preparation
measure: Qualitative behaviours of experts performing UGRA techniques during ultrasound scanning of the target area;
time frame: 10 minutes before procedure
description: Reviewers will identify behaviors exhibited by the expert operators during ultrasound scanning of the target area;
measure: Qualitative behaviours of experts performing UGRA techniques during needle advancement and local anesthetic deposition around the target nerve(s)
time frame: during procedure
description: Reviewers will identify behaviors exhibited by the expert operators during needle advancement and local anesthetic deposition around the target nerve(s).
measure: Quantitative data on block effectiveness defined by blocks requiring top-up
time frame: 0-1 hour after procedure
description: number of top-up will be collected
measure: Quantitative data on block effectiveness defined by blocks requiring conversion to GA
time frame: 0-1 hour after procedure
description: Incidence will be documented in case conversion to GA is needed
measure: Quantitative data on time to surgical anesthesia
time frame: 0-1 hour after procedure
description: defined by final needle removal to surgical anesthesia
measure: Quantitative data on time to block completion
time frame: 0-1 hour after procedure
description: defined by needle insertion to final needle removal
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ki Jinn Chin, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Rongyu (Cindy) Jin
phone: 416-603-5800
phone ext: 2016
email: rongyu.jin@uhn.ca
responsible party type: Sponsor