<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/NCT04413903</url>
  </required_header>
  <id_info>
    <org_study_id>2017-17/23</org_study_id>
    <nct_id>NCT04413903</nct_id>
  </id_info>
  <brief_title>the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions</brief_title>
  <official_title>The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bursa Yüksek İhtisas Education and Research Hospital</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>
      During surgery, researchers use different methods in respiratory equipment. In the study&#xD;
      researchers examine the effects of these methods on intraocular pressure changes by looking&#xD;
      at the intraocular nerve diameter. Then look at the effects of these effects on patients&#xD;
      conscious functions by asking some questions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the mechanical ventilator application to be applied to the patients; Group P (n:&#xD;
      30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation&#xD;
      (VCV) are randomly assigned to two groups. General anesthesia will be applied to all&#xD;
      patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume).&#xD;
      Demographic data (age, gender, weight, height) of patients, duration of surgery and&#xD;
      peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min&#xD;
      after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is&#xD;
      reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2,&#xD;
      Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function&#xD;
      test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT&#xD;
      (Mini Mental Status Detection) scale. The same test will be repeated for patients who are&#xD;
      called for routine general surgery outpatient control 3 months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>
    <intervention_model_description>ASA I-II 60 patients aged 18-65 years undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled 50% air, PEEP 5 to 8ml / kg tidal volume.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optic nerve sheath diameter (milimeter)</measure>
    <time_frame>2 hours operation time</time_frame>
    <description>Optic nerve sheath diameter; It was measured from the optic nerve sheath 3 mm behind the optic disc from the closed upper eyelid. T0: Awake, T1: 5th minute after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4: Before extubation in supine position. A typical optic nerve sheath is generally less than 5 mm in diameter and diameters greater than 5.5 mm predict an ICP of &gt;20 cmH2O .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Function</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Cognitive function test with Mini Mental Conditioning Scale was performed to the patients before the anesthesia induction and 3 months after the surgery . Mini Mental Scale points are between 0 and 30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peroperative Complications</measure>
    <time_frame>2 hours operation time</time_frame>
    <description>Complications during the surgery (hypercapnia, hypotension,hypertension,rythm disorder) were recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Pressure controlled ventilation, Volum controlled ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled ventilation settings were adjusted to be 50% O2- 50% air, 8ml / kg TV (tidal volume) and PEEP 5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optic Nerve Sheath Diameter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In optic nerve diameter measurements; A layer of water-soluble sterile gel was applied to the closed upper eyelid. The linear 10-5 MHz ultrasound probe was carefully placed on the upper eyelid over the gel. The entrance of the optic nerve to the orbital globe in 2D mode was displayed on the monitor without applying too much pressure. After finding the optimal contrast between the retrobulbar echogenic fat tissue and vertical hypoechoic band 23, the diameter of the optic nerve sheath was measured 3 mm behind the optic disc using an electronic caliper.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations</intervention_name>
    <description>The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations</description>
    <arm_group_label>Optic Nerve Sheath Diameter</arm_group_label>
    <arm_group_label>Pressure controlled ventilation, Volum controlled ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to cooperate&#xD;
&#xD;
          -  Presence of eye disease (detachment, retinapathy, glaucoma)&#xD;
&#xD;
          -  Presence of a previous eye operation&#xD;
&#xD;
          -  Those with symptoms of KIBAS (intracranial pressure increase syndrome) (Intracranial&#xD;
             lesion, previous cerebrovascular diseases)&#xD;
&#xD;
          -  BMI (body mass index&gt; 40 kg / m2&#xD;
&#xD;
          -  Obstructive and restrictive lung disease&#xD;
&#xD;
          -  Pulmonary Hypertension&#xD;
&#xD;
          -  Congestive Heart Failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tugba Onur, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BYIEAH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Korgun Okmen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BYIEAH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Serkan Terkancıoglu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BYIEAH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gorkem Cevik, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BYIEAH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital</name>
      <address>
        <city>Bursa</city>
        <zip>60160</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Umran Karaca</investigator_full_name>
    <investigator_title>Principle İnvestigator</investigator_title>
  </responsible_party>
  <keyword>Optic Nerve Sheath Diameter,</keyword>
  <keyword>Minimental test</keyword>
  <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/NCT04413903
org study id: 2017-17/23
nct id: NCT04413903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During surgery, researchers use different methods in respiratory equipment. In the study
      researchers examine the effects of these methods on intraocular pressure changes by looking
      at the intraocular nerve diameter. Then look at the effects of these effects on patients
      conscious functions by asking some questions.
According to the mechanical ventilator application to be applied to the patients; Group P (n:
      30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation
      (VCV) are randomly assigned to two groups. General anesthesia will be applied to all
      patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume).
      Demographic data (age, gender, weight, height) of patients, duration of surgery and
      peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min
      after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is
      reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2,
      Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function
      test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT
      (Mini Mental Status Detection) scale. The same test will be repeated for patients who are
      called for routine general surgery outpatient control 3 months after surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: ASA I-II 60 patients aged 18-65 years undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled 50% air, PEEP 5 to 8ml / kg tidal volume.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Optic nerve sheath diameter (milimeter)
time frame: 2 hours operation time
description: Optic nerve sheath diameter; It was measured from the optic nerve sheath 3 mm behind the optic disc from the closed upper eyelid. T0: Awake, T1: 5th minute after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4: Before extubation in supine position. A typical optic nerve sheath is generally less than 5 mm in diameter and diameters greater than 5.5 mm predict an ICP of >20 cmH2O .
measure: Cognitive Function
time frame: 3 months after surgery
description: Cognitive function test with Mini Mental Conditioning Scale was performed to the patients before the anesthesia induction and 3 months after the surgery . Mini Mental Scale points are between 0 and 30.
measure: Peroperative Complications
time frame: 2 hours operation time
description: Complications during the surgery (hypercapnia, hypotension,hypertension,rythm disorder) were recorded.
arm group label: Pressure controlled ventilation, Volum controlled ventilation
arm group type: Active Comparator
description: Undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled ventilation settings were adjusted to be 50% O2- 50% air, 8ml / kg TV (tidal volume) and PEEP 5.
arm group label: Optic Nerve Sheath Diameter
arm group type: Active Comparator
description: In optic nerve diameter measurements; A layer of water-soluble sterile gel was applied to the closed upper eyelid. The linear 10-5 MHz ultrasound probe was carefully placed on the upper eyelid over the gel. The entrance of the optic nerve to the orbital globe in 2D mode was displayed on the monitor without applying too much pressure. After finding the optimal contrast between the retrobulbar echogenic fat tissue and vertical hypoechoic band 23, the diameter of the optic nerve sheath was measured 3 mm behind the optic disc using an electronic caliper.
intervention type: Procedure
intervention name: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
description: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
arm group label: Optic Nerve Sheath Diameter
arm group label: Pressure controlled ventilation, Volum controlled ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tugba Onur, MD
role: Study Chair
affiliation: BYIEAH
last name: Korgun Okmen, MD
role: Study Chair
affiliation: BYIEAH
last name: Serkan Terkancıoglu, MD
role: Study Chair
affiliation: BYIEAH
last name: Gorkem Cevik, MD
role: Study Chair
affiliation: BYIEAH
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
investigator full name: Umran Karaca
investigator title: Principle İnvestigator
sharing ipd: No