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/NCT05968950</url>
    </required_header>
    <id_info>
      <org_study_id>A096602</org_study_id>
      <nct_id>NCT05968950</nct_id>
    </id_info>
    <brief_title>Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?</brief_title>
    <acronym>ULTRRA</acronym>
    <official_title>Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cambridge University Hospitals NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to see if the investigators can find a safer and quicker&#xD;
        way to localize the correct spinal level before the start of thoracic spinal surgery.&#xD;
  &#xD;
        Currently, this localization is done with the help of spinal needles and fluoroscopy. There&#xD;
        are some inherent issues with accuracy due to individual factors such as the type of&#xD;
        operating table or the body habitus.&#xD;
  &#xD;
        The investigators want to know if the use of ultrasound to count ribs and mark the&#xD;
        corresponding spinal level would be a quicker and possibly even more accurate than the use of&#xD;
        fluoroscopy.&#xD;
  &#xD;
        Participants who will be approached for this study are those that have already consented to&#xD;
        undergo thoracic spinal surgery. Once they have been consented for the study, they will&#xD;
        undergo anesthesia as per normal and positioned prone for the intended surgery.&#xD;
  &#xD;
        At this juncture, the radiographers will be setting up to perform fluoroscopy to confirm the&#xD;
        spinal level and for the surgeons to mark the skin. For the purposes of the study, the&#xD;
        investigators will use the ultrasound to count the ribs and mark the corresponding spinal&#xD;
        level.&#xD;
  &#xD;
        Participants will undergo fluoroscopy to mark the skin level as well. The investigators are&#xD;
        studying to see if the ultrasound method is just as accurate as the traditional fluoroscopy&#xD;
        method. The results will be binary and will be recorded. The study ends at this point and no&#xD;
        further participation is required from the patient.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background &amp; Rationale&#xD;
  &#xD;
        Preoperative localization using spinal needles and fluoroscopy is the conventional method of&#xD;
        performing the level check prior to the start of the surgery, with variations including the&#xD;
        insertion of radio-opaque markers utilized in some units. Spinal needles are placed either&#xD;
        over the skin or inserted directly into the body prior to taking an xray to confirm that the&#xD;
        correct spinal levels are identified. The appropriate levels are marked on the skin and the&#xD;
        incision is subsequently planned. All techniques currently used employ ionizing radiation, at&#xD;
        potentially high doses. In the investigator's experience, they find that due to the various&#xD;
        factors which include the type of operating table or frame, the body habitus of the patient&#xD;
        (in particular, greater degrees of thoracic kyphosis, and obesity), the inadequacy of the&#xD;
        xray images to cover the entire rib cage and the presence of arms tucked to the side often&#xD;
        make the localization process tedious and often leaves us with a certain degree of&#xD;
        uncertainty.&#xD;
  &#xD;
        Ultrasound has been used by various specialties, most notably by anaesthetists and pain&#xD;
        specialties to perform point of care interventions to thoracic vertebrae. Ultrasound has also&#xD;
        been used in the thoracic region to diagnose rib fractures. Counting the rib levels to&#xD;
        localize the appropriate thoracic vertebral level was devised as a progression on these&#xD;
        methods.&#xD;
  &#xD;
        By showing that the use of ultrasound to count the ribs is a quick and accurate way to&#xD;
        localize the appropriate spinal level, the need to expose patients to repeated doses of&#xD;
        radiation can be eliminated.&#xD;
  &#xD;
        The investigators hypothesize that the use of ultrasound will allow us to accurately&#xD;
        determine the appropriate spinal level prior to the start of surgery by counting the ribs.&#xD;
        This method will not only be precise, but it will also be quick, non-invasive, cheaper and&#xD;
        will limit the amount of radiation that the patient is exposed to.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Prospective, cohort</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Accuracy</measure>
      <time_frame>This binary data will be collected during surgery</time_frame>
      <description>To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Thoracic Spine Disorder</condition>
    <arm_group>
      <arm_group_label>Thoracic spine ultrasound localization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Thoracic ultrasound</intervention_name>
      <description>The use of ultrasound to count ribs in order to surface mark the corresponding spinal level</description>
      <arm_group_label>Thoracic spine ultrasound localization</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients undergoing thoracic spine surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Paediatric patients or patients who are unable to give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
      <investigator_full_name>Bolem Nagarjun</investigator_full_name>
      <investigator_title>Associate Consultant, Division of Neurosurgery, Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Diseases</mesh_term>
      <mesh_term>Aortic Dissection</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No intention to share individual data</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/NCT05968950
  org study id: A096602
  nct id: NCT05968950
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to see if the investigators can find a safer and quicker
        way to localize the correct spinal level before the start of thoracic spinal surgery.
  
        Currently, this localization is done with the help of spinal needles and fluoroscopy. There
        are some inherent issues with accuracy due to individual factors such as the type of
        operating table or the body habitus.
  
        The investigators want to know if the use of ultrasound to count ribs and mark the
        corresponding spinal level would be a quicker and possibly even more accurate than the use of
        fluoroscopy.
  
        Participants who will be approached for this study are those that have already consented to
        undergo thoracic spinal surgery. Once they have been consented for the study, they will
        undergo anesthesia as per normal and positioned prone for the intended surgery.
  
        At this juncture, the radiographers will be setting up to perform fluoroscopy to confirm the
        spinal level and for the surgeons to mark the skin. For the purposes of the study, the
        investigators will use the ultrasound to count the ribs and mark the corresponding spinal
        level.
  
        Participants will undergo fluoroscopy to mark the skin level as well. The investigators are
        studying to see if the ultrasound method is just as accurate as the traditional fluoroscopy
        method. The results will be binary and will be recorded. The study ends at this point and no
        further participation is required from the patient.
  Background & Rationale
  
        Preoperative localization using spinal needles and fluoroscopy is the conventional method of
        performing the level check prior to the start of the surgery, with variations including the
        insertion of radio-opaque markers utilized in some units. Spinal needles are placed either
        over the skin or inserted directly into the body prior to taking an xray to confirm that the
        correct spinal levels are identified. The appropriate levels are marked on the skin and the
        incision is subsequently planned. All techniques currently used employ ionizing radiation, at
        potentially high doses. In the investigator's experience, they find that due to the various
        factors which include the type of operating table or frame, the body habitus of the patient
        (in particular, greater degrees of thoracic kyphosis, and obesity), the inadequacy of the
        xray images to cover the entire rib cage and the presence of arms tucked to the side often
        make the localization process tedious and often leaves us with a certain degree of
        uncertainty.
  
        Ultrasound has been used by various specialties, most notably by anaesthetists and pain
        specialties to perform point of care interventions to thoracic vertebrae. Ultrasound has also
        been used in the thoracic region to diagnose rib fractures. Counting the rib levels to
        localize the appropriate thoracic vertebral level was devised as a progression on these
        methods.
  
        By showing that the use of ultrasound to count the ribs is a quick and accurate way to
        localize the appropriate spinal level, the need to expose patients to repeated doses of
        radiation can be eliminated.
  
        The investigators hypothesize that the use of ultrasound will allow us to accurately
        determine the appropriate spinal level prior to the start of surgery by counting the ribs.
        This method will not only be precise, but it will also be quick, non-invasive, cheaper and
        will limit the amount of radiation that the patient is exposed to.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective, cohort
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Accuracy
  time frame: This binary data will be collected during surgery
  description: To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin
  arm group label: Thoracic spine ultrasound localization
  arm group type: Experimental
  description: Single arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy
  intervention type: Device
  intervention name: Thoracic ultrasound
  description: The use of ultrasound to count ribs in order to surface mark the corresponding spinal level
  arm group label: Thoracic spine ultrasound localization
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
  investigator full name: Bolem Nagarjun
  investigator title: Associate Consultant, Division of Neurosurgery, Principal Investigator
  mesh term: Spinal Diseases
  mesh term: Aortic Dissection
  sharing ipd: No
  ipd description: No intention to share individual data