<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/NCT03231345</url>
  </required_header>
  <id_info>
    <org_study_id>16.08.002</org_study_id>
    <nct_id>NCT03231345</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Peripheral IJ Study</brief_title>
  <official_title>Ultrasound-guided Placement of Peripheral Intravenous Lines in the Internal Jugular Vein.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center of Southern Nevada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center of Southern Nevada</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Difficult venous access in some patients such as those with obesity, IV drug use, chronic&#xD;
      illness, or vascular pathology often causes increased discomfort and delayed patient care due&#xD;
      to multiple attempts to gain venous access. If access is achieved at all, it usually results&#xD;
      in a much smaller catheter than needed to provide optimal care for the patient.&#xD;
      Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the&#xD;
      investigators' emergency department and is gaining popularity across the US. This study&#xD;
      investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in&#xD;
      the internal jugular vein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous access in the emergency department (ED) patient is essential for medication&#xD;
      delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of&#xD;
      IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic&#xD;
      illnesses, or vascular pathology may have difficult IV access. These patients are problematic&#xD;
      for the busy ED nurse and physician as this can lead to a time consuming process, which slows&#xD;
      efficiency and patient care.&#xD;
&#xD;
      Previously, patients with difficult IV access often required central venous catheterization,&#xD;
      a procedure that can result in a number of serious complications (1). More recently,&#xD;
      ultrasound guidance has been touted as an effective means to achieve peripheral IV access on&#xD;
      these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which&#xD;
      seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within&#xD;
      one hour (2). Another study compared ultrasonographically guided peripheral IVs to&#xD;
      non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the&#xD;
      amount of time or the number of attempts it took to successfully place a peripheral IV (3).&#xD;
      Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in&#xD;
      being able to achieve rapid IV access in those patients who need IV access on an urgent&#xD;
      basis.&#xD;
&#xD;
      It seems that we still have room to improve our ability to obtain difficult IV access, and a&#xD;
      relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in&#xD;
      the upper extremities, targeting the brachial or basilic veins, but a recently described&#xD;
      technique --- the &quot;peripheral IJ&quot; --- involves placement of a peripheral IV catheter in the&#xD;
      internal jugular vein (4,5).&#xD;
&#xD;
      The peripheral IJ is gaining popularity in the investigators' ED as a solution to the&#xD;
      difficult vascular access patient. In the investigators' clinical experience, it is a quick&#xD;
      and easy procedure that is also safe, tolerated well by patients, and requires few resources.&#xD;
      Several small studies have concluded that this is a fast and safe procedure and a feasible&#xD;
      alternative to central access in the difficult vascular access patient (4-7). These studies&#xD;
      mention the theoretical risks as being similar to central venous access such as carotid&#xD;
      artery puncture, hematoma, pneumothorax, and line infection, however none of these have&#xD;
      actually been reported (4-7). Therefore, we seek primarily to determine the average number of&#xD;
      attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish&#xD;
      to determine: 1) the prevalence of potential complications related to this procedure 2) the&#xD;
      average time it takes the emergency physician to complete the procedure 3) the patient's&#xD;
      satisfaction with the procedure. We will compare the data from this study to the published&#xD;
      data for other types of ultrasound-guided peripheral IVs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">September 6, 2017</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>This study utilizes a convenience sample of patient who have difficult venous access with at least 2 attempts by nursing to achieve venous access. The patient will be consented and a physician placed ultrasound-guided peripheral IV will be placed in the internal jugular vein.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Successful Cannulation of the Internal Jugular Vein</measure>
    <time_frame>Less than 20 minutes</time_frame>
    <description>The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of Participants with successfully placed lines with a complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.</measure>
    <time_frame>Less than 20 minutes</time_frame>
    <description>The median time it took an Emergency Physician from needle puncture to cannulation in minutes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>IV Access</condition>
  <arm_group>
    <arm_group_label>US guided IJ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A physician placed ultrasound-guided IV in the internal jugular vein</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>US guided IJ</intervention_name>
    <description>IV catheter placement</description>
    <arm_group_label>US guided IJ</arm_group_label>
    <other_name>Ultrasound-guided Internal Jugular vein</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound-guided Internal Jugular vein</description>
    <arm_group_label>US guided IJ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 2 unsuccessful attempts at peripheral IV access by ED nursing&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients with clinical indications for emergent central venous access.&#xD;
&#xD;
          -  Overlying skin infection&#xD;
&#xD;
          -  External jugular vein easily visible for cannulation&#xD;
&#xD;
          -  Patient in law enforcement custody&#xD;
&#xD;
          -  Patient who is known to be pregnant or self identifies as pregnant&#xD;
&#xD;
          -  Patient lacking decision making capacity&#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>Joseph A Zitek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMCSN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center of Southen Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.</citation>
    <PMID>26557487</PMID>
  </reference>
  <reference>
    <citation>Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.</citation>
    <PMID>10577399</PMID>
  </reference>
  <reference>
    <citation>Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.</citation>
    <PMID>18824276</PMID>
  </reference>
  <reference>
    <citation>Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided &quot;peripheral IJ&quot;: internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.</citation>
    <PMID>22579025</PMID>
  </reference>
  <reference>
    <citation>Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.</citation>
    <PMID>26469683</PMID>
  </reference>
  <reference>
    <citation>Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.</citation>
    <PMID>26776533</PMID>
  </reference>
  <reference>
    <citation>Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.</citation>
    <PMID>22033389</PMID>
  </reference>
  <reference>
    <citation>Ash AJ, Raio C. Seldinger Technique for Placement of &quot;Peripheral&quot; Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.</citation>
    <PMID>26823937</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>October 15, 2018</results_first_submitted>
  <results_first_submitted_qc>January 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 15, 2019</results_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center of Southern Nevada</investigator_affiliation>
    <investigator_full_name>Joseph (Tony) Zitek, MD</investigator_full_name>
    <investigator_title>MD, Assistant Research Director, Emergency Medicine Residency Program</investigator_title>
  </responsible_party>
  <keyword>Peripheral IV</keyword>
  <keyword>Internal jugular vein</keyword>
  <keyword>IJ</keyword>
  <keyword>Peripheral IJ</keyword>
  <keyword>Ultrasound-guided IJ</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03231345/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>US Guided IJ</title>
          <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>US Guided IJ</title>
          <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.2" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Successful Cannulation of the Internal Jugular Vein</title>
        <description>The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.</description>
        <time_frame>Less than 20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>US Guided IJ</title>
            <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Cannulation of the Internal Jugular Vein</title>
          <description>The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.</title>
        <description>Percentage of Participants with successfully placed lines with a complication</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>US Guided IJ</title>
            <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.</title>
          <description>Percentage of Participants with successfully placed lines with a complication</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.</title>
        <description>The median time it took an Emergency Physician from needle puncture to cannulation in minutes</description>
        <time_frame>Less than 20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>US Guided IJ</title>
            <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
          </group>
        </group_list>
        <measure>
          <title>The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.</title>
          <description>The median time it took an Emergency Physician from needle puncture to cannulation in minutes</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="0.98" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We monitored for adverse events throughout the patient's hospitalization, the length of which ranged from a few hours to a maximum of 2 weeks.</time_frame>
      <desc>The adverse events that we tracked included local hematoma, pneumothorax, arterial puncture, bacteremia/line infection, and line thrombus. Trained research assistants watched line placement to assess for these complications. They also rechecked the line 1 hour after placement, and then once every 24 hours until the line was removed. They also checked the results of CXRs to look for pneumothoraces, and they checked blood cultures results.</desc>
      <group_list>
        <group group_id="E1">
          <title>US Guided IJ</title>
          <description>A physician placed ultrasound-guided IV in the internal jugular vein&#xD;
US guided IJ: IV catheter placement&#xD;
Ultrasound: Ultrasound-guided Internal Jugular vein</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Complications from IV line placement</sub_title>
                <description>The only complication found was a local hematoma.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Zitek</name_or_title>
      <organization>University Medical Center of Southern Nevada</organization>
      <phone>702-383-7885</phone>
      <email>zitek10@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03231345
org study id: 16.08.002
nct id: NCT03231345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Difficult venous access in some patients such as those with obesity, IV drug use, chronic
      illness, or vascular pathology often causes increased discomfort and delayed patient care due
      to multiple attempts to gain venous access. If access is achieved at all, it usually results
      in a much smaller catheter than needed to provide optimal care for the patient.
      Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the
      investigators' emergency department and is gaining popularity across the US. This study
      investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in
      the internal jugular vein.
Intravenous access in the emergency department (ED) patient is essential for medication
      delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of
      IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic
      illnesses, or vascular pathology may have difficult IV access. These patients are problematic
      for the busy ED nurse and physician as this can lead to a time consuming process, which slows
      efficiency and patient care.

      Previously, patients with difficult IV access often required central venous catheterization,
      a procedure that can result in a number of serious complications (1). More recently,
      ultrasound guidance has been touted as an effective means to achieve peripheral IV access on
      these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which
      seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within
      one hour (2). Another study compared ultrasonographically guided peripheral IVs to
      non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the
      amount of time or the number of attempts it took to successfully place a peripheral IV (3).
      Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in
      being able to achieve rapid IV access in those patients who need IV access on an urgent
      basis.

      It seems that we still have room to improve our ability to obtain difficult IV access, and a
      relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in
      the upper extremities, targeting the brachial or basilic veins, but a recently described
      technique --- the "peripheral IJ" --- involves placement of a peripheral IV catheter in the
      internal jugular vein (4,5).

      The peripheral IJ is gaining popularity in the investigators' ED as a solution to the
      difficult vascular access patient. In the investigators' clinical experience, it is a quick
      and easy procedure that is also safe, tolerated well by patients, and requires few resources.
      Several small studies have concluded that this is a fast and safe procedure and a feasible
      alternative to central access in the difficult vascular access patient (4-7). These studies
      mention the theoretical risks as being similar to central venous access such as carotid
      artery puncture, hematoma, pneumothorax, and line infection, however none of these have
      actually been reported (4-7). Therefore, we seek primarily to determine the average number of
      attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish
      to determine: 1) the prevalence of potential complications related to this procedure 2) the
      average time it takes the emergency physician to complete the procedure 3) the patient's
      satisfaction with the procedure. We will compare the data from this study to the published
      data for other types of ultrasound-guided peripheral IVs.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study utilizes a convenience sample of patient who have difficult venous access with at least 2 attempts by nursing to achieve venous access. The patient will be consented and a physician placed ultrasound-guided peripheral IV will be placed in the internal jugular vein.
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With Successful Cannulation of the Internal Jugular Vein
time frame: Less than 20 minutes
description: The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.
measure: Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
time frame: 24 hours
description: Percentage of Participants with successfully placed lines with a complication
measure: The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
time frame: Less than 20 minutes
description: The median time it took an Emergency Physician from needle puncture to cannulation in minutes
arm group label: US guided IJ
arm group type: Experimental
description: A physician placed ultrasound-guided IV in the internal jugular vein
intervention type: Procedure
intervention name: US guided IJ
description: IV catheter placement
arm group label: US guided IJ
other name: Ultrasound-guided Internal Jugular vein
intervention type: Device
intervention name: Ultrasound
description: Ultrasound-guided Internal Jugular vein
arm group label: US guided IJ
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph A Zitek, MD
role: Principal Investigator
affiliation: UMCSN
facility: 
country: United States
citation: Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
PMID: 26557487
citation: Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
PMID: 10577399
citation: Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
PMID: 18824276
citation: Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
PMID: 22579025
citation: Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.
PMID: 26469683
citation: Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.
PMID: 26776533
citation: Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.
PMID: 22033389
citation: Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.
PMID: 26823937
responsible party type: Principal Investigator
investigator affiliation: University Medical Center of Southern Nevada
investigator full name: Joseph (Tony) Zitek, MD
investigator title: MD, Assistant Research Director, Emergency Medicine Residency Program
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 