<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/NCT03027323</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000958</org_study_id>
    <nct_id>NCT03027323</nct_id>
  </id_info>
  <brief_title>Washington Study of AxoTrack-Guided Central Venous Cannulation</brief_title>
  <acronym>WASHCAN</acronym>
  <official_title>Washington Study of AxoTrack-Guided Central Venous Cannulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to&#xD;
      critical levels due to several possible reasons. The medical staff treating the patient will&#xD;
      need to find out the reason for your drop in blood pressure as soon as possible. When&#xD;
      treating low blood pressure, the medical staff typically performs a procedure called central&#xD;
      venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under&#xD;
      the collarbone) by inserting a needle into the vein. By doing this, the medical staff can&#xD;
      measure the pressures in the patient's veins or give medicine to the patient while they are&#xD;
      in the hospital.&#xD;
&#xD;
      The purpose of this study is to compare the time needed to complete CVC using the AxoTrack&#xD;
      device to CVC guided by landmarks on a patient's body. The investigators expect that there&#xD;
      will be a maximum of 30 patients enrolled in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central venous cannulation (CVC) is commonly performed to give volume resuscitation and&#xD;
      parenteral medications to patients with time sensitive conditions such as severe traumatic&#xD;
      injury or undifferentiated shock. CVC via the subclavian route is associated with more&#xD;
      frequent technical complications but less frequent infection or thrombosis as compared with&#xD;
      via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is&#xD;
      guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic&#xD;
      ultrasound device is associated with a lower technical failure rate (overall and on first&#xD;
      attempt), fewer punctures, faster access, and fewer mechanical complications as compared with&#xD;
      guidance by anatomical landmarks when performed via the internal jugular vein. It remains&#xD;
      unclear whether CVC guided by real-time ultrasound is associated with significantly lower&#xD;
      failure and complication rates as compared with CVC guided by landmarks when performed via&#xD;
      the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of&#xD;
      complications, number of punctures, and the time between skin penetration and the aspiration&#xD;
      of venous blood into the syringe as compared with guidance by landmarks. A limitation of&#xD;
      guidance by a traditional diagnostic ultrasound device is it that it may require an assistant&#xD;
      to perform, which may not be feasible when treating time sensitive conditions or in low&#xD;
      resource settings. In addition, most traditional ultrasound probes are not designed to image&#xD;
      the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance&#xD;
      system recently cleared for human use by the United States Food and Drug Administration. It&#xD;
      is intended to facilitate CVC by a single operator as well as to reduce complications and&#xD;
      time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates&#xD;
      imaging of the subclavian vein. It remains unclear whether CVC guided by AxoTrack reduces&#xD;
      procedure times and complication rates when compared with CVC using landmark guidance in&#xD;
      patients with undifferentiated hypotension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not funded; no participants enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 10, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to insertion of CVC into a subclavian vein</measure>
    <time_frame>0-30 minutes</time_frame>
    <description>The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>AxoTrack System guided CVC insertion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>AxoTrack System guided CVC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVC insertion guided by landmark</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Anatomical landmarks to guide CVC</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AxoTrack System</intervention_name>
    <description>The AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein.</description>
    <arm_group_label>AxoTrack System guided CVC insertion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed systolic blood pressure &lt; 90 mmHg in emergency department;&#xD;
&#xD;
          2. Aged at least 18 years; and&#xD;
&#xD;
          3. Need for CVC in emergency department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Preexisting written do not attempt resuscitation order;&#xD;
&#xD;
          2. Prisoners;&#xD;
&#xD;
          3. Pregnant;&#xD;
&#xD;
          4. ST-elevation on initial 12-lead electrocardiogram;&#xD;
&#xD;
          5. Blunt or penetrating traumatic injury;&#xD;
&#xD;
          6. Major burn;&#xD;
&#xD;
          7. Exsanguination;&#xD;
&#xD;
          8. Obese (i.e. estimated body mass index &gt; 30 kg/m2);&#xD;
&#xD;
          9. Known coagulation disorders;&#xD;
&#xD;
         10. Contraindication to CVC by subclavian route; or&#xD;
&#xD;
         11. Patients in extremis for whom placement of the device would delay emergent care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham Nichol, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Graham Nichol</investigator_full_name>
    <investigator_title>Professor, School of Medicine: General Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>undifferentiated hypotension</keyword>
  <keyword>central venous cannulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03027323
org study id: STUDY00000958
nct id: NCT03027323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to
      critical levels due to several possible reasons. The medical staff treating the patient will
      need to find out the reason for your drop in blood pressure as soon as possible. When
      treating low blood pressure, the medical staff typically performs a procedure called central
      venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under
      the collarbone) by inserting a needle into the vein. By doing this, the medical staff can
      measure the pressures in the patient's veins or give medicine to the patient while they are
      in the hospital.

      The purpose of this study is to compare the time needed to complete CVC using the AxoTrack
      device to CVC guided by landmarks on a patient's body. The investigators expect that there
      will be a maximum of 30 patients enrolled in this study.
Central venous cannulation (CVC) is commonly performed to give volume resuscitation and
      parenteral medications to patients with time sensitive conditions such as severe traumatic
      injury or undifferentiated shock. CVC via the subclavian route is associated with more
      frequent technical complications but less frequent infection or thrombosis as compared with
      via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is
      guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic
      ultrasound device is associated with a lower technical failure rate (overall and on first
      attempt), fewer punctures, faster access, and fewer mechanical complications as compared with
      guidance by anatomical landmarks when performed via the internal jugular vein. It remains
      unclear whether CVC guided by real-time ultrasound is associated with significantly lower
      failure and complication rates as compared with CVC guided by landmarks when performed via
      the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of
      complications, number of punctures, and the time between skin penetration and the aspiration
      of venous blood into the syringe as compared with guidance by landmarks. A limitation of
      guidance by a traditional diagnostic ultrasound device is it that it may require an assistant
      to perform, which may not be feasible when treating time sensitive conditions or in low
      resource settings. In addition, most traditional ultrasound probes are not designed to image
      the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance
      system recently cleared for human use by the United States Food and Drug Administration. It
      is intended to facilitate CVC by a single operator as well as to reduce complications and
      time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates
      imaging of the subclavian vein. It remains unclear whether CVC guided by AxoTrack reduces
      procedure times and complication rates when compared with CVC using landmark guidance in
      patients with undifferentiated hypotension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time to insertion of CVC into a subclavian vein
time frame: 0-30 minutes
description: The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein
arm group label: AxoTrack System guided CVC insertion
arm group type: Other
description: AxoTrack System guided CVC
arm group label: CVC insertion guided by landmark
arm group type: No Intervention
description: Anatomical landmarks to guide CVC
intervention type: Device
intervention name: AxoTrack System
description: The AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein.
arm group label: AxoTrack System guided CVC insertion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Graham Nichol, MD, MPH
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Graham Nichol
investigator title: Professor, School of Medicine: General Internal Medicine
mesh term: Hypotension
sharing ipd: No