<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/NCT02231463</url>
  </required_header>
  <id_info>
    <org_study_id>CVL-Position-1</org_study_id>
    <nct_id>NCT02231463</nct_id>
  </id_info>
  <brief_title>Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter</brief_title>
  <official_title>Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter as a Surrogate Parameter in Punctures of Central Veins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Köln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Köln</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 50 Patients who are undergoing a planned surgical procedure which require a central venous&#xD;
      catheter the diameter of the subclavian vein is measured by ultrasound under 6 different&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 50 Patients who are undergoing a planned surgical procedure which require a central venous&#xD;
      catheter the diameter of the subclavian vein is measured by ultrasound under 6 different&#xD;
      conditions. The conditions are&#xD;
&#xD;
        1. neutral positioning, PEEP 0 cm H2O,&#xD;
&#xD;
        2. neutral positioning, PEEP 5cm H2O,&#xD;
&#xD;
        3. neutral positioning, PEEP 10cm H2O,&#xD;
&#xD;
        4. Trendelenburg positioning -20°, PEEP 0 cmH2O,&#xD;
&#xD;
        5. Trendelenburg positioning -20°, PEEP 5 cmH2O,&#xD;
&#xD;
        6. Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous&#xD;
           catheter is used to measure the central venous pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Diameter of vein</measure>
    <time_frame>only 1 day (the day of the measurement); no follow-up is required</time_frame>
    <description>measurement of vein Diameter by ultrasound in a randomized order</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Insufficiency; Cardiac, Complicating Surgery</condition>
  <arm_group>
    <arm_group_label>ultrasound measurement</arm_group_label>
    <description>measuring subclavian vein Diameter in six Groups:&#xD;
neutral positioning, PEEP 0 cm H2O, neutral positioning, PEEP 5cm H2O, neutral positioning, PEEP 10cm H2O, Trendelenburg positioning -20°, PEEP 0 cmH2O, Trendelenburg positioning -20°, PEEP 5 cmH2O, Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous catheter is used to measure the central venous pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neutral positioning, PEEP 0 cm H2O</intervention_name>
    <description>neutral positioning, PEEP 0 cm H2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neutral positioning, PEEP 5cm H2O</intervention_name>
    <description>neutral positioning, PEEP 5cm H2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neutral positioning, PEEP 10cm H2O</intervention_name>
    <description>neutral positioning, PEEP 10cm H2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trendelenburg positioning -20°, PEEP 0 cmH2O</intervention_name>
    <description>Trendelenburg positioning -20°, PEEP 0 cmH2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trendelenburg positioning -20°, PEEP 5 cmH2O</intervention_name>
    <description>Trendelenburg positioning -20°, PEEP 5 cmH2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trendelenburg positioning -20°, PEEP 10 cmH2O</intervention_name>
    <description>Trendelenburg positioning -20°, PEEP 10 cmH2O</description>
    <arm_group_label>ultrasound measurement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing a operative procedure which requires a central venous catheter&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  cardiosurgery or neurosurgery&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  ECG: inus rhythm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peacemaker&#xD;
&#xD;
          -  kontraindications for PEEP&#xD;
&#xD;
          -  pulmonary disease&#xD;
&#xD;
          -  hemodynamically instable patients&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  pulmonal Hypertension&#xD;
&#xD;
          -  ejection fraction &lt; 35%&#xD;
&#xD;
          -  severe valvular disease&#xD;
&#xD;
          -  tricuspid insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jochen Hinkelbein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UK Köln</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UK Köln</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Köln</investigator_affiliation>
    <investigator_full_name>Jochen Hinkelbein</investigator_full_name>
    <investigator_title>PD Dr. med.</investigator_title>
  </responsible_party>
  <keyword>ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02231463
org study id: CVL-Position-1
nct id: NCT02231463
lead sponsor: 
has dmc: No
In 50 Patients who are undergoing a planned surgical procedure which require a central venous
      catheter the diameter of the subclavian vein is measured by ultrasound under 6 different
      conditions.
In 50 Patients who are undergoing a planned surgical procedure which require a central venous
      catheter the diameter of the subclavian vein is measured by ultrasound under 6 different
      conditions. The conditions are

        1. neutral positioning, PEEP 0 cm H2O,

        2. neutral positioning, PEEP 5cm H2O,

        3. neutral positioning, PEEP 10cm H2O,

        4. Trendelenburg positioning -20°, PEEP 0 cmH2O,

        5. Trendelenburg positioning -20°, PEEP 5 cmH2O,

        6. Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous
           catheter is used to measure the central venous pressure.
observational model: Case-Only
time perspective: Prospective
measure: Diameter of vein
time frame: only 1 day (the day of the measurement); no follow-up is required
description: measurement of vein Diameter by ultrasound in a randomized order
arm group label: ultrasound measurement
description: measuring subclavian vein Diameter in six Groups:
neutral positioning, PEEP 0 cm H2O, neutral positioning, PEEP 5cm H2O, neutral positioning, PEEP 10cm H2O, Trendelenburg positioning -20°, PEEP 0 cmH2O, Trendelenburg positioning -20°, PEEP 5 cmH2O, Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous catheter is used to measure the central venous pressure.
intervention type: Other
intervention name: neutral positioning, PEEP 0 cm H2O
description: neutral positioning, PEEP 0 cm H2O
arm group label: ultrasound measurement
intervention type: Other
intervention name: neutral positioning, PEEP 5cm H2O
description: neutral positioning, PEEP 5cm H2O
arm group label: ultrasound measurement
intervention type: Other
intervention name: neutral positioning, PEEP 10cm H2O
description: neutral positioning, PEEP 10cm H2O
arm group label: ultrasound measurement
intervention type: Other
intervention name: Trendelenburg positioning -20°, PEEP 0 cmH2O
description: Trendelenburg positioning -20°, PEEP 0 cmH2O
arm group label: ultrasound measurement
intervention type: Other
intervention name: Trendelenburg positioning -20°, PEEP 5 cmH2O
description: Trendelenburg positioning -20°, PEEP 5 cmH2O
arm group label: ultrasound measurement
intervention type: Other
intervention name: Trendelenburg positioning -20°, PEEP 10 cmH2O
description: Trendelenburg positioning -20°, PEEP 10 cmH2O
arm group label: ultrasound measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jochen Hinkelbein, MD
role: Principal Investigator
affiliation: UK Köln
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Köln
investigator full name: Jochen Hinkelbein
investigator title: PD Dr. med.
mesh term: Heart Failure