<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/NCT03805880</url>
  </required_header>
  <id_info>
    <org_study_id>SATURIMETRIA</org_study_id>
    <nct_id>NCT03805880</nct_id>
  </id_info>
  <brief_title>Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery</brief_title>
  <official_title>Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</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>
      The purpose of this study prospective observational study is to determine cognitive&#xD;
      dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral&#xD;
      oxygen desaturations and hypertension as risk factors for post-operative cognitive&#xD;
      dysfunction (POCD) in patients undergoing lung resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of cognitive dysfunction after thoracic surgery</measure>
    <time_frame>change of MMSE score from the day before surgery (baseline) at 1 day after surgery</time_frame>
    <description>A decrease in Mini-Mental State Examination (MMSE) score &gt; 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.</measure>
    <time_frame>change of cerebral saturation from baseline(before surgery) at intraoperative measure</time_frame>
    <description>monitoring values of cerebral saturation during intraoperative period:Cerebral desaturation was defined as a reduction of rSO2 during OLV of more than 20% from the baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>role of hypertension as risk factors for POCD in patients undergoing lung resection.</measure>
    <time_frame>change of blood pressure from baseline(before surgery) at intraoperative measure</time_frame>
    <description>monitoring values of blood pressure during intraoperative period</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>Cognitive Dysfunction</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cerebral desaturation monitoring and cognitive examination</intervention_name>
    <description>Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an&#xD;
        OLV duration ≥ 45 min&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for elective lobectomy or wedge resection via thoracotomy&#xD;
&#xD;
          -  one lung ventilation (OLV duration) ≥ 45 min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous cerebral disease,&#xD;
&#xD;
          -  dementia,&#xD;
&#xD;
          -  severe cognitive dysfunction&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patient refusal to give consent&#xD;
&#xD;
          -  inability to give consent&#xD;
&#xD;
          -  age ≤18 years&#xD;
&#xD;
          -  ASA ≥ IV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>azienda ospedaliero universitaria Sant'Andrea</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Silvia Fiorelli</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <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/NCT03805880
org study id: SATURIMETRIA
nct id: NCT03805880
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study prospective observational study is to determine cognitive
      dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral
      oxygen desaturations and hypertension as risk factors for post-operative cognitive
      dysfunction (POCD) in patients undergoing lung resection.
observational model: Cohort
time perspective: Prospective
measure: incidence of cognitive dysfunction after thoracic surgery
time frame: change of MMSE score from the day before surgery (baseline) at 1 day after surgery
description: A decrease in Mini-Mental State Examination (MMSE) score > 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)
measure: role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.
time frame: change of cerebral saturation from baseline(before surgery) at intraoperative measure
description: monitoring values of cerebral saturation during intraoperative period:Cerebral desaturation was defined as a reduction of rSO2 during OLV of more than 20% from the baseline value
measure: role of hypertension as risk factors for POCD in patients undergoing lung resection.
time frame: change of blood pressure from baseline(before surgery) at intraoperative measure
description: monitoring values of blood pressure during intraoperative period
intervention type: Diagnostic Test
intervention name: cerebral desaturation monitoring and cognitive examination
description: Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Silvia Fiorelli
investigator title: principal investigator
mesh term: Cognitive Dysfunction
sharing ipd: No