<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/NCT01676350</url>
  </required_header>
  <id_info>
    <org_study_id>299341</org_study_id>
    <nct_id>NCT01676350</nct_id>
  </id_info>
  <brief_title>Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction</brief_title>
  <official_title>Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>WellSpan Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>WellSpan Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      By doing this study, the investigators hope to learn whether patients with difficult to&#xD;
      obtain IV access who are treated with IO access are more satisfied with their care and have&#xD;
      better outcomes. The investigators are specifically studying the time difference between&#xD;
      groups and the difference in the number of attempts required to obtain vascular access and&#xD;
      begin to treat with fluids and medications. The study will also measure patient satisfaction&#xD;
      and procedural pain, the frequency of central line placement, the length of stay in the&#xD;
      hospital and emergency department, and adverse events to intravascular access to determine&#xD;
      whether IO access can improve these measures.&#xD;
&#xD;
      The investigators hypothesize that the use of a protocol utilizing an IO device for select&#xD;
      patients with failed IV access will reduce the time requirements to obtain vascular access,&#xD;
      reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no&#xD;
      negative impact on patient satisfaction compared to the current ED practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Successful Placement of a Functioning USGIV/IO</measure>
    <time_frame>at time of vascular access</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Successful Placements</measure>
    <time_frame>at time of vascular access</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Difficult Peripheral IV Access</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IO access using EZ-IO®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IO access using EZ-IO®</intervention_name>
    <description>IO line placed using an FDA-approved device called an EZ-IO®.</description>
    <arm_group_label>IO access using EZ-IO®</arm_group_label>
    <other_name>EZ-IO®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Hemodynamically stable&#xD;
&#xD;
          3. Speaks English&#xD;
&#xD;
          4. Able to consent&#xD;
&#xD;
          5. Has difficult IV access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients who are younger than 18 years of age, b) lack English fluency c) are unable to&#xD;
        give informed consent d) require immediate central venous access e) have a history of&#xD;
        osteomyelitis in the only target location of IO access f) have a fracture in the bone of&#xD;
        the only target IO site g) have received an IO in the last 24 hours of the only target site&#xD;
        h) are allergic to lidocaine i) pregnant or j) require a contrast CT scan as part of their&#xD;
        ED care will be excluded.&#xD;
&#xD;
        While pregnant patients may benefit from rescue access the use of lidocaine to anesthetize&#xD;
        the medullary space has not been studied in this population.&#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>Erik Kochert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>York Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>October 31, 2017</results_first_submitted>
  <results_first_submitted_qc>January 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2022</results_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraosseous (IO) vascular access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.</description>
        </group>
        <group group_id="P2">
          <title>&amp;Apos;IO Access Using EZ-IO®</title>
          <description>If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.&#xD;
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Standard of care</description>
        </group>
        <group group_id="B2">
          <title>IO Access</title>
          <description>IO access</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Successful Placement of a Functioning USGIV/IO</title>
        <time_frame>at time of vascular access</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.</description>
          </group>
          <group group_id="O2">
            <title>&amp;Apos;IO Access Using EZ-IO®</title>
            <description>If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.&#xD;
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Successful Placement of a Functioning USGIV/IO</title>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.7" spread="177.9"/>
                    <measurement group_id="O2" value="67.3" spread="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Successful Placements</title>
        <time_frame>at time of vascular access</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.</description>
          </group>
          <group group_id="O2">
            <title>IO Access Using EZ-IO®</title>
            <description>If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.&#xD;
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Successful Placements</title>
          <units>successful placements</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.</description>
        </group>
        <group group_id="E2">
          <title>&amp;Apos;IO Access Using EZ-IO®</title>
          <description>If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.&#xD;
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Brent Becker</name_or_title>
      <organization>WellSpan York Hospital</organization>
      <phone>717-851-2223</phone>
      <email>bbecker2@wellspan.org</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/NCT01676350
org study id: 299341
nct id: NCT01676350
lead sponsor: 
collaborator: 
has dmc: No
By doing this study, the investigators hope to learn whether patients with difficult to
      obtain IV access who are treated with IO access are more satisfied with their care and have
      better outcomes. The investigators are specifically studying the time difference between
      groups and the difference in the number of attempts required to obtain vascular access and
      begin to treat with fluids and medications. The study will also measure patient satisfaction
      and procedural pain, the frequency of central line placement, the length of stay in the
      hospital and emergency department, and adverse events to intravascular access to determine
      whether IO access can improve these measures.

      The investigators hypothesize that the use of a protocol utilizing an IO device for select
      patients with failed IV access will reduce the time requirements to obtain vascular access,
      reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no
      negative impact on patient satisfaction compared to the current ED practices.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Successful Placement of a Functioning USGIV/IO
time frame: at time of vascular access
measure: Number of Successful Placements
time frame: at time of vascular access
arm group label: Standard of care
arm group type: No Intervention
description: If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
arm group label: IO access using EZ-IO®
arm group type: Experimental
description: If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.
intervention type: Procedure
intervention name: IO access using EZ-IO®
description: IO line placed using an FDA-approved device called an EZ-IO®.
arm group label: IO access using EZ-IO®
other name: EZ-IO®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erik Kochert, MD
role: Principal Investigator
affiliation: York Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 