<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/NCT02982317</url>
  </required_header>
  <id_info>
    <org_study_id>H16-02858</org_study_id>
    <nct_id>NCT02982317</nct_id>
  </id_info>
  <brief_title>Automated UltraSound Software for Identification of Lumbar Vertebral Levels</brief_title>
  <acronym>AUSSI</acronym>
  <official_title>Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A novel automated ultrasound software system has been developed which identifies for the&#xD;
      practitioner the intervertebral spaces in the lumbar area. This study aims to investigate&#xD;
      whether this new technology has a greater accuracy of identifying intervertebral spaces that&#xD;
      manual palpation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of ultrasound is one of the most accurate ways to identify the correct vertebral&#xD;
      level for needle insertion in spinal/epidural anesthetics, however this is not commonly used.&#xD;
      A novel automated ultrasound software system has been developed by the UBC Department of&#xD;
      Engineering which identifies for the practitioner the intervertebral spaces in the lumbar&#xD;
      area. This study aim to investigate whether this new technology has a greater accuracy of&#xD;
      identifying intervertebral spaces that manual palpation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Actual">June 15, 2017</completion_date>
  <primary_completion_date type="Actual">June 15, 2017</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>Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)</measure>
    <time_frame>Within 1 hour of recuitment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>All patients recruited will undergo the same protocol. An anesthesiologist will perform manual palpation of the patients lumbar spine and identification of the intervertebral spaces from L1-S1. A member of the UBC Department of Engineering will perform the US scanning and level identification using the novel US technology. In addition, freehand US will be used by two practitioners to determine the participant's lumbar level locations as per gold standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manual palpation identification lumbar spine</intervention_name>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Automated ultrasound technology identification</intervention_name>
    <description>This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar level identification gold standard ultrasound</intervention_name>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parturients scheduled for an elective Cesarean section at BC Women's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I or II&#xD;
&#xD;
          -  ≥ 19 years old&#xD;
&#xD;
          -  Term pregnancy (≥ 37 weeks gestation age)&#xD;
&#xD;
          -  Scheduled for elective Cesarean section&#xD;
&#xD;
          -  Ability to read English in order to understand the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal to participate&#xD;
&#xD;
          -  BMI ≥ 40&#xD;
&#xD;
          -  Scoliosis&#xD;
&#xD;
          -  Previous lower back surgery or known spinal abnormalities&#xD;
&#xD;
          -  Inability to palpate bony landmarks in lumbar region&#xD;
&#xD;
          -  Active labour (cervical dilatation &gt;5cm)&#xD;
&#xD;
          -  Allergy to epidural tape, surgical paper tape, or felt pen&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anton Chau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC Women's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 24, 2017</last_update_submitted>
  <last_update_submitted_qc>November 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Anton Chau</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Neuraxial anesthesia</keyword>
  <keyword>Obstetrics</keyword>
  <keyword>Ultrasound</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 22, 2022</submitted>
    <returned>February 22, 2023</returned>
    <submitted>February 27, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02982317
org study id: H16-02858
nct id: NCT02982317
lead sponsor: 
has dmc: No
A novel automated ultrasound software system has been developed which identifies for the
      practitioner the intervertebral spaces in the lumbar area. This study aims to investigate
      whether this new technology has a greater accuracy of identifying intervertebral spaces that
      manual palpation.
The use of ultrasound is one of the most accurate ways to identify the correct vertebral
      level for needle insertion in spinal/epidural anesthetics, however this is not commonly used.
      A novel automated ultrasound software system has been developed by the UBC Department of
      Engineering which identifies for the practitioner the intervertebral spaces in the lumbar
      area. This study aim to investigate whether this new technology has a greater accuracy of
      identifying intervertebral spaces that manual palpation.
observational model: Cohort
time perspective: Prospective
measure: Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)
time frame: Within 1 hour of recuitment
arm group label: Study group
description: All patients recruited will undergo the same protocol. An anesthesiologist will perform manual palpation of the patients lumbar spine and identification of the intervertebral spaces from L1-S1. A member of the UBC Department of Engineering will perform the US scanning and level identification using the novel US technology. In addition, freehand US will be used by two practitioners to determine the participant's lumbar level locations as per gold standard.
intervention type: Procedure
intervention name: Manual palpation identification lumbar spine
arm group label: Study group
intervention type: Procedure
intervention name: Automated ultrasound technology identification
description: This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine
arm group label: Study group
intervention type: Procedure
intervention name: Lumbar level identification gold standard ultrasound
arm group label: Study group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: No
last name: Anton Chau, MD
role: Principal Investigator
affiliation: Univeristy of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Anton Chau
investigator title: PI
sharing ipd: No
submitted: May 22, 2022
returned: February 22, 2023
submitted: February 27, 2023