<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/NCT03231696</url>
  </required_header>
  <id_info>
    <org_study_id>Visibility</org_study_id>
    <nct_id>NCT03231696</nct_id>
  </id_info>
  <brief_title>Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks</brief_title>
  <acronym>Visibility</acronym>
  <official_title>Visibility - A Novel Classification Score of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We assessed the visibility of peripheral nerves while ultrasound guided blockades with a&#xD;
      novel scoring system to evaluate differences in visibility of different nerves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We assessed the visibility of peripheral nerves while ultrasound guided blockades with a&#xD;
      novel scoring system to evaluate differences in visibility of different nerves.&#xD;
&#xD;
      VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2&#xD;
      identification and visualisation of all structures after some corrections VIS 3&#xD;
      identification and visualisation of structures only unsure VIS 4 identification and&#xD;
      visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project&#xD;
      in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visibility</measure>
    <time_frame>During regional block (an average of 1 hour)</time_frame>
    <description>The ultrasound visibility of the nerve scored by a 5-step scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional analgesia</measure>
    <time_frame>During surgery (an average of 4 hours)</time_frame>
    <description>The need and amount of additional analgetic drugs while the intervention.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1200</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Patients receiving Regional Anesthesia</arm_group_label>
    <description>All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients 18 years or older with a peripheral nerve block at Charité -&#xD;
        Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (study sample N=1200):&#xD;
&#xD;
          -  peripheral nerve block by ultrasound guidance&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications for regional anesthesia&#xD;
&#xD;
        Inclusion Criteria (study sample as of amendment n=46):&#xD;
&#xD;
          -  peripheral nerve block by ultrasound guidance&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications for regional anesthesia (study sample n=46)&#xD;
&#xD;
          -  using not the standard ultrasound machine&#xD;
&#xD;
          -  performing not a standard regional anesthesia&#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>Jürgen Birnbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Jurgen Birnbaum</investigator_full_name>
    <investigator_title>Senior physician of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK</investigator_title>
  </responsible_party>
  <keyword>nerve block</keyword>
  <keyword>peripheral nerve stimulation</keyword>
  <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/NCT03231696
org study id: Visibility
nct id: NCT03231696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a
      novel scoring system to evaluate differences in visibility of different nerves.
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a
      novel scoring system to evaluate differences in visibility of different nerves.

      VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2
      identification and visualisation of all structures after some corrections VIS 3
      identification and visualisation of structures only unsure VIS 4 identification and
      visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project
      in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.
observational model: Cohort
time perspective: Retrospective
measure: Visibility
time frame: During regional block (an average of 1 hour)
description: The ultrasound visibility of the nerve scored by a 5-step scale.
measure: Additional analgesia
time frame: During surgery (an average of 4 hours)
description: The need and amount of additional analgetic drugs while the intervention.
arm group label: Patients receiving Regional Anesthesia
description: All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jürgen Birnbaum, MD
role: Principal Investigator
affiliation: Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Jurgen Birnbaum
investigator title: Senior physician of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
sharing ipd: No