<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/NCT01707446</url>
  </required_header>
  <id_info>
    <org_study_id>11-0650-A</org_study_id>
    <nct_id>NCT01707446</nct_id>
  </id_info>
  <brief_title>Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery</brief_title>
  <official_title>Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a&#xD;
      serious complication that results in prolonged length of stay, increased health care costs&#xD;
      and is associated with higher death rates. The exact cause involved in the development of&#xD;
      delirium after cardiac surgery is unclear. The latest advancement in near-infrared&#xD;
      spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury.&#xD;
      This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery,&#xD;
      recording oxygenation in real time allowing the clinical team the opportunity to intervene&#xD;
      early to prevent ischemia and possibly preventing untoward events. Adverse events followed&#xD;
      include, but are not limited to, stroke, (transient ischemic attacks), heart attack,&#xD;
      (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure,&#xD;
      pneumonia, cause of death for 30-days after surgery (all cause mortality).&#xD;
&#xD;
      Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in&#xD;
      lower delirium rates after complex cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who suffer from delirium postoperatively</measure>
    <time_frame>Delirium we be assessed postoperatively for 7 days or Discharge</time_frame>
    <description>Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>Near-infrared reflectance spectroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blinded Near-infrared reflectance spectroscopy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)</intervention_name>
    <description>In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.</description>
    <arm_group_label>Near-infrared reflectance spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>An alarm threshold at 75% of the baseline rSO2 value</intervention_name>
    <description>If the threshold of &lt; 75% from baseline is reached for &gt; 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.</description>
    <arm_group_label>Near-infrared reflectance spectroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 60 years&#xD;
&#xD;
          -  combined valve and CABG&#xD;
&#xD;
          -  repeat cardiac surgery&#xD;
&#xD;
          -  multiple valve replacement or repair&#xD;
&#xD;
          -  surgery of ascending aorta and aortic arch&#xD;
&#xD;
          -  signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac surgery without the use of cardiopulmonary bypass&#xD;
&#xD;
          -  symptomatic cerebrovascular disease,&#xD;
&#xD;
          -  history of delirium, or&#xD;
&#xD;
          -  schizophrenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Heatlh Network, Toronto General Hopsital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>December 12, 2011</study_first_submitted>
  <study_first_submitted_qc>October 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac surgery</keyword>
  <keyword>Delirium</keyword>
  <keyword>Cerebral Oximetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Heart Diseases</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/NCT01707446
org study id: 11-0650-A
nct id: NCT01707446
lead sponsor: 
has dmc: No
Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a
      serious complication that results in prolonged length of stay, increased health care costs
      and is associated with higher death rates. The exact cause involved in the development of
      delirium after cardiac surgery is unclear. The latest advancement in near-infrared
      spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury.
      This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery,
      recording oxygenation in real time allowing the clinical team the opportunity to intervene
      early to prevent ischemia and possibly preventing untoward events. Adverse events followed
      include, but are not limited to, stroke, (transient ischemic attacks), heart attack,
      (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure,
      pneumonia, cause of death for 30-days after surgery (all cause mortality).

      Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in
      lower delirium rates after complex cardiac surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of patients who suffer from delirium postoperatively
time frame: Delirium we be assessed postoperatively for 7 days or Discharge
description: Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
arm group label: Near-infrared reflectance spectroscopy
arm group type: Active Comparator
description: Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established.
arm group label: Blinded Near-infrared reflectance spectroscopy
arm group type: No Intervention
description: In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design.
intervention type: Device
intervention name: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
description: In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.
arm group label: Near-infrared reflectance spectroscopy
intervention type: Other
intervention name: An alarm threshold at 75% of the baseline rSO2 value
description: If the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.
arm group label: Near-infrared reflectance spectroscopy
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Delirium
mesh term: Heart Diseases