<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/NCT01663779</url>
  </required_header>
  <id_info>
    <org_study_id>1206010421</org_study_id>
    <nct_id>NCT01663779</nct_id>
  </id_info>
  <brief_title>Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters</brief_title>
  <official_title>Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arterial catheterization is frequently performed on critically ill patients for invasive&#xD;
      blood pressure monitoring and/or frequent blood draws, especially arterial blood gas&#xD;
      analysis. The distal part of the radial artery (wrist) is the preferred access site.&#xD;
&#xD;
      The potential complications of the procedure are mostly minor and comprise temporary&#xD;
      occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture&#xD;
      site. Major complications including vessel aneurysm or occlusion with threat to hand&#xD;
      viability are rare.&#xD;
&#xD;
      The standard approach to catheterization is &quot;blind&quot; puncture of the RA while locating its&#xD;
      pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel.&#xD;
      Alternatively ultrasound can be used to locate the vessel and guide needle insertion.&#xD;
&#xD;
      To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with&#xD;
      ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked&#xD;
      at the pooled data obtained from these. The results showed that ultrasound guidance increased&#xD;
      the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of&#xD;
      ultrasound also significantly reduced the time to successful catheterization, the number of&#xD;
      punctures as well as the amount of catheters required per procedure.&#xD;
&#xD;
      None of the prior randomized trials has been conducted in an ICU setting and in three out of&#xD;
      the four studies the arterial lines were placed in patients undergoing elective surgery. The&#xD;
      investigators hypothesized that ultrasound could improve first attempt success rate while&#xD;
      placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to&#xD;
      successful insertion and reduce complications.&#xD;
&#xD;
      The investigators plan to randomize patients to either a palpation technique or ultrasound&#xD;
      guided catheter insertion and record the above outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in a prospective randomized design on the patient population of&#xD;
      the Surgical Intensive Care Unit (SICU) at Yale New Haven Hospital. All SICU patients in whom&#xD;
      the indication for arterial catheterization has been established by the attending physician&#xD;
      will be eligible for consented randomization to either the &quot;Palpation&quot; or the &quot;Ultrasound&quot;&#xD;
      group.&#xD;
&#xD;
      Once consent from the patient or his/her surrogate has been obtained, eligible patients will&#xD;
      be randomized to either the &quot;Palpation&quot; or the &quot;Ultrasound&quot; group. Sequentially numbered&#xD;
      sealed envelopes will be maintained in the SICU.&#xD;
&#xD;
      Catheter insertion: The side of insertion (left/right arm) is chosen by the operator. The&#xD;
      wrist is positioned by the operator, the skin disinfected and the area draped in a sterile&#xD;
      fashion. &quot;Palpation&quot; group&quot;: The artery is punctured after location by palpation only.&#xD;
      &quot;Ultrasound&quot; group&quot;: The artery is punctured under real-time ultrasound only with the probe&#xD;
      draped in a sterile sheath. The time from the first skin puncture to confirmed intra-arterial&#xD;
      position of the catheter by observing blood return from the catheter is measured with a&#xD;
      chronometer by a second person. An arterial pressure waveform must be observed on the monitor&#xD;
      to validate intra-arterial catheter placement.&#xD;
&#xD;
      Radial artery cannulation will be performed using the &quot;Radial Artery Catheterization Set with&#xD;
      Integral Needle Protection&quot; (Ref. RA-04020-SP, Arrows International Inc., Reading PA 19605,&#xD;
      USA) containing a 20G catheter on a 22 gauge (22G) puncture needle and a 0.46 mm spring-wire&#xD;
      guide.&#xD;
&#xD;
      For ultrasound-guided catheter insertion, operators will use the &quot;Site-Rite 6 Ultrasound&#xD;
      System&quot; with a linear vascular access probe (5-10 MHz) (Bard Access Systems Inc., 605 North&#xD;
      5600 West, Salt Lake City, UT 84116, USA).&#xD;
&#xD;
      Operators: RA catheterization is a typical teaching procedure frequently performed in the&#xD;
      ICU. In our unit, arterial lines are placed by either post graduate year 2 (PGY-2) residents&#xD;
      (surgery &amp; anesthesia) rotating through the SICU on a monthly basis, or by mid-level&#xD;
      providers who are in the unit for indeterminate periods of time. For our study, this will be&#xD;
      an important point, as one of our goals will be to demonstrate a learning effect, which is&#xD;
      less likely to be observable among the PGY-2 residents who will be present in the unit for a&#xD;
      month only.&#xD;
&#xD;
      All operators will get instructions (lecture and hands-on training on vascular phantom at the&#xD;
      beginning of their SICU rotation) on the use of ultrasound for vascular access and will at&#xD;
      all times have the opportunity to exercise their skills on a vessel phantom. Each successful&#xD;
      vessel puncture on the vessel phantom must be recorded by the operator, including time and&#xD;
      date. For each operator performing the ultrasound-guided insertion on a patient, one of the&#xD;
      investigators will be present for supervision and data collection, but not for assistance&#xD;
      with insertion, unless required for failure after having used both methods.&#xD;
&#xD;
      Cross-over: After three failed attempts at catheterization with the allocated first method,&#xD;
      the alternative method must be used; the operator can opt to puncture the RA on the opposite&#xD;
      arm. Timing of the first method ends when the operator decides to abandon the third attempt.&#xD;
      Timing for the new method starts at the new first skin puncture.&#xD;
&#xD;
      Follow up: All catheters will be monitored daily and on days 1 and 3 with clinical and&#xD;
      ultrasound examination for the development of complications. The catheter will be followed&#xD;
      daily for functional outcomes defined as the quality of the arterial waveform on the monitor&#xD;
      and the ability to draw blood from the catheter. The day on which the catheter ceases to&#xD;
      function for each of these purposes will be recorded as well as the day of catheter removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to recruit further.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>First Pass Success When Attempting Arterial Catheterization.</measure>
    <time_frame>Immediate, upon study entry</time_frame>
    <description>first pass success when attempting arterial catheterization of the artery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Severe Sepsis</condition>
  <arm_group>
    <arm_group_label>Ultrasound radial artery catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided radial artery catheterization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Palpation based artery catheterization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blind insertion of radial artery catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guided radial artery catheterization.</intervention_name>
    <description>Radial artery catheters will be placed with the assistance of bedside ultrasound.</description>
    <arm_group_label>Ultrasound radial artery catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blind insertion of radial artery catheterization</intervention_name>
    <description>Radial artery catheters will be placed by the palpation technique only.</description>
    <arm_group_label>Palpation based artery catheterization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All surgical intensive care unit patients at Yale New Haven Hospital in whom the&#xD;
             indication for arterial catheterization has been established by the attending&#xD;
             physician will be eligible for consented randomization to either the &quot;Palpation&quot; or&#xD;
             the &quot;Ultrasound&quot; group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient or his/her surrogate declines to participate or the patient lacks a radial&#xD;
             artery into which a catheter can be place.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin M Schuster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>March 30, 2015</results_first_submitted>
  <results_first_submitted_qc>August 5, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 31, 2015</results_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultrasound Radial Artery Catheter</title>
          <description>Ultrasound guided radial artery catheterization.&#xD;
Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound.</description>
        </group>
        <group group_id="P2">
          <title>Palpation Based Artery Catheterization</title>
          <description>Blind insertion of radial artery catheterization&#xD;
Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="23"/>
              </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>Ultrasound Radial Artery Catheter</title>
          <description>Ultrasound guided radial artery catheterization.&#xD;
Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound.</description>
        </group>
        <group group_id="B2">
          <title>Palpation Based Artery Catheterization</title>
          <description>Blind insertion of radial artery catheterization&#xD;
Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only.</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="27"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="50"/>
          </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="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Gender was not collected as a baseline variable.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Pass Success When Attempting Arterial Catheterization.</title>
        <description>first pass success when attempting arterial catheterization of the artery</description>
        <time_frame>Immediate, upon study entry</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound</title>
            <description>ultrasound atery</description>
          </group>
          <group group_id="O2">
            <title>Palpation</title>
            <description>palpation artery</description>
          </group>
        </group_list>
        <measure>
          <title>First Pass Success When Attempting Arterial Catheterization.</title>
          <description>first pass success when attempting arterial catheterization of the artery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3</ci_lower_limit>
            <ci_upper_limit>7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>entire study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ultrasound</title>
          <description>ultrasound artery</description>
        </group>
        <group group_id="E2">
          <title>Palpation</title>
          <description>palpation artery</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>subcutaneous hematoma &lt;1cm</sub_title>
                <description>subcutaneous hematoma &lt;1cm developed in 1 patient in the ultrasound group. Resolved with no intervention in 3 days.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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>Kevin M. Schuster</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>203-785-2572</phone>
      <email>kevin.schuster@yale.edu</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/NCT01663779
org study id: 1206010421
nct id: NCT01663779
lead sponsor: 
has dmc: No
Arterial catheterization is frequently performed on critically ill patients for invasive
      blood pressure monitoring and/or frequent blood draws, especially arterial blood gas
      analysis. The distal part of the radial artery (wrist) is the preferred access site.

      The potential complications of the procedure are mostly minor and comprise temporary
      occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture
      site. Major complications including vessel aneurysm or occlusion with threat to hand
      viability are rare.

      The standard approach to catheterization is "blind" puncture of the RA while locating its
      pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel.
      Alternatively ultrasound can be used to locate the vessel and guide needle insertion.

      To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with
      ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked
      at the pooled data obtained from these. The results showed that ultrasound guidance increased
      the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of
      ultrasound also significantly reduced the time to successful catheterization, the number of
      punctures as well as the amount of catheters required per procedure.

      None of the prior randomized trials has been conducted in an ICU setting and in three out of
      the four studies the arterial lines were placed in patients undergoing elective surgery. The
      investigators hypothesized that ultrasound could improve first attempt success rate while
      placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to
      successful insertion and reduce complications.

      The investigators plan to randomize patients to either a palpation technique or ultrasound
      guided catheter insertion and record the above outcomes.
The study will be conducted in a prospective randomized design on the patient population of
      the Surgical Intensive Care Unit (SICU) at Yale New Haven Hospital. All SICU patients in whom
      the indication for arterial catheterization has been established by the attending physician
      will be eligible for consented randomization to either the "Palpation" or the "Ultrasound"
      group.

      Once consent from the patient or his/her surrogate has been obtained, eligible patients will
      be randomized to either the "Palpation" or the "Ultrasound" group. Sequentially numbered
      sealed envelopes will be maintained in the SICU.

      Catheter insertion: The side of insertion (left/right arm) is chosen by the operator. The
      wrist is positioned by the operator, the skin disinfected and the area draped in a sterile
      fashion. "Palpation" group": The artery is punctured after location by palpation only.
      "Ultrasound" group": The artery is punctured under real-time ultrasound only with the probe
      draped in a sterile sheath. The time from the first skin puncture to confirmed intra-arterial
      position of the catheter by observing blood return from the catheter is measured with a
      chronometer by a second person. An arterial pressure waveform must be observed on the monitor
      to validate intra-arterial catheter placement.

      Radial artery cannulation will be performed using the "Radial Artery Catheterization Set with
      Integral Needle Protection" (Ref. RA-04020-SP, Arrows International Inc., Reading PA 19605,
      USA) containing a 20G catheter on a 22 gauge (22G) puncture needle and a 0.46 mm spring-wire
      guide.

      For ultrasound-guided catheter insertion, operators will use the "Site-Rite 6 Ultrasound
      System" with a linear vascular access probe (5-10 MHz) (Bard Access Systems Inc., 605 North
      5600 West, Salt Lake City, UT 84116, USA).

      Operators: RA catheterization is a typical teaching procedure frequently performed in the
      ICU. In our unit, arterial lines are placed by either post graduate year 2 (PGY-2) residents
      (surgery & anesthesia) rotating through the SICU on a monthly basis, or by mid-level
      providers who are in the unit for indeterminate periods of time. For our study, this will be
      an important point, as one of our goals will be to demonstrate a learning effect, which is
      less likely to be observable among the PGY-2 residents who will be present in the unit for a
      month only.

      All operators will get instructions (lecture and hands-on training on vascular phantom at the
      beginning of their SICU rotation) on the use of ultrasound for vascular access and will at
      all times have the opportunity to exercise their skills on a vessel phantom. Each successful
      vessel puncture on the vessel phantom must be recorded by the operator, including time and
      date. For each operator performing the ultrasound-guided insertion on a patient, one of the
      investigators will be present for supervision and data collection, but not for assistance
      with insertion, unless required for failure after having used both methods.

      Cross-over: After three failed attempts at catheterization with the allocated first method,
      the alternative method must be used; the operator can opt to puncture the RA on the opposite
      arm. Timing of the first method ends when the operator decides to abandon the third attempt.
      Timing for the new method starts at the new first skin puncture.

      Follow up: All catheters will be monitored daily and on days 1 and 3 with clinical and
      ultrasound examination for the development of complications. The catheter will be followed
      daily for functional outcomes defined as the quality of the arterial waveform on the monitor
      and the ability to draw blood from the catheter. The day on which the catheter ceases to
      function for each of these purposes will be recorded as well as the day of catheter removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: First Pass Success When Attempting Arterial Catheterization.
time frame: Immediate, upon study entry
description: first pass success when attempting arterial catheterization of the artery
arm group label: Ultrasound radial artery catheter
arm group type: Experimental
description: Ultrasound guided radial artery catheterization.
arm group label: Palpation based artery catheterization
arm group type: Active Comparator
description: Blind insertion of radial artery catheterization
intervention type: Procedure
intervention name: Ultrasound guided radial artery catheterization.
description: Radial artery catheters will be placed with the assistance of bedside ultrasound.
arm group label: Ultrasound radial artery catheter
intervention type: Procedure
intervention name: Blind insertion of radial artery catheterization
description: Radial artery catheters will be placed by the palpation technique only.
arm group label: Palpation based artery catheterization
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin M Schuster, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 