<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/NCT01680393</url>
  </required_header>
  <id_info>
    <org_study_id>BBH290511BRAINshoulderscd</org_study_id>
    <nct_id>NCT01680393</nct_id>
  </id_info>
  <brief_title>Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position</brief_title>
  <official_title>Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 3-legged randomized study examining whether during shoulder surgery performed&#xD;
      in the beach chair position active compressions of the lower leg with a sequential&#xD;
      compression device (SCD) have a superior effect on stabilizing cerebral and circulatory&#xD;
      hemodynamics when compared to TED stockings or a control group without any stockings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examines whether during shoulder surgery performed in the beach chair position&#xD;
      active compressions of the lower leg with a sequential compression device (SCD) have a&#xD;
      superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED&#xD;
      stockings or a control group without any stockings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2011</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cerebral oxygenation</measure>
    <time_frame>per minute</time_frame>
    <description>cerebral oxygenation averaged of 1 min during the operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ephedrine</measure>
    <time_frame>throughout duration of anaesthesia, approximately 60 minutes</time_frame>
    <description>amount of ephedrine used during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac output</measure>
    <time_frame>per minute</time_frame>
    <description>cardiac output averaged over 1 minute during the entire surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume</measure>
    <time_frame>per minute</time_frame>
    <description>stroke volume averaged over 1 minute during the entire surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial pressure</measure>
    <time_frame>per minute</time_frame>
    <description>MAP averaged over 1 minute during the entire surgery</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Sequential compression device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TED stockings</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no stockings will be applied to the patients legs</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sequential compression device</intervention_name>
    <description>a sequential compression device will be applied to the legs</description>
    <arm_group_label>Sequential compression device</arm_group_label>
    <other_name>SCD express Kendall</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TED stockings</intervention_name>
    <description>TED stockings will be applied to the patients legs during surgery</description>
    <arm_group_label>TED stockings</arm_group_label>
    <other_name>TED compression stockings, Kendall</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergoing elective shoulder surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  untreated hypertension&#xD;
&#xD;
          -  no pulse in a. dorsalis pedis or a.tibialis posterior&#xD;
&#xD;
          -  leg ulcers&#xD;
&#xD;
          -  failed scalenous blockade&#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>Frank Pott, MD,DMsc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Bispebjerg Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank Pott, MD, DMsc</last_name>
    <email>frank.pott@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen N</state>
        <zip>2200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Frank Pott, MD, DMsc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>February 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 4, 2012</last_update_submitted>
  <last_update_submitted_qc>September 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Frank Christian Pott, MD</investigator_full_name>
    <investigator_title>MD, DMSc</investigator_title>
  </responsible_party>
  <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/NCT01680393
org study id: BBH290511BRAINshoulderscd
nct id: NCT01680393
lead sponsor: 
has dmc: No
This study is a 3-legged randomized study examining whether during shoulder surgery performed
      in the beach chair position active compressions of the lower leg with a sequential
      compression device (SCD) have a superior effect on stabilizing cerebral and circulatory
      hemodynamics when compared to TED stockings or a control group without any stockings.
This study examines whether during shoulder surgery performed in the beach chair position
      active compressions of the lower leg with a sequential compression device (SCD) have a
      superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED
      stockings or a control group without any stockings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: cerebral oxygenation
time frame: per minute
description: cerebral oxygenation averaged of 1 min during the operation
measure: ephedrine
time frame: throughout duration of anaesthesia, approximately 60 minutes
description: amount of ephedrine used during surgery
measure: cardiac output
time frame: per minute
description: cardiac output averaged over 1 minute during the entire surgery
measure: Stroke volume
time frame: per minute
description: stroke volume averaged over 1 minute during the entire surgery
measure: mean arterial pressure
time frame: per minute
description: MAP averaged over 1 minute during the entire surgery
arm group label: Sequential compression device
arm group type: Experimental
description: During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.
arm group label: TED stockings
arm group type: Experimental
description: During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.
arm group label: Control
arm group type: No Intervention
description: no stockings will be applied to the patients legs
intervention type: Device
intervention name: Sequential compression device
description: a sequential compression device will be applied to the legs
arm group label: Sequential compression device
other name: SCD express Kendall
intervention type: Other
intervention name: TED stockings
description: TED stockings will be applied to the patients legs during surgery
arm group label: TED stockings
other name: TED compression stockings, Kendall
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frank Pott, MD,DMsc
role: Principal Investigator
affiliation: Department of Anesthesiology, Bispebjerg Hospital
last name: Frank Pott, MD, DMsc
email: frank.pott@gmail.com
facility: 
status: Recruiting
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Frank Christian Pott, MD
investigator title: MD, DMSc
mesh term: Hypotension