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/NCT05992636</url>
    </required_header>
    <id_info>
      <org_study_id>Karadeniz Teknik Üniversitesi</org_study_id>
      <nct_id>NCT05992636</nct_id>
    </id_info>
    <brief_title>Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy</brief_title>
    <official_title>The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karadeniz Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karadeniz Technical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created&#xD;
        by different insufflation flows are very limited in the literature. In a current literature&#xD;
        review, there was no study found comparing the effects of hemodynamic changes created by low&#xD;
        and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The&#xD;
        purpose of the study was to contribute to the literature by investigating the effects of&#xD;
        pneumoperitoneum pressures created by different flows on brain oxygenation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would&#xD;
        undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34&#xD;
        (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and&#xD;
        high insufflation flow (40 lt/min) with pneumoperitoneum pressure.&#xD;
  &#xD;
        The study will be conducted as a single-center observational study in Trabzon KTU Faculty of&#xD;
        Medicine General Surgery Operating Room. Anesthesia always be performed by the same&#xD;
        anesthesia team, and no intervention will be made regarding the choice of the method. The&#xD;
        data obtained will be recorded by the anesthetists other than the team who constitute the&#xD;
        study group, and the data obtained at the end of the surgery will be interpreted by the study&#xD;
        team. The decision for laparoscopic cholecystectomy of the patients who will be included in&#xD;
        the study will be made by the General Surgery doctor, and the patients who are scheduled to&#xD;
        be operated on electively will be included in the study.&#xD;
  &#xD;
        The patients will be taken to the operating room after their written consents are obtained&#xD;
        and preoperative evaluations are made, and routine premedication will be applied to the&#xD;
        patients who arrive at the operating room. The patients who will be included in the study&#xD;
        will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG),&#xD;
        non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index&#xD;
        (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in&#xD;
        which patients who will undergo general anesthesia will be in the pneumoperitoneum group&#xD;
        formed with low insufflation flow or high insufflation flow, only non-invasive cerebral&#xD;
        oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic&#xD;
        Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 19, 2021</start_date>
    <completion_date type="Actual">June 20, 2022</completion_date>
    <primary_completion_date type="Actual">April 23, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>the relationship between insufflation flow rate and cerebral desaturation (rSO2)</measure>
      <time_frame>8 months</time_frame>
      <description>With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS).&#xD;
  The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)</measure>
      <time_frame>8 months</time_frame>
      <description>Relationship between insufflation flow rate and end-tidal carbon dioxide value variation of the patients according to basal and before-pnömoperitoneum end-tidal carbon dioxide levels (mmHg) was determined with capnographic measurements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the relationship between insufflation flow rate and heart rate value variation (beats per minute)</measure>
      <time_frame>8 months</time_frame>
      <description>Relationship between insufflation flow rate and heart rate value variation of the patients according to basal and before-pnömoperitoneum heart rate levels was determined with pulse monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)</measure>
      <time_frame>8 months</time_frame>
      <description>Relationship between insufflation flow rate and systolic, diastolic and mean arterial pressure (mmHg) values variation of the patients according to basal and before-pnömoperitoneum systolic, diastolic and mean arterial pressure levels were determined with non-invasive blood pressure measurements.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">69</enrollment>
    <condition>Pneumoperitoneum</condition>
    <arm_group>
      <arm_group_label>low insufflation flow (10 lt/min)</arm_group_label>
      <description>Patiens who perform pneumoperitoneum with low insufflation flow (10 lt/min)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high insufflation flow (40 lt/min)</arm_group_label>
      <description>Patiens who perform pneumoperitoneum with high insufflation flow (40 lt/min)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pneumoperitoneum insufflation (flow) rate</intervention_name>
      <description>Patiens who initiate with low insufflation flow (10 lt/min)&#xD;
  Patiens who initiate with high insufflation flow (40 lt/min)</description>
      <arm_group_label>high insufflation flow (40 lt/min)</arm_group_label>
      <arm_group_label>low insufflation flow (10 lt/min)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          After the approval of the Ethics Committee, a total of 69 (sixty) patients who would&#xD;
          undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old,&#xD;
          34 (thirty-four) patients with low insufflation flow (10 lt/min), and 35 (thirty-five)&#xD;
          patients in high insufflation flow (40 lt/min) with pneumoperitoneum pressure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  elective laparoscopic cholecystectomy were planned,&#xD;
  &#xD;
            -  ASA I-III,&#xD;
  &#xD;
            -  18-65 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cerebrovascular diseases and/or intracranial pathologies and/or related neurological&#xD;
               events,&#xD;
  &#xD;
            -  Uncontrolled diabetes&#xD;
  &#xD;
            -  Uncontrolled hypertension&#xD;
  &#xD;
            -  Coagulopathy,&#xD;
  &#xD;
            -  Cirrhosis and/or peritonitis,&#xD;
  &#xD;
            -  Asthma and/or respiratory diseases e.g. COPD,&#xD;
  &#xD;
            -  Morbid obesity,&#xD;
  &#xD;
            -  Patients with severe organ failure,&#xD;
  &#xD;
            -  Emergency cases,&#xD;
  &#xD;
            -  Cases converted to laparotomic cholecystectomy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>KIVANÇ ÖNCÜ, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Karadeniz Technical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Karadeniz Technical University</name>
        <address>
          <city>Trabzon</city>
          <zip>61080</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 12, 2021</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
      <investigator_full_name>SEDAT SAYLAN</investigator_full_name>
      <investigator_title>Associate Prof.</investigator_title>
    </responsible_party>
    <keyword>laparoscopic cholecystectomy</keyword>
    <keyword>Near Infrared Spectroscopy (NIRS)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumoperitoneum</mesh_term>
    </condition_browse>
    <!-- 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/NCT05992636
  org study id: Karadeniz Teknik Üniversitesi
  nct id: NCT05992636
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created
        by different insufflation flows are very limited in the literature. In a current literature
        review, there was no study found comparing the effects of hemodynamic changes created by low
        and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The
        purpose of the study was to contribute to the literature by investigating the effects of
        pneumoperitoneum pressures created by different flows on brain oxygenation.
  After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would
        undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34
        (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and
        high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
  
        The study will be conducted as a single-center observational study in Trabzon KTU Faculty of
        Medicine General Surgery Operating Room. Anesthesia always be performed by the same
        anesthesia team, and no intervention will be made regarding the choice of the method. The
        data obtained will be recorded by the anesthetists other than the team who constitute the
        study group, and the data obtained at the end of the surgery will be interpreted by the study
        team. The decision for laparoscopic cholecystectomy of the patients who will be included in
        the study will be made by the General Surgery doctor, and the patients who are scheduled to
        be operated on electively will be included in the study.
  
        The patients will be taken to the operating room after their written consents are obtained
        and preoperative evaluations are made, and routine premedication will be applied to the
        patients who arrive at the operating room. The patients who will be included in the study
        will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG),
        non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index
        (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in
        which patients who will undergo general anesthesia will be in the pneumoperitoneum group
        formed with low insufflation flow or high insufflation flow, only non-invasive cerebral
        oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic
        Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)
  observational model: Case-Control
  time perspective: Prospective
  measure: the relationship between insufflation flow rate and cerebral desaturation (rSO2)
  time frame: 8 months
  description: With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS).
  The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )
  measure: the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)
  time frame: 8 months
  description: Relationship between insufflation flow rate and end-tidal carbon dioxide value variation of the patients according to basal and before-pnömoperitoneum end-tidal carbon dioxide levels (mmHg) was determined with capnographic measurements.
  measure: the relationship between insufflation flow rate and heart rate value variation (beats per minute)
  time frame: 8 months
  description: Relationship between insufflation flow rate and heart rate value variation of the patients according to basal and before-pnömoperitoneum heart rate levels was determined with pulse monitoring.
  measure: the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)
  time frame: 8 months
  description: Relationship between insufflation flow rate and systolic, diastolic and mean arterial pressure (mmHg) values variation of the patients according to basal and before-pnömoperitoneum systolic, diastolic and mean arterial pressure levels were determined with non-invasive blood pressure measurements.
  arm group label: low insufflation flow (10 lt/min)
  description: Patiens who perform pneumoperitoneum with low insufflation flow (10 lt/min)
  arm group label: high insufflation flow (40 lt/min)
  description: Patiens who perform pneumoperitoneum with high insufflation flow (40 lt/min)
  intervention type: Procedure
  intervention name: pneumoperitoneum insufflation (flow) rate
  description: Patiens who initiate with low insufflation flow (10 lt/min)
  Patiens who initiate with high insufflation flow (40 lt/min)
  arm group label: high insufflation flow (40 lt/min)
  arm group label: low insufflation flow (10 lt/min)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: KIVANÇ ÖNCÜ, M.D.
  role: Study Chair
  affiliation: Karadeniz Technical University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Karadeniz Technical University
  investigator full name: SEDAT SAYLAN
  investigator title: Associate Prof.
  mesh term: Pneumoperitoneum