xml: <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/NCT05961917</url>
    </required_header>
    <id_info>
      <org_study_id>NIRS</org_study_id>
      <nct_id>NCT05961917</nct_id>
    </id_info>
    <brief_title>Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation</brief_title>
    <official_title>Evaluation of the Effect of Different PEEP Levels on Regional Cerebral Oxygen Saturation in Patients Undergoing Elective Craniotomy for Excision of Brain Tumors ; Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bozyaka Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bozyaka Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this prospective single-blind randomized clinical trial is to compare the effect&#xD;
        of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen&#xD;
        saturation in patients scheduled for craniotomy due to supratentorial masses.&#xD;
  &#xD;
        The main question it aims to answer is that how high PEEP level effects the regional cerebral&#xD;
        oxygen saturation in patients with high intracranial pressure due to mass effect. Patients&#xD;
        will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O).&#xD;
        Researchers will compare the changes of regional cerebral oxygen saturations between two&#xD;
        groups by near infra-red spectroscopy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this prospective single-blind study, American Society of Anesthesiologists physical status&#xD;
        classification system (ASA) I and II patients aged older than 18 years undergoing craniotomy&#xD;
        will be enrolled for the study. Patients will be divided into two groups with computer-based&#xD;
        randomization technique. Written and verbal approval will be taken from all patients.&#xD;
        Premedication will not be used. Patients will be monitorized by standard non-invasive&#xD;
        monitorization (electrocardiography, non-invasive blood pressure measurement, peripheral&#xD;
        oxygen saturation) in the operating room. Cerebral/somatic oximeter, near infra-red&#xD;
        spectroscopy (NIRS) sensor will be placed on the frontotemporal area and regional cerebral&#xD;
        oxygen saturation will be monitorized continuously. Remifentanil infusion with a dose of 0.25&#xD;
        mcg/kg/min will be started two minutes before the induction. After preoxygenation with 6&#xD;
        L/min oxygen for 5 minutes, general anesthesia induction for patients in both groups will be&#xD;
        held with intravenous 2 mg/kg propofol. Rocuronium bromide (0.6 mg/kg) will be used for&#xD;
        muscle relaxation. Endotracheal intubation will be performed. Controlled mechanical&#xD;
        ventilation will be used during the surgery. Invasive arterial blood pressure monitorization&#xD;
        will be done and a central venous catheter will be placed in both groups.&#xD;
  &#xD;
        In group low PEEP, the patients' settings of mechanical ventilation will be as tidal volume&#xD;
        6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 5 cmH2O. Frequency will be set according&#xD;
        to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.&#xD;
  &#xD;
        In group high PEEP, the patients' settings of mechanical ventilation will be as tidal volume&#xD;
        6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 10 cmH2O. Frequency will be set&#xD;
        according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.&#xD;
  &#xD;
        Remifentanil with a dose of 0.05-2 mcg kg/min and propofol with a dose of 50-200 mcg/kg/min&#xD;
        will be infused for general anesthesia maintenance in both groups. Dose of remifentanil&#xD;
        infusion will be changed according to the blood pressure. If the mean arterial blood pressure&#xD;
        and/or heart rate will decrease to 20% of the baseline mean arterial blood pressure and heart&#xD;
        rate, the infusion dose will be lowered. If this decrease in heart rate will be over 25%,&#xD;
        intravenous 0.5 mg atropin will be administered. If the mean arterial blood pressure will be&#xD;
        under 55 mmHg, intravenous 5 mg ephedrine will be administered. If the mean arterial blood&#xD;
        pressure will continue to decrease, PEEP will be lowered. If the peripheral oxygen saturation&#xD;
        will be under 92%, the inspired oxygen fraction or PEEP will be increased. In these&#xD;
        conditions, the patient will be out of study.&#xD;
  &#xD;
        1 gr paracetamol will be given intravenously for pain relief. Sugammadex will be used with a&#xD;
        dose of 4 mg/kg for extubation.&#xD;
  &#xD;
        Regional cerebral oxygen saturation measures will be recorded nine (9) times during the&#xD;
        study; pre-induction (period 1), post-induction (period 2), skull pinning (period 3), before&#xD;
        dura opening (period 4), after dura opening (period 5), surgical resection of the mass&#xD;
        (period 6), dura closure (period 7), end of the surgery (period 8) and end of anesthesia&#xD;
        (period 9).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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>Screening</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 1</measure>
      <time_frame>Pre-induction</time_frame>
      <description>The measurement of regional cerebral oxygen saturation before anesthesia induction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 2</measure>
      <time_frame>Up to 5 minutes after anethesia induction</time_frame>
      <description>The measurement of regional cerebral oxygen saturation after anesthesia induction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 3</measure>
      <time_frame>From skull-pinning to final head position</time_frame>
      <description>The measurement of regional cerebral oxygen saturation during skull pinning</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 4</measure>
      <time_frame>Just before dura opening</time_frame>
      <description>The measurement of regional cerebral oxygen saturation before dura opening</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 5</measure>
      <time_frame>Up to 5 minutes of dura opening</time_frame>
      <description>The measurement of regional cerebral oxygen saturation after dura opening</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 6</measure>
      <time_frame>During surgical resection</time_frame>
      <description>The measurement of regional cerebral oxygen saturation during surgical resection of the mass</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 7</measure>
      <time_frame>Up to 5 minutes of dura closure</time_frame>
      <description>The measurement of regional cerebral oxygen saturation after dura closure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 8</measure>
      <time_frame>Within 5 minutes after the surgery</time_frame>
      <description>The measurement of regional cerebral oxygen saturation at the end of surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regional cerebral oxygen saturation (SrO2) period 9</measure>
      <time_frame>Within 5 minutes after end of anesthesia</time_frame>
      <description>The measurement of regional cerebral oxygen saturation at the end of anesthesia</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Regional Cerebral Oxygen Saturation</condition>
    <arm_group>
      <arm_group_label>Group low PEEP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group high PEEP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>5 cmH2O Positive end-expiratory pressure (PEEP)</intervention_name>
      <description>PEEP will be set at 5 cmH2O</description>
      <arm_group_label>Group low PEEP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>10 cmH2O Positive end-expiratory pressure (PEEP)</intervention_name>
      <description>PEEP will be set at 10 cmH2O</description>
      <arm_group_label>Group high PEEP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Older than 18 years&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status classification system (ASA) I&#xD;
               and II&#xD;
  &#xD;
            -  Patients scheduled for elective craniotomy&#xD;
  &#xD;
            -  Patients with supratentorial mass&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hemoglobin concentration lower than 9 mg/dL&#xD;
  &#xD;
            -  Uncontrolled hypertension&#xD;
  &#xD;
            -  Congestive heart failure&#xD;
  &#xD;
            -  Severe chronic obstructive lung disease&#xD;
  &#xD;
            -  Cerebrovascular disease&#xD;
  &#xD;
            -  Pulmonary edema&#xD;
  &#xD;
            -  History of carotis surgery or stenosis of carotid artery&#xD;
  &#xD;
            -  Unstable hemodynamics&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Skin reaction to the NIRS sensor&#xD;
  &#xD;
            -  Patient's refusal&#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>Halide H Şahinkaya, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Health Sciences İzmir Bozyaka Education and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Çağlar Ayar, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Health Sciences İzmir Bozyaka Education and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alper Tabanlı, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Health Sciences İzmir Bozyaka Education and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Zeki T Tekgül, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Health Sciences İzmir Bozyaka Education and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Halide H Şahinkaya, MD</last_name>
      <phone>+905058892157</phone>
      <email>drhhande@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Health Sciences İzmir Bozyaka Education and Research Hospital</name>
        <address>
          <city>İzmir</city>
          <state>Bozyaka</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Halide H Şahinkaya, MD</last_name>
        <phone>+905058892157</phone>
        <email>drhhande@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.</citation>
      <PMID>26099617</PMID>
    </reference>
    <reference>
      <citation>Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.</citation>
      <PMID>34823465</PMID>
    </reference>
    <reference>
      <citation>Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.</citation>
      <PMID>19660190</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bozyaka Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Halide Hande Şahinkaya</investigator_full_name>
      <investigator_title>MD, Anesthesiology Specialist, Clinical Director</investigator_title>
    </responsible_party>
    <keyword>regional cerebral oxygen saturation</keyword>
    <keyword>PEEP</keyword>
    <keyword>craniotomy</keyword>
    <keyword>near-infrared spectroscopy</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961917
  org study id: NIRS
  nct id: NCT05961917
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective single-blind randomized clinical trial is to compare the effect
        of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen
        saturation in patients scheduled for craniotomy due to supratentorial masses.
  
        The main question it aims to answer is that how high PEEP level effects the regional cerebral
        oxygen saturation in patients with high intracranial pressure due to mass effect. Patients
        will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O).
        Researchers will compare the changes of regional cerebral oxygen saturations between two
        groups by near infra-red spectroscopy.
  In this prospective single-blind study, American Society of Anesthesiologists physical status
        classification system (ASA) I and II patients aged older than 18 years undergoing craniotomy
        will be enrolled for the study. Patients will be divided into two groups with computer-based
        randomization technique. Written and verbal approval will be taken from all patients.
        Premedication will not be used. Patients will be monitorized by standard non-invasive
        monitorization (electrocardiography, non-invasive blood pressure measurement, peripheral
        oxygen saturation) in the operating room. Cerebral/somatic oximeter, near infra-red
        spectroscopy (NIRS) sensor will be placed on the frontotemporal area and regional cerebral
        oxygen saturation will be monitorized continuously. Remifentanil infusion with a dose of 0.25
        mcg/kg/min will be started two minutes before the induction. After preoxygenation with 6
        L/min oxygen for 5 minutes, general anesthesia induction for patients in both groups will be
        held with intravenous 2 mg/kg propofol. Rocuronium bromide (0.6 mg/kg) will be used for
        muscle relaxation. Endotracheal intubation will be performed. Controlled mechanical
        ventilation will be used during the surgery. Invasive arterial blood pressure monitorization
        will be done and a central venous catheter will be placed in both groups.
  
        In group low PEEP, the patients' settings of mechanical ventilation will be as tidal volume
        6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 5 cmH2O. Frequency will be set according
        to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
  
        In group high PEEP, the patients' settings of mechanical ventilation will be as tidal volume
        6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 10 cmH2O. Frequency will be set
        according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
  
        Remifentanil with a dose of 0.05-2 mcg kg/min and propofol with a dose of 50-200 mcg/kg/min
        will be infused for general anesthesia maintenance in both groups. Dose of remifentanil
        infusion will be changed according to the blood pressure. If the mean arterial blood pressure
        and/or heart rate will decrease to 20% of the baseline mean arterial blood pressure and heart
        rate, the infusion dose will be lowered. If this decrease in heart rate will be over 25%,
        intravenous 0.5 mg atropin will be administered. If the mean arterial blood pressure will be
        under 55 mmHg, intravenous 5 mg ephedrine will be administered. If the mean arterial blood
        pressure will continue to decrease, PEEP will be lowered. If the peripheral oxygen saturation
        will be under 92%, the inspired oxygen fraction or PEEP will be increased. In these
        conditions, the patient will be out of study.
  
        1 gr paracetamol will be given intravenously for pain relief. Sugammadex will be used with a
        dose of 4 mg/kg for extubation.
  
        Regional cerebral oxygen saturation measures will be recorded nine (9) times during the
        study; pre-induction (period 1), post-induction (period 2), skull pinning (period 3), before
        dura opening (period 4), after dura opening (period 5), surgical resection of the mass
        (period 6), dura closure (period 7), end of the surgery (period 8) and end of anesthesia
        (period 9).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: Single (Participant)
  measure: regional cerebral oxygen saturation (SrO2) period 1
  time frame: Pre-induction
  description: The measurement of regional cerebral oxygen saturation before anesthesia induction
  measure: regional cerebral oxygen saturation (SrO2) period 2
  time frame: Up to 5 minutes after anethesia induction
  description: The measurement of regional cerebral oxygen saturation after anesthesia induction
  measure: regional cerebral oxygen saturation (SrO2) period 3
  time frame: From skull-pinning to final head position
  description: The measurement of regional cerebral oxygen saturation during skull pinning
  measure: regional cerebral oxygen saturation (SrO2) period 4
  time frame: Just before dura opening
  description: The measurement of regional cerebral oxygen saturation before dura opening
  measure: regional cerebral oxygen saturation (SrO2) period 5
  time frame: Up to 5 minutes of dura opening
  description: The measurement of regional cerebral oxygen saturation after dura opening
  measure: regional cerebral oxygen saturation (SrO2) period 6
  time frame: During surgical resection
  description: The measurement of regional cerebral oxygen saturation during surgical resection of the mass
  measure: regional cerebral oxygen saturation (SrO2) period 7
  time frame: Up to 5 minutes of dura closure
  description: The measurement of regional cerebral oxygen saturation after dura closure
  measure: regional cerebral oxygen saturation (SrO2) period 8
  time frame: Within 5 minutes after the surgery
  description: The measurement of regional cerebral oxygen saturation at the end of surgery
  measure: regional cerebral oxygen saturation (SrO2) period 9
  time frame: Within 5 minutes after end of anesthesia
  description: The measurement of regional cerebral oxygen saturation at the end of anesthesia
  arm group label: Group low PEEP
  arm group type: Active Comparator
  description: Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.
  arm group label: Group high PEEP
  arm group type: Active Comparator
  description: Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.
  intervention type: Other
  intervention name: 5 cmH2O Positive end-expiratory pressure (PEEP)
  description: PEEP will be set at 5 cmH2O
  arm group label: Group low PEEP
  intervention type: Other
  intervention name: 10 cmH2O Positive end-expiratory pressure (PEEP)
  description: PEEP will be set at 10 cmH2O
  arm group label: Group high PEEP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Halide H Şahinkaya, MD
  role: Study Chair
  affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
  last name: Çağlar Ayar, MD
  role: Study Chair
  affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
  last name: Alper Tabanlı, MD
  role: Study Chair
  affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
  last name: Zeki T Tekgül, MD
  role: Study Chair
  affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
  last name: Halide H Şahinkaya, MD
  phone: +905058892157
  email: drhhande@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.
  PMID: 26099617
  citation: Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.
  PMID: 34823465
  citation: Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.
  PMID: 19660190
  responsible party type: Principal Investigator
  investigator affiliation: Bozyaka Training and Research Hospital
  investigator full name: Halide Hande Şahinkaya
  investigator title: MD, Anesthesiology Specialist, Clinical Director