xml: <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/NCT05968261</url>
    </required_header>
    <id_info>
      <org_study_id>6038020</org_study_id>
      <nct_id>NCT05968261</nct_id>
    </id_info>
    <brief_title>Near Remote Method to Guide Performance of Regional Anesthesia</brief_title>
    <official_title>Implementation and Measurement of a Real-time, Near-remote Method to Operationalize Ultrasound-based Regional Anesthesia/Analgesia Procedural Techniques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Glenio Mizubuti (MD, MSc)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen's University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks')&#xD;
        have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate&#xD;
        analgesics (and, consequently, their side effects), thereby improving patient safety,&#xD;
        reducing length of hospital stay and medical costs, and improving patient satisfaction.&#xD;
        However, a major barrier to mainstream uptake of such techniques relates to training. These&#xD;
        techniques require the acquisition of new skills under expert guidance, which is often not&#xD;
        possible given the daily demands placed upon anesthesiologists. As a result, many&#xD;
        opportunities for providing regional blocks may be missed.&#xD;
  &#xD;
        The purpose of this study is to implement a new real-time 'near remote' guidance method in&#xD;
        which trainees who are to perform regional blocks can do so via tele-mentoring under expert&#xD;
        guidance. This will be done using a novel technology whereby the ultrasound image is&#xD;
        concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the&#xD;
        (near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this&#xD;
        method to perform various standard of care regional blocks, either in the perioperative or&#xD;
        emergency department settings. Participants' opinions of the novel teaching and learning&#xD;
        method will be assessed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ultrasound-guided regional anesthesia/analgesia techniques (herein referred to simply as&#xD;
        'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate,&#xD;
        the need for opiate analgesics (and, consequently, their side effects), thereby improving&#xD;
        patient safety, reducing length of hospital stay and medical costs, and improving patient&#xD;
        satisfaction. However, a major barrier to mainstream uptake of such techniques relates to&#xD;
        training. These techniques require the acquisition of new skills under expert guidance, which&#xD;
        is often not possible given the daily time-sensitive and competing demands placed upon&#xD;
        anesthesiologists. Furthermore, staff shortages and increasing demands caused by the COVID-19&#xD;
        pandemic have limited expert availability for one-on-one guidance even more. As a result,&#xD;
        many opportunities for providing regional analgesia may be missed or performed in the absence&#xD;
        of expert guidance.&#xD;
  &#xD;
        Currently, expert staff regional anesthesiologists would ideally be available to supervise&#xD;
        regional blocks. In clinical practice, however, if no staff regional anesthesiologist is&#xD;
        available to supervise, senior anesthesia residents (post-graduate years 3 to 5) will often&#xD;
        proceed with performing lower-risk blocks (e.g., adductor canal blocks) independently&#xD;
        provided they feel confident and comfortable with the technique. If, however, the senior&#xD;
        anesthesia resident is not comfortable with performing a higher-risk block without&#xD;
        supervision, the patient would likely then receive general anesthesia combined with a&#xD;
        multimodal analgesic regimen for perioperative pain control.&#xD;
  &#xD;
        The purpose of the current study is to implement a new real-time 'near-remote' guidance&#xD;
        method, in which trainees who are to perform regional blocks can do so via tele-mentoring&#xD;
        under expert guidance. This will be done using an ultrasound-linked iPad which is a novel&#xD;
        technology whereby the high-resolution ultrasound image is concurrently displayed on an iPad&#xD;
        screen (for the block operator/trainee) as well as on the (near remotely supervising) expert&#xD;
        mentor's smartphone. The expert mentor will either be at a distance in the same room or in an&#xD;
        adjacent room, but readily available to intervene quickly if necessary. Trainees and mentors&#xD;
        will use this method to perform various standard of care regional blocks on patients, either&#xD;
        prior to elective surgical procedures or in the emergency department in the context of trauma&#xD;
        injuries. All regional blocks will be as per standard of care, except they will be performed&#xD;
        under expert 'near-remote' guidance.&#xD;
  &#xD;
        Following the regional block performed via tele-mentored expert-guidance, both the trainee&#xD;
        and mentor will complete a questionnaire pertaining to that particular block. Questionnaires&#xD;
        will be completed electronically via Qualtrics. Block success will also be assessed (i.e.,&#xD;
        sensory block to ice within 30 min following block performance, as per standard of care) and&#xD;
        documented. Towards the end of the study, voluntary focus group sessions will be held, during&#xD;
        which trainees and mentors will have the opportunity to provide feedback regarding the newly&#xD;
        implemented teaching and learning method. Thematic analyses will then be conducted.&#xD;
  &#xD;
        Success with the current study may lay the groundwork for future research investigations to&#xD;
        examine the feasibility of guiding such blocks by more remote methods (i.e., with the expert&#xD;
        more than a few feet away).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Participant opinion</measure>
      <time_frame>Immediately following block performance</time_frame>
      <description>The investigators will assess the opinions of mentors and trainees regarding the use of 'near-remote' guidance for the performance of ultrasound-guided regional blocks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Block success</measure>
      <time_frame>Within 30 min following block performance</time_frame>
      <description>Patients' sensation to ice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Block image</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Saved ultrasound image at the end of the block procedure. Specifically, this image will be saved after completion of local anesthetic injection and before removal of the block needle for subsequent review by a blinded expert.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>Immediately postoperatively</time_frame>
      <description>Any complications associated with performed regional blocks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>Immediately postoperatively</time_frame>
      <description>Patient satisfaction with block performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of attempts</measure>
      <time_frame>Immediately following block performance</time_frame>
      <description>Number of attempts to successfully perform regional block</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant feedback</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Qualitative feedback from trainees and mentors via focus groups</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Anesthesia</condition>
    <condition>Analgesia</condition>
    <condition>Nerve Block</condition>
    <condition>Delivery of Healthcare</condition>
    <condition>Hospitals, Teaching</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Real time 'near remote' guidance of regional blocks</intervention_name>
      <description>Trainees who are to perform regional blocks will do so under expert guidance via tele-mentoring. This will be done using a novel technology consisting of a wirelessly linked iPad which will display the ultrasound image to the block operator/trainee. This image will be concurrently visualized by an expert mentor through their smartphone, who will then provide feedback/guidance in real-time to the operator/trainee.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will include: (1) mentors, i.e., staff regional anesthesiologists who are&#xD;
          experts in ultrasound-guided regional blocks; (2) trainees, i.e., PGY-3 to PGY-5 anesthesia&#xD;
          and emergency medicine residents, and emergency medicine staff physicians; and (3)&#xD;
          patients, i.e., individuals 18 years and older scheduled for surgery amenable to regional&#xD;
          blocks or presenting to the emergency department with traumatic injuries amenable to&#xD;
          regional blocks.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mentors: Staff anesthesiologists who are experts in regional blocks.&#xD;
  &#xD;
            -  Trainees: Senior (PGY3-5) residents (anesthesiology and emergency medicine), and staff&#xD;
               (emergency medicine) physicians who have already performed and are comfortable with&#xD;
               being supervised near remotely for the regional block at hand.&#xD;
  &#xD;
            -  Patients: Greater or equal to 18 years of age presenting for surgery or with traumatic&#xD;
               injuries amenable to regional blocks.&#xD;
  &#xD;
            -  All of the above: Able to read and understand English, and competent to provide&#xD;
               written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mentors: Staff anesthesiologists who are not experts in the performance/teaching of&#xD;
               regional blocks.&#xD;
  &#xD;
            -  Trainees: Junior (PGY1-2) residents (for any/all types of regional blocks), and senior&#xD;
               (PGY3-5) residents and staff physicians who are not comfortable with being supervised&#xD;
               near remotely for the regional block at hand.&#xD;
  &#xD;
            -  Patients: Less than 18 years of age.&#xD;
  &#xD;
            -  All of the above: Unable to read and understand English, and not competent to provide&#xD;
               written informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Glenio B. Mizubuti, MD, MSc, FRCPC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Queen's University. Department of Anesthesiology and Perioperative Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stephanie Chevrier, MD</last_name>
      <phone>6138090424</phone>
      <email>stephanie.chevrier@kingstonhsc.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Glenio B. Mizubuti, MD</last_name>
      <phone>(613) 548-7827</phone>
      <email>gm75@queensu.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hotel Dieu Hospital site (primary) and Kingston General Hospital site (secondary), Kingston Health Sciences Centre</name>
        <address>
          <city>Kingston</city>
          <state>Ontario</state>
          <zip>K7L 5G2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stephanie Chevrier, MD</last_name>
        <phone>(613) 548-7827</phone>
        <email>stephanie.chevrier@kingstonhsc.ca</email>
      </contact>
      <contact_backup>
        <last_name>Glenio B. Mizubuti, MD, MSc, FRCPC</last_name>
        <phone>(613) 548-7827</phone>
        <email>glenio.mizubuti@kingstonhsc.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <link>
      <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9046753/</url>
      <description>Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesia</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/32447288/</url>
      <description>Regional anesthesia training model for resource-limited settings: a prospective single-center observational study with pre-post evaluations</description>
    </link>
    <link>
      <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8991162/</url>
      <description>Application of distant live broadcast in clinical anesthesiology teaching</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/24222344/</url>
      <description>FaceTime® for teaching ultrasound-guided anesthetic procedures in remote place</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/22612411/</url>
      <description>Novel real-time feedback and integrated simulation model for teaching and evaluating ultrasound-guided regional anesthesia skills in pediatric anesthesia trainees</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Queen's University</investigator_affiliation>
      <investigator_full_name>Dr. Glenio Mizubuti (MD, MSc)</investigator_full_name>
      <investigator_title>(MD, MSc, FRCPC, Associate Professor)</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The information which will be associated (via study ID number) with each ultrasound image includes: sex, age, BMI range, surgery type and regional block type. The data will be saved directly to a secure server, and subsequently exported to SPSS for analysis. The only identifier will be the study ID number.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968261
  org study id: 6038020
  nct id: NCT05968261
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks')
        have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate
        analgesics (and, consequently, their side effects), thereby improving patient safety,
        reducing length of hospital stay and medical costs, and improving patient satisfaction.
        However, a major barrier to mainstream uptake of such techniques relates to training. These
        techniques require the acquisition of new skills under expert guidance, which is often not
        possible given the daily demands placed upon anesthesiologists. As a result, many
        opportunities for providing regional blocks may be missed.
  
        The purpose of this study is to implement a new real-time 'near remote' guidance method in
        which trainees who are to perform regional blocks can do so via tele-mentoring under expert
        guidance. This will be done using a novel technology whereby the ultrasound image is
        concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the
        (near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this
        method to perform various standard of care regional blocks, either in the perioperative or
        emergency department settings. Participants' opinions of the novel teaching and learning
        method will be assessed.
  Ultrasound-guided regional anesthesia/analgesia techniques (herein referred to simply as
        'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate,
        the need for opiate analgesics (and, consequently, their side effects), thereby improving
        patient safety, reducing length of hospital stay and medical costs, and improving patient
        satisfaction. However, a major barrier to mainstream uptake of such techniques relates to
        training. These techniques require the acquisition of new skills under expert guidance, which
        is often not possible given the daily time-sensitive and competing demands placed upon
        anesthesiologists. Furthermore, staff shortages and increasing demands caused by the COVID-19
        pandemic have limited expert availability for one-on-one guidance even more. As a result,
        many opportunities for providing regional analgesia may be missed or performed in the absence
        of expert guidance.
  
        Currently, expert staff regional anesthesiologists would ideally be available to supervise
        regional blocks. In clinical practice, however, if no staff regional anesthesiologist is
        available to supervise, senior anesthesia residents (post-graduate years 3 to 5) will often
        proceed with performing lower-risk blocks (e.g., adductor canal blocks) independently
        provided they feel confident and comfortable with the technique. If, however, the senior
        anesthesia resident is not comfortable with performing a higher-risk block without
        supervision, the patient would likely then receive general anesthesia combined with a
        multimodal analgesic regimen for perioperative pain control.
  
        The purpose of the current study is to implement a new real-time 'near-remote' guidance
        method, in which trainees who are to perform regional blocks can do so via tele-mentoring
        under expert guidance. This will be done using an ultrasound-linked iPad which is a novel
        technology whereby the high-resolution ultrasound image is concurrently displayed on an iPad
        screen (for the block operator/trainee) as well as on the (near remotely supervising) expert
        mentor's smartphone. The expert mentor will either be at a distance in the same room or in an
        adjacent room, but readily available to intervene quickly if necessary. Trainees and mentors
        will use this method to perform various standard of care regional blocks on patients, either
        prior to elective surgical procedures or in the emergency department in the context of trauma
        injuries. All regional blocks will be as per standard of care, except they will be performed
        under expert 'near-remote' guidance.
  
        Following the regional block performed via tele-mentored expert-guidance, both the trainee
        and mentor will complete a questionnaire pertaining to that particular block. Questionnaires
        will be completed electronically via Qualtrics. Block success will also be assessed (i.e.,
        sensory block to ice within 30 min following block performance, as per standard of care) and
        documented. Towards the end of the study, voluntary focus group sessions will be held, during
        which trainees and mentors will have the opportunity to provide feedback regarding the newly
        implemented teaching and learning method. Thematic analyses will then be conducted.
  
        Success with the current study may lay the groundwork for future research investigations to
        examine the feasibility of guiding such blocks by more remote methods (i.e., with the expert
        more than a few feet away).
  observational model: Other
  time perspective: Prospective
  measure: Participant opinion
  time frame: Immediately following block performance
  description: The investigators will assess the opinions of mentors and trainees regarding the use of 'near-remote' guidance for the performance of ultrasound-guided regional blocks.
  measure: Block success
  time frame: Within 30 min following block performance
  description: Patients' sensation to ice
  measure: Block image
  time frame: Through study completion, an average of 1 year
  description: Saved ultrasound image at the end of the block procedure. Specifically, this image will be saved after completion of local anesthetic injection and before removal of the block needle for subsequent review by a blinded expert.
  measure: Complications
  time frame: Immediately postoperatively
  description: Any complications associated with performed regional blocks
  measure: Patient satisfaction
  time frame: Immediately postoperatively
  description: Patient satisfaction with block performance
  measure: Number of attempts
  time frame: Immediately following block performance
  description: Number of attempts to successfully perform regional block
  measure: Participant feedback
  time frame: Through study completion, an average of 1 year
  description: Qualitative feedback from trainees and mentors via focus groups
  intervention type: Procedure
  intervention name: Real time 'near remote' guidance of regional blocks
  description: Trainees who are to perform regional blocks will do so under expert guidance via tele-mentoring. This will be done using a novel technology consisting of a wirelessly linked iPad which will display the ultrasound image to the block operator/trainee. This image will be concurrently visualized by an expert mentor through their smartphone, who will then provide feedback/guidance in real-time to the operator/trainee.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Glenio B. Mizubuti, MD, MSc, FRCPC
  role: Principal Investigator
  affiliation: Queen's University. Department of Anesthesiology and Perioperative Medicine
  last name: Stephanie Chevrier, MD
  phone: 6138090424
  email: stephanie.chevrier@kingstonhsc.ca
  last name: Glenio B. Mizubuti, MD
  phone: (613) 548-7827
  email: gm75@queensu.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9046753/
  description: Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesia
  url: https://pubmed.ncbi.nlm.nih.gov/32447288/
  description: Regional anesthesia training model for resource-limited settings: a prospective single-center observational study with pre-post evaluations
  url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8991162/
  description: Application of distant live broadcast in clinical anesthesiology teaching
  url: https://pubmed.ncbi.nlm.nih.gov/24222344/
  description: FaceTime® for teaching ultrasound-guided anesthetic procedures in remote place
  url: https://pubmed.ncbi.nlm.nih.gov/22612411/
  description: Novel real-time feedback and integrated simulation model for teaching and evaluating ultrasound-guided regional anesthesia skills in pediatric anesthesia trainees
  responsible party type: Sponsor-Investigator
  investigator affiliation: Queen's University
  investigator full name: Dr. Glenio Mizubuti (MD, MSc)
  investigator title: (MD, MSc, FRCPC, Associate Professor)
  sharing ipd: No
  ipd description: The information which will be associated (via study ID number) with each ultrasound image includes: sex, age, BMI range, surgery type and regional block type. The data will be saved directly to a secure server, and subsequently exported to SPSS for analysis. The only identifier will be the study ID number.