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/NCT06002178</url>
    </required_header>
    <id_info>
      <org_study_id>AOP3019/2023</org_study_id>
      <nct_id>NCT06002178</nct_id>
    </id_info>
    <brief_title>Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy</brief_title>
    <official_title>Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Padova</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Padova</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>
        Tracheostomy is a commonly performed procedure in Intensive Care and its incidence tends to&#xD;
        increase over time as a consequence of the increase in chronic diseases and the average age&#xD;
        of the population accessing Intensive Care.&#xD;
  &#xD;
        Surgical open tracheostomy (ST) is the standard procedure but has a relatively high incidence&#xD;
        of peristomal infections and perioperative bleeding. Percutaneous dilatational tracheostomy&#xD;
        (PDT) was introduced in 1985 and has since become a common bedside procedure. Compared to&#xD;
        open ST, PDT has the advantages of a lower risk of wound infection, lower bleeding-related&#xD;
        mortality, shorter procedure times, and improved cost-effectiveness.&#xD;
  &#xD;
        Fiberoptic bronchoscopy is commonly used during PDT to verify the safety of direct tracheal&#xD;
        access [5]. However, bronchoscopy-guided PDT has several limitations regarding the precise&#xD;
        identification of cervical anatomical structures and the prevention of complications such as&#xD;
        vascular injury.&#xD;
  &#xD;
        Preliminary ultrasound examination of neck anatomy has numerous potential benefits, including&#xD;
        increased safety during the procedure, identification of cervical vascularization, and&#xD;
        localization of the tracheal puncture site with lower risk of complications [6-8]. Several&#xD;
        studies have shown that the use of ultrasound in a preliminary and real-time manner can&#xD;
        improve first-pass success rate and puncture accuracy, reduce procedure time, and&#xD;
        complications.&#xD;
  &#xD;
        The objective of this study is to map the arterial and venous vascular anatomy of the neck in&#xD;
        order to identify points with a lower risk of vascular injury during PDT. This helps prevent&#xD;
        bleeding during tracheostomy, which is one of the major complications associated with the&#xD;
        procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 14, 2024</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>Mapping of artery and veins of the neck in the general population</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Described as the size of veins and arteries in the neck</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Size of artery and veins of the neck in the general population</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Described as the size of veins and arteries in the neck</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Tracheostomy Complication</condition>
    <condition>Trachea</condition>
    <arm_group>
      <arm_group_label>Patients undergoing surgical procedure</arm_group_label>
      <description>The following variables will be collected: age, weight, height, gender, previous neck surgery/radiotherapy, previous tracheostomy.&#xD;
  Subsequently, through ultrasound examination, the vascular anatomy of the neck will be studied by dividing it into twelve anatomical quadrants: Four medial quadrants (thyroid membrane, cricoid membrane, and cricothyroid membrane; first tracheal ring, from the beginning of the second tracheal ring to the end of the third tracheal ring), laterally on both right and left sides of each quadrant, the lateral quadrants will be identified. An ultrasound examination with a linear probe with doppler technique will be performed for each quadrant to identify the vascular structures.&#xD;
  For each quadrant, the presence of vessels, arterial or venous nature, and their diameter will be collected.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Neck ultrasound</intervention_name>
      <description>A neck ultrasound will be performed in order to map superficial arteries and veins of the neck</description>
      <arm_group_label>Patients undergoing surgical procedure</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult patients accessing the operating room for any reason&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of eighteen years or older&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tracheostomized patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>University Hospital of Padova</name>
        <address>
          <city>Padova</city>
          <state>Veneto</state>
          <zip>35127</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alessandro De Cassai, MD</last_name>
        <phone>+390498216739</phone>
        <email>alessandro.decassai@aopd.veneto.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Padova</investigator_affiliation>
      <investigator_full_name>Alessandro De Cassai</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tracheal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06002178
  org study id: AOP3019/2023
  nct id: NCT06002178
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Tracheostomy is a commonly performed procedure in Intensive Care and its incidence tends to
        increase over time as a consequence of the increase in chronic diseases and the average age
        of the population accessing Intensive Care.
  
        Surgical open tracheostomy (ST) is the standard procedure but has a relatively high incidence
        of peristomal infections and perioperative bleeding. Percutaneous dilatational tracheostomy
        (PDT) was introduced in 1985 and has since become a common bedside procedure. Compared to
        open ST, PDT has the advantages of a lower risk of wound infection, lower bleeding-related
        mortality, shorter procedure times, and improved cost-effectiveness.
  
        Fiberoptic bronchoscopy is commonly used during PDT to verify the safety of direct tracheal
        access [5]. However, bronchoscopy-guided PDT has several limitations regarding the precise
        identification of cervical anatomical structures and the prevention of complications such as
        vascular injury.
  
        Preliminary ultrasound examination of neck anatomy has numerous potential benefits, including
        increased safety during the procedure, identification of cervical vascularization, and
        localization of the tracheal puncture site with lower risk of complications [6-8]. Several
        studies have shown that the use of ultrasound in a preliminary and real-time manner can
        improve first-pass success rate and puncture accuracy, reduce procedure time, and
        complications.
  
        The objective of this study is to map the arterial and venous vascular anatomy of the neck in
        order to identify points with a lower risk of vascular injury during PDT. This helps prevent
        bleeding during tracheostomy, which is one of the major complications associated with the
        procedure.
  observational model: Cohort
  time perspective: Prospective
  measure: Mapping of artery and veins of the neck in the general population
  time frame: through study completion, an average of 1 year
  description: Described as the size of veins and arteries in the neck
  measure: Size of artery and veins of the neck in the general population
  time frame: through study completion, an average of 1 year
  description: Described as the size of veins and arteries in the neck
  arm group label: Patients undergoing surgical procedure
  description: The following variables will be collected: age, weight, height, gender, previous neck surgery/radiotherapy, previous tracheostomy.
  Subsequently, through ultrasound examination, the vascular anatomy of the neck will be studied by dividing it into twelve anatomical quadrants: Four medial quadrants (thyroid membrane, cricoid membrane, and cricothyroid membrane; first tracheal ring, from the beginning of the second tracheal ring to the end of the third tracheal ring), laterally on both right and left sides of each quadrant, the lateral quadrants will be identified. An ultrasound examination with a linear probe with doppler technique will be performed for each quadrant to identify the vascular structures.
  For each quadrant, the presence of vessels, arterial or venous nature, and their diameter will be collected.
  intervention type: Diagnostic Test
  intervention name: Neck ultrasound
  description: A neck ultrasound will be performed in order to map superficial arteries and veins of the neck
  arm group label: Patients undergoing surgical procedure
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Padova
  investigator full name: Alessandro De Cassai
  investigator title: Principal Investigator
  mesh term: Tracheal Diseases
  sharing ipd: Undecided