<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/NCT03826186</url>
  </required_header>
  <id_info>
    <org_study_id>201812716</org_study_id>
    <nct_id>NCT03826186</nct_id>
  </id_info>
  <brief_title>CompuFlo Thoracic Epidural Study</brief_title>
  <official_title>Traditional Loss-of-resistance Technique vs Compuflo-aided Technology for Placement of a Thoracic Epidural Catheter: a Randomized Trial of the Effect on the Success Rate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>YATISH SIDDAPURA RANGANATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditionally, loss-of-resistance (LOR) to air or saline with a special ground-glass syringe&#xD;
      is the technique used to identify epidural space, but failure rates up to 30% have been&#xD;
      reported using this technique for thoracic epidural placement. This failure rate has sparked&#xD;
      the search for newer techniques to improve the success rate for placement.The CompuFlo&#xD;
      epidural system is a device that provides anesthesiologists and other healthcare providers&#xD;
      the ability to quantitatively determine and document the pressure at the needle tip in real&#xD;
      time. The device's proprietary dynamic pressure sensing technology (DPS) allows it to provide&#xD;
      objective visual and audible in-tissue pressure feedback that allows anesthesiologists to&#xD;
      identify the epidural space. The purpose this research study is to compare the success rate&#xD;
      of the two different approaches (traditional method v/s CompuFlo assisted) to thoracic&#xD;
      epidural placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditional technique vs CompuFlo use: Using the traditional technique (loss-of-resistance&#xD;
      technique), the epidural needle is advanced through the subcutaneous tissues with the needle&#xD;
      stylet in place until the needle tip is positioned in the interspinous ligament-this is noted&#xD;
      by the proceduralist by an increase in tissue resistance (attempted injection into&#xD;
      ligamentous tissue is met with high resistance). The stylet or introducer is removed, and a&#xD;
      ground-glass syringe filled with 2-3 mL of saline with an air bubble is attached to the hub&#xD;
      of the epidural needle. If the tip of the needle is within the ligament, gentle attempts at&#xD;
      injection are met with resistance, and injection of the saline is not possible. The needle is&#xD;
      then slowly advanced, millimeter by millimeter, with either continuous or rapidly repeating&#xD;
      attempts at injection. As the tip of the needle enters the posterior epidural space, a sudden&#xD;
      loss of resistance is noted, and the saline injects easily. Once the needle tip is in the&#xD;
      epidural space, the epidural catheter is threaded through the needle and the needle is&#xD;
      removed, leaving the catheter sited in the epidural space.&#xD;
&#xD;
      The CompuFlo technique complements this basic technique. Similar to the traditional&#xD;
      technique, the needle is advanced through the subcutaneous tissues with the stylet in place&#xD;
      until the interspinous ligament is entered, as noted by an increase in tissue resistance.&#xD;
      After removing the stylet, flexible tubing from the CompuFlo disposable tubing-syringe set is&#xD;
      attached to the hub of the needle instead of the traditional ground-glass syringe. The&#xD;
      fluid-filled syringe is placed in the CompuFlo device. The needle is then advanced&#xD;
      continuously with the device electronically sensing pressure in real time, providing a&#xD;
      numerical value (100 to 150 mm Hg) on the read-out screen. As the tip of the needle enters&#xD;
      the posterior epidural space, a sudden loss of resistance (associated with a significant loss&#xD;
      of pressure to less than 50 mm Hg or 50% of the starting pressure) is noted. The pressure&#xD;
      drop needs to be sustained for at least 5 seconds. An audio signal also signals the acute&#xD;
      change in pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>
    <intervention_model_description>Thoracic epidurals are administered. After randomization, one group will receive thoracic epidurals in the traditional way (control group) and the other with CompuFlo assistance (study group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Successful Thoracic Epidural Catheter Placement</measure>
    <time_frame>Maximum 20 minutes post administration of epidural test dose</time_frame>
    <description>Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of Time Required to Complete the Procedure</measure>
    <time_frame>During procedure, assessed up to 15 minutes</time_frame>
    <description>Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Loss of Cold Sensation at Various Time Points</measure>
    <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
    <description>Record the time it takes for loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure</measure>
    <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
    <description>Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Significant Change in Systolic Blood Pressure</measure>
    <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
    <description>A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Whose Provider Answered &quot;Yes&quot; or &quot;No&quot; to Ease of Catheter Placement</measure>
    <time_frame>During procedure, assessed up to 15 minutes</time_frame>
    <description>The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a &quot;yes&quot; or &quot;no&quot; evaluation asked and answered at the end of the procedure. The question asked was &quot;Was the catheter placement (threading) smooth after loss of resistance?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Positive Meniscus Test</measure>
    <time_frame>During procedure, assessed up to 15 minutes</time_frame>
    <description>The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unintentional Dural Puncture</measure>
    <time_frame>During procedure, assessed up to 15 minutes</time_frame>
    <description>The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Thoracic Epidural Anesthesia</condition>
  <arm_group>
    <arm_group_label>Traditional epidural group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CompuFlo epidural group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Traditional (loss-of-resistance technique) thoracic epidural placement</intervention_name>
    <description>Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
    <arm_group_label>Traditional epidural group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CompuFlo thoracic epidural placement</intervention_name>
    <description>Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
    <arm_group_label>CompuFlo epidural group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 70&#xD;
&#xD;
          -  BMI: 18 to 50 kg/m2&#xD;
&#xD;
          -  Require pain control for major thoracic or abdominal surgeries&#xD;
&#xD;
          -  Require pain control for rib fractures&#xD;
&#xD;
          -  English is the subject's first language&#xD;
&#xD;
          -  Must be able to signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: Less than 18 and older than 70&#xD;
&#xD;
          -  Must be free of significant valvular heart disease&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Contraindication to thoracic epidural anesthesia&#xD;
&#xD;
          -  Allergy or hypersensitivity to local anesthetics&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yatish S Ranganath, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.</citation>
    <PMID>14612482</PMID>
  </results_reference>
  <results_reference>
    <citation>Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.</citation>
    <PMID>12218518</PMID>
  </results_reference>
  <results_reference>
    <citation>Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.</citation>
    <PMID>18936379</PMID>
  </results_reference>
  <results_reference>
    <citation>Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.</citation>
    <PMID>26469364</PMID>
  </results_reference>
  <results_reference>
    <citation>Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.</citation>
    <PMID>27922948</PMID>
  </results_reference>
  <results_reference>
    <citation>Gong Y, Shi H, Wu J, Labu D, Sun J, Zhong H, Li L, Xin X, Wang L, Wu L, Ma D. Pressure waveform-guided epidural catheter placement in comparison to the loss-of-resistance conventional method. J Clin Anesth. 2014 Aug;26(5):395-401. doi: 10.1016/j.jclinane.2014.01.015. Epub 2014 Aug 27.</citation>
    <PMID>25172504</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>July 25, 2022</results_first_submitted>
  <results_first_submitted_qc>September 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2022</results_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>YATISH SIDDAPURA RANGANATH</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>CompuFlo; dynamic pressure sensing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.</ipd_access_criteria>
  </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>November 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03826186/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03826186/SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03826186/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Traditional Epidural Group</title>
          <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
        </group>
        <group group_id="P2">
          <title>CompuFlo Epidural Group</title>
          <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Traditional Epidural Group</title>
          <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
        </group>
        <group group_id="B2">
          <title>CompuFlo Epidural Group</title>
          <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</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="57"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="117"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="57"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="11.34"/>
                    <measurement group_id="B2" value="57.9" spread="11.38"/>
                    <measurement group_id="B3" value="57.9" spread="11.36"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="57"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="57"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Successful Thoracic Epidural Catheter Placement</title>
        <description>Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</description>
        <time_frame>Maximum 20 minutes post administration of epidural test dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Thoracic Epidural Catheter Placement</title>
          <description>Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</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="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Time Required to Complete the Procedure</title>
        <description>Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient</description>
        <time_frame>During procedure, assessed up to 15 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Time Required to Complete the Procedure</title>
          <description>Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.02" spread="7.4"/>
                    <measurement group_id="O2" value="7.4" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Loss of Cold Sensation at Various Time Points</title>
        <description>Record the time it takes for loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</description>
        <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Loss of Cold Sensation at Various Time Points</title>
          <description>Record the time it takes for loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Loss of cold sensation-10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of cold sensation-20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change in cold sensation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure</title>
        <description>Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).</description>
        <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure</title>
          <description>Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102" spread="14"/>
                    <measurement group_id="O2" value="102" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20-minutes after initial test dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="16"/>
                    <measurement group_id="O2" value="83" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Significant Change in Systolic Blood Pressure</title>
        <description>A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.</description>
        <time_frame>Up to 20 minutes post administration of epidural test dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Significant Change in Systolic Blood Pressure</title>
          <description>A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.</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="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Whose Provider Answered &quot;Yes&quot; or &quot;No&quot; to Ease of Catheter Placement</title>
        <description>The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a &quot;yes&quot; or &quot;no&quot; evaluation asked and answered at the end of the procedure. The question asked was &quot;Was the catheter placement (threading) smooth after loss of resistance?&quot;</description>
        <time_frame>During procedure, assessed up to 15 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Provider Answered &quot;Yes&quot; or &quot;No&quot; to Ease of Catheter Placement</title>
          <description>The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a &quot;yes&quot; or &quot;no&quot; evaluation asked and answered at the end of the procedure. The question asked was &quot;Was the catheter placement (threading) smooth after loss of resistance?&quot;</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Positive Meniscus Test</title>
        <description>The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.</description>
        <time_frame>During procedure, assessed up to 15 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Positive Meniscus Test</title>
          <description>The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.</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="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unintentional Dural Puncture</title>
        <description>The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.</description>
        <time_frame>During procedure, assessed up to 15 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Epidural Group</title>
            <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
          </group>
          <group group_id="O2">
            <title>CompuFlo Epidural Group</title>
            <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unintentional Dural Puncture</title>
          <description>The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.</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="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The data was collected from the time of consent until 48 hours post procedure.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Traditional Epidural Group</title>
          <description>The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.&#xD;
Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique.</description>
        </group>
        <group group_id="E2">
          <title>CompuFlo Epidural Group</title>
          <description>This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.&#xD;
CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.</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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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>Vice Chair for Research</name_or_title>
      <organization>University of Iowa Hospitals and Clinics</organization>
      <phone>319-335-9595</phone>
      <email>donna-hammond@uiowa.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/NCT03826186
org study id: 201812716
nct id: NCT03826186
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Traditionally, loss-of-resistance (LOR) to air or saline with a special ground-glass syringe
      is the technique used to identify epidural space, but failure rates up to 30% have been
      reported using this technique for thoracic epidural placement. This failure rate has sparked
      the search for newer techniques to improve the success rate for placement.The CompuFlo
      epidural system is a device that provides anesthesiologists and other healthcare providers
      the ability to quantitatively determine and document the pressure at the needle tip in real
      time. The device's proprietary dynamic pressure sensing technology (DPS) allows it to provide
      objective visual and audible in-tissue pressure feedback that allows anesthesiologists to
      identify the epidural space. The purpose this research study is to compare the success rate
      of the two different approaches (traditional method v/s CompuFlo assisted) to thoracic
      epidural placement.
Traditional technique vs CompuFlo use: Using the traditional technique (loss-of-resistance
      technique), the epidural needle is advanced through the subcutaneous tissues with the needle
      stylet in place until the needle tip is positioned in the interspinous ligament-this is noted
      by the proceduralist by an increase in tissue resistance (attempted injection into
      ligamentous tissue is met with high resistance). The stylet or introducer is removed, and a
      ground-glass syringe filled with 2-3 mL of saline with an air bubble is attached to the hub
      of the epidural needle. If the tip of the needle is within the ligament, gentle attempts at
      injection are met with resistance, and injection of the saline is not possible. The needle is
      then slowly advanced, millimeter by millimeter, with either continuous or rapidly repeating
      attempts at injection. As the tip of the needle enters the posterior epidural space, a sudden
      loss of resistance is noted, and the saline injects easily. Once the needle tip is in the
      epidural space, the epidural catheter is threaded through the needle and the needle is
      removed, leaving the catheter sited in the epidural space.

      The CompuFlo technique complements this basic technique. Similar to the traditional
      technique, the needle is advanced through the subcutaneous tissues with the stylet in place
      until the interspinous ligament is entered, as noted by an increase in tissue resistance.
      After removing the stylet, flexible tubing from the CompuFlo disposable tubing-syringe set is
      attached to the hub of the needle instead of the traditional ground-glass syringe. The
      fluid-filled syringe is placed in the CompuFlo device. The needle is then advanced
      continuously with the device electronically sensing pressure in real time, providing a
      numerical value (100 to 150 mm Hg) on the read-out screen. As the tip of the needle enters
      the posterior epidural space, a sudden loss of resistance (associated with a significant loss
      of pressure to less than 50 mm Hg or 50% of the starting pressure) is noted. The pressure
      drop needs to be sustained for at least 5 seconds. An audio signal also signals the acute
      change in pressure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Thoracic epidurals are administered. After randomization, one group will receive thoracic epidurals in the traditional way (control group) and the other with CompuFlo assistance (study group).
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants With Successful Thoracic Epidural Catheter Placement
time frame: Maximum 20 minutes post administration of epidural test dose
description: Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.
measure: Amount of Time Required to Complete the Procedure
time frame: During procedure, assessed up to 15 minutes
description: Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient
measure: Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
time frame: Up to 20 minutes post administration of epidural test dose
description: Record the time it takes for loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.
measure: Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure
time frame: Up to 20 minutes post administration of epidural test dose
description: Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).
measure: Number of Participants With Significant Change in Systolic Blood Pressure
time frame: Up to 20 minutes post administration of epidural test dose
description: A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.
measure: Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement
time frame: During procedure, assessed up to 15 minutes
description: The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a "yes" or "no" evaluation asked and answered at the end of the procedure. The question asked was "Was the catheter placement (threading) smooth after loss of resistance?"
measure: Number of Participants With a Positive Meniscus Test
time frame: During procedure, assessed up to 15 minutes
description: The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.
measure: Number of Participants With Unintentional Dural Puncture
time frame: During procedure, assessed up to 15 minutes
description: The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.
arm group label: Traditional epidural group
arm group type: Active Comparator
description: The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.
arm group label: CompuFlo epidural group
arm group type: Experimental
description: This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.
intervention type: Device
intervention name: Traditional (loss-of-resistance technique) thoracic epidural placement
description: Thoracic epidurals will be administered using the traditional loss-of resistance technique.
arm group label: Traditional epidural group
intervention type: Device
intervention name: CompuFlo thoracic epidural placement
description: Pressure sensing technology to consistently and accurately identify the thoracic epidural space.
arm group label: CompuFlo epidural group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yatish S Ranganath, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
citation: Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
PMID: 14612482
citation: Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.
PMID: 12218518
citation: Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.
PMID: 18936379
citation: Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
PMID: 26469364
citation: Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.
PMID: 27922948
citation: Gong Y, Shi H, Wu J, Labu D, Sun J, Zhong H, Li L, Xin X, Wang L, Wu L, Ma D. Pressure waveform-guided epidural catheter placement in comparison to the loss-of-resistance conventional method. J Clin Anesth. 2014 Aug;26(5):395-401. doi: 10.1016/j.jclinane.2014.01.015. Epub 2014 Aug 27.
PMID: 25172504
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: YATISH SIDDAPURA RANGANATH
investigator title: Clinical Assistant Professor
mesh term: Aortic Dissection
sharing ipd: Yes
ipd description: All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
ipd access criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 