<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/NCT02991976</url>
  </required_header>
  <id_info>
    <org_study_id>OsijekUH4</org_study_id>
    <nct_id>NCT02991976</nct_id>
  </id_info>
  <brief_title>Oxygen Concentration and Recovery After Carotid Endarterectomy</brief_title>
  <official_title>Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osijek University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Osijek University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and&#xD;
      patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid&#xD;
      with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High inspired oxygen concentration may reduce brain hypoxia in the patients undergoing&#xD;
      carotid endarterectomy with total intravenous anaesthesia. However, there are some studies&#xD;
      suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. This&#xD;
      study was performed to measure the influence of fraction of inspired oxygen (FiO2) on the&#xD;
      regional tissue oxygenation in the patients undergoing carotid endarterectomy with total&#xD;
      intravenous anaesthesia. The INVOS 5100B monitor was used for regional cerebral oxygen&#xD;
      saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool&#xD;
      (Covidien) for area under curve (AUC) calculations. A bispectral index and invasive blood&#xD;
      pressure monitoring were used in all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under curve of regional cerebral oxygen saturation (rSO2) curve</measure>
    <time_frame>During surgery</time_frame>
    <description>Intraoperative high oxygen concentrations may reduce intensity of tissue hypoxic episodes during carotid endarterectomy in total intravenous anesthesia (TIVA).&#xD;
The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for Area under curve (AUC) calculations. Data were analyzed using two sided T-test and Fisher exact test. A P&lt;0.05 was considered as statistically significant Postoperative follow up in large patient's group is necessary to confirm its impact on patients' outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early neurologic recovery, TIA or brain ischemia</measure>
    <time_frame>Till 7 days after surgery</time_frame>
    <description>Postoperative patient follow up by clinical signs or CT scan confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit admission, Death</measure>
    <time_frame>Till 7 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hypoxia-Ischemia, Brain</condition>
  <condition>Ischemia, Vertebral Artery</condition>
  <condition>Artery Stenosis, Carotid</condition>
  <arm_group>
    <arm_group_label>35% O2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100% O2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oxygen concentration</intervention_name>
    <description>Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)</description>
    <arm_group_label>100% O2</arm_group_label>
    <arm_group_label>35% O2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient undergoing surgery (carotid endarterectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction&#xD;
             suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis&#xD;
             to drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>slavica kvolik, prof.</last_name>
    <role>Study Director</role>
    <affiliation>Osijek Hospital University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osijek Hospital University</name>
      <address>
        <city>Osijek</city>
        <state>Osjecko - baranjska</state>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <reference>
    <citation>Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.</citation>
    <PMID>23510092</PMID>
  </reference>
  <results_reference>
    <citation>Picton P, Chambers J, Shanks A, Dorje P. The influence of inspired oxygen fraction and end-tidal carbon dioxide on post-cross-clamp cerebral oxygenation during carotid endarterectomy under general anesthesia. Anesth Analg. 2010 Feb 1;110(2):581-7. doi: 10.1213/ANE.0b013e3181c5f160. Epub 2009 Dec 2.</citation>
    <PMID>19955500</PMID>
  </results_reference>
  <results_reference>
    <citation>Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.</citation>
    <PMID>24672486</PMID>
  </results_reference>
  <results_reference>
    <citation>Rokamp KZ, Secher NH, Eiberg J, Lonn L, Nielsen HB. O2 supplementation to secure the near-infrared spectroscopy determined brain and muscle oxygenation in vascular surgical patients: a presentation of 100 cases. Front Physiol. 2014 Feb 25;5:66. doi: 10.3389/fphys.2014.00066. eCollection 2014.</citation>
    <PMID>24611051</PMID>
  </results_reference>
  <results_reference>
    <citation>Hojlund J, Sandmand M, Sonne M, Mantoni T, Jorgensen HL, Belhage B, van Lieshout JJ, Pott FC. Effect of head rotation on cerebral blood velocity in the prone position. Anesthesiol Res Pract. 2012;2012:647258. doi: 10.1155/2012/647258. Epub 2012 Sep 5.</citation>
    <PMID>22988456</PMID>
  </results_reference>
  <results_reference>
    <citation>Wolff CB. Oxygen delivery: the principal role of the circulation. Adv Exp Med Biol. 2013;789:37-42. doi: 10.1007/978-1-4614-7411-1_6.</citation>
    <PMID>23852474</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Osijek University Hospital</investigator_affiliation>
    <investigator_full_name>Vedran Gašić, MD</investigator_full_name>
    <investigator_title>Vedran Gasic, M.D.</investigator_title>
  </responsible_party>
  <keyword>Normobaric hyperoxia</keyword>
  <keyword>Cerebral oxygenation</keyword>
  <keyword>Near-infrared spectroscopy</keyword>
  <keyword>Carotid endarterectomy</keyword>
  <keyword>TIVA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Vertebrobasilar Insufficiency</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02991976
org study id: OsijekUH4
nct id: NCT02991976
lead sponsor: 
has dmc: No
This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and
      patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid
      with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.
High inspired oxygen concentration may reduce brain hypoxia in the patients undergoing
      carotid endarterectomy with total intravenous anaesthesia. However, there are some studies
      suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. This
      study was performed to measure the influence of fraction of inspired oxygen (FiO2) on the
      regional tissue oxygenation in the patients undergoing carotid endarterectomy with total
      intravenous anaesthesia. The INVOS 5100B monitor was used for regional cerebral oxygen
      saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool
      (Covidien) for area under curve (AUC) calculations. A bispectral index and invasive blood
      pressure monitoring were used in all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Area under curve of regional cerebral oxygen saturation (rSO2) curve
time frame: During surgery
description: Intraoperative high oxygen concentrations may reduce intensity of tissue hypoxic episodes during carotid endarterectomy in total intravenous anesthesia (TIVA).
The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for Area under curve (AUC) calculations. Data were analyzed using two sided T-test and Fisher exact test. A P<0.05 was considered as statistically significant Postoperative follow up in large patient's group is necessary to confirm its impact on patients' outcome.
measure: Early neurologic recovery, TIA or brain ischemia
time frame: Till 7 days after surgery
description: Postoperative patient follow up by clinical signs or CT scan confirmation
measure: Intensive Care Unit admission, Death
time frame: Till 7 days after surgery
arm group label: 35% O2
arm group type: Active Comparator
description: Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
arm group label: 100% O2
arm group type: Active Comparator
description: Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
intervention type: Procedure
intervention name: Oxygen concentration
description: Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)
arm group label: 100% O2
arm group label: 35% O2
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: slavica kvolik, prof.
role: Study Director
affiliation: Osijek Hospital University
facility: 
country: Croatia
citation: Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
PMID: 23510092
citation: Picton P, Chambers J, Shanks A, Dorje P. The influence of inspired oxygen fraction and end-tidal carbon dioxide on post-cross-clamp cerebral oxygenation during carotid endarterectomy under general anesthesia. Anesth Analg. 2010 Feb 1;110(2):581-7. doi: 10.1213/ANE.0b013e3181c5f160. Epub 2009 Dec 2.
PMID: 19955500
citation: Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.
PMID: 24672486
citation: Rokamp KZ, Secher NH, Eiberg J, Lonn L, Nielsen HB. O2 supplementation to secure the near-infrared spectroscopy determined brain and muscle oxygenation in vascular surgical patients: a presentation of 100 cases. Front Physiol. 2014 Feb 25;5:66. doi: 10.3389/fphys.2014.00066. eCollection 2014.
PMID: 24611051
citation: Hojlund J, Sandmand M, Sonne M, Mantoni T, Jorgensen HL, Belhage B, van Lieshout JJ, Pott FC. Effect of head rotation on cerebral blood velocity in the prone position. Anesthesiol Res Pract. 2012;2012:647258. doi: 10.1155/2012/647258. Epub 2012 Sep 5.
PMID: 22988456
citation: Wolff CB. Oxygen delivery: the principal role of the circulation. Adv Exp Med Biol. 2013;789:37-42. doi: 10.1007/978-1-4614-7411-1_6.
PMID: 23852474
responsible party type: Principal Investigator
investigator affiliation: Osijek University Hospital
investigator full name: Vedran Gašić, MD
investigator title: Vedran Gasic, M.D.
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Carotid Stenosis
mesh term: Vertebrobasilar Insufficiency
mesh term: Ischemia
mesh term: Hypoxia
sharing ipd: Undecided