<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/NCT01732133</url>
  </required_header>
  <id_info>
    <org_study_id>2012/27</org_study_id>
    <secondary_id>2012-A00811-42</secondary_id>
    <nct_id>NCT01732133</nct_id>
  </id_info>
  <brief_title>Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension</brief_title>
  <acronym>NEXFIN-CESAR</acronym>
  <official_title>Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric&#xD;
      measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could&#xD;
      help to detect hypotension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">January 22, 2016</completion_date>
  <primary_completion_date type="Actual">January 22, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between Nexfin and intermittent measurements of blood pressure</measure>
    <time_frame>two years</time_frame>
    <description>Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve between both measurements</measure>
    <time_frame>two years</time_frame>
    <description>Analysis concerns data from intrathecal injection to childbirth</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Measurement of arterial pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nexfin</intervention_name>
    <arm_group_label>Measurement of arterial pressure</arm_group_label>
    <other_name>Continuous measurement of arterial pressure using Nexfin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergoing elective cesarean delivery performed under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a heart rhythm disorder, Raynaud's disease or a history of vascular&#xD;
             surgery of the upper limb&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Fischler, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois</city>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypotension</keyword>
  <keyword>Cesarean delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01732133
org study id: 2012/27
secondary id: 2012-A00811-42
nct id: NCT01732133
lead sponsor: 
has dmc: No
Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric
      measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could
      help to detect hypotension.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison between Nexfin and intermittent measurements of blood pressure
time frame: two years
description: Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth
measure: Area under the curve between both measurements
time frame: two years
description: Analysis concerns data from intrathecal injection to childbirth
arm group label: Measurement of arterial pressure
arm group type: Experimental
intervention type: Device
intervention name: Nexfin
arm group label: Measurement of arterial pressure
other name: Continuous measurement of arterial pressure using Nexfin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Fischler, MD
role: Study Chair
affiliation: Hopital Foch
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypotension