<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/NCT01712750</url>
  </required_header>
  <id_info>
    <org_study_id>REB-17456</org_study_id>
    <nct_id>NCT01712750</nct_id>
  </id_info>
  <brief_title>Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will&#xD;
      be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a&#xD;
      non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to&#xD;
      determine whether changes in VOT measurements occur in patients during cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">September 2011</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>VOT reperfusion slope</measure>
    <time_frame>Intra-operative (within 12 hours)</time_frame>
    <description>Reperfusion slope as measured during vascular occlusion test in units of %/s</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Vascular Occlusion Test</condition>
  <arm_group>
    <arm_group_label>VOT on bypass</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Elective cardiac surgery patients undergoing coronary artery bypass and valve surgery using&#xD;
        cardiopulmonary bypass.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, elective cardiac surgery patients&#xD;
&#xD;
          -  Procedure using cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to pneumatic cuff inflation&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Significant peripheral vascular disease of the arms&#xD;
&#xD;
          -  Emergency surgery&#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>John M Murkin, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <keyword>Regional tissue oximetry</keyword>
  <keyword>Cardiopulmonary bypass</keyword>
  <keyword>Cardiac surgical procedures</keyword>
  <!-- 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/NCT01712750
org study id: REB-17456
nct id: NCT01712750
lead sponsor: 
has dmc: No
Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will
      be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a
      non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to
      determine whether changes in VOT measurements occur in patients during cardiac surgery.
observational model: Cohort
time perspective: Prospective
measure: VOT reperfusion slope
time frame: Intra-operative (within 12 hours)
description: Reperfusion slope as measured during vascular occlusion test in units of %/s
arm group label: VOT on bypass
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John M Murkin, MD, FRCPC
role: Principal Investigator
affiliation: London Health Sciences Centre
facility: 
country: Canada