<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/NCT03812926</url>
  </required_header>
  <id_info>
    <org_study_id>EESOA1</org_study_id>
    <nct_id>NCT03812926</nct_id>
  </id_info>
  <brief_title>Compuflo® vs Conventional Training With an Epidural Simulator</brief_title>
  <official_title>Compuflo® Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum With an Epidural Simulator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European e-Learning School in Obstetric Anesthesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European e-Learning School in Obstetric Anesthesia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epidural block is one of the most difficult skills that can be mastered by trainees probably&#xD;
      due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance&#xD;
      technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in&#xD;
      real-time at the orifice of a needle and it has been successfully used in clinical practice&#xD;
      to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may&#xD;
      help trainees to identify the ligamentum flavum using a realistic Epidural Simulator&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators enrolled 60 trainees who have never performed an epidural block. After&#xD;
      having had a standardized learning module on epidural anatomy and technique, each trainee&#xD;
      practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5&#xD;
      attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an&#xD;
      increase of resistance due to the penetration of the needle in the LF. The correct position&#xD;
      of the needle was verified by an expert instructor. The number of attempts was noted. The&#xD;
      power analysis required a sample size of 60 observations to set 80% test power and a 95%&#xD;
      significance. Unpaired T-test was used to evaluate the differences in the number of epidural&#xD;
      attempts. A logistic regression model was used to correlate the &quot;success at the first attempt&#xD;
      ratio&quot; and the technique used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">January 20, 2019</completion_date>
  <primary_completion_date type="Actual">January 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>epidural attempts</measure>
    <time_frame>10 minutes</time_frame>
    <description>number of attempts to correctly identify the epidural space</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Epidural Simulator</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compuflo assited procedure</intervention_name>
    <description>number of needle entry required to identify the ligamentum flavum</description>
    <other_name>Standard assisted procedure</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First year trainees in anesthesia who never have performed an epidural block&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        First year trainees in anesthesia who never have performed an epidural block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Giorgio Capogna</last_name>
    <role>Study Director</role>
    <affiliation>European e-Learning School in Obstetric Anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EESOA Maternal Neonatal Simulation Centre</name>
      <address>
        <city>Roma</city>
        <zip>00151</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812926
org study id: EESOA1
nct id: NCT03812926
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Epidural block is one of the most difficult skills that can be mastered by trainees probably
      due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance
      technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in
      real-time at the orifice of a needle and it has been successfully used in clinical practice
      to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may
      help trainees to identify the ligamentum flavum using a realistic Epidural Simulator
The investigators enrolled 60 trainees who have never performed an epidural block. After
      having had a standardized learning module on epidural anatomy and technique, each trainee
      practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5
      attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an
      increase of resistance due to the penetration of the needle in the LF. The correct position
      of the needle was verified by an expert instructor. The number of attempts was noted. The
      power analysis required a sample size of 60 observations to set 80% test power and a 95%
      significance. Unpaired T-test was used to evaluate the differences in the number of epidural
      attempts. A logistic regression model was used to correlate the "success at the first attempt
      ratio" and the technique used.
observational model: Cohort
time perspective: Prospective
measure: epidural attempts
time frame: 10 minutes
description: number of attempts to correctly identify the epidural space
intervention type: Device
intervention name: Compuflo assited procedure
description: number of needle entry required to identify the ligamentum flavum
other name: Standard assisted procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 26 Years
maximum age: 35 Years
last name: Giorgio Capogna
role: Study Director
affiliation: European e-Learning School in Obstetric Anesthesia
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: No