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/NCT05978310</url>
    </required_header>
    <id_info>
      <org_study_id>Trakya U/Anesthesiology</org_study_id>
      <nct_id>NCT05978310</nct_id>
    </id_info>
    <brief_title>NIRS and Anesthesiology</brief_title>
    <official_title>The Effect of Patient Position on Cerebral Regional Oxygen Saturation in Intracranial Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya University</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>
        Our aim in this study is to investigate the effects of the positions applied in Intracranial&#xD;
        Surgery on Cerebral Oxygenation(with NIRS device) and to evaluate the superiority of the&#xD;
        patient positions used to each other.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One of the main goals during anesthesia practice is to provide adequate tissue oxygenation.&#xD;
        For this purpose, many parameters such as ECG, blood pressure, blood gas, and urine&#xD;
        monitoring are monitored. However, it is a serious deficiency that the brain, which is the&#xD;
        most sensitive organ to ischemia, is not monitored in intracranial surgeries . Trying to keep&#xD;
        the intraoperative blood gas parameters and cerebral blood flow at normal values in order to&#xD;
        overcome this deficiency brings along serious problems in proportion to the frequency of the&#xD;
        measurement interval. For this reason, evaluation of tissue oxygenation with the Near&#xD;
        Infrared Spectroscopy (NIRS) method has come to the fore in recent years, and especially&#xD;
        cerebral regional oxygen saturation (rSo2) follow-ups have begun to be performed more&#xD;
        frequently. The values obtained by this method represent 75% venous, 20% arterial and 5%&#xD;
        capillary compartment of the measurement area .&#xD;
  &#xD;
        While deciding on the positions applied in intracranial surgery, it may be necessary to apply&#xD;
        modifications by keeping the surgical application site in the foreground. The preferred&#xD;
        patient position in the operation can help prevent complications and serious side effects.&#xD;
        Although each position applied in intracranial operations has advantages and disadvantages,&#xD;
        the surgeon should choose the most suitable position for the patient and pathology. The &quot;park&#xD;
        bench&quot; position is widely used in posterior fossa operations and has replaced the sitting&#xD;
        position for most neurosurgical procedures . However, since the advantages of the sitting&#xD;
        position could not be obtained, this position was also changed and the modified Park bench&#xD;
        position with 30 degrees upside tilt was used. This position can provide similar advantages&#xD;
        with the sitting position and also reduces the risk of venous air embolism and hypotension .&#xD;
        The modified sitting position for posterior fossa surgery versus the semi-sitting or &quot;beach&#xD;
        chair&quot; position retains many of the advantages and provides a rapid trendelenburg in case of&#xD;
        air embolism. The classical sitting position causes postural hypotension in approximately 1/3&#xD;
        of the patients and severe hypotension is seen in 2-5% of the patients. Excellent surgical&#xD;
        intervention, drier area and less blood loss, reduced facial swelling are the advantages of&#xD;
        the sitting position. However, the risk of venous air embolism and increased pneumocephalus&#xD;
        should not be ignored.&#xD;
  &#xD;
        In addition to the hemodynamic changes due to all these known positions, there is no&#xD;
        follow-up of cerebral regional oxygen saturation (rSo2) monitoring depending on the position,&#xD;
        which we could not detect in the literature. This monitoring can contribute to the optimal&#xD;
        continuation of cerebral blood flow while deciding on the appropriate position of the&#xD;
        patients. In this case, the postoperative mortality and morbidity of the patients can be&#xD;
        reduced. In addition, intraoperative cerebral oxygenation monitoring is critical for&#xD;
        predicting delirium in the postoperative period.&#xD;
  &#xD;
        Our aim in this study is to investigate the effects of the positions applied in Intracranial&#xD;
        Surgery on Cerebral Oxygenation and to evaluate the superiority of the patient positions used&#xD;
        to each other.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>NIRS values</measure>
      <time_frame>October 1, 2022 /February 1, 2025</time_frame>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>NIRS and Anesthesiology</condition>
    <arm_group>
      <arm_group_label>Group P</arm_group_label>
      <description>Patients operated in the prone position</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group S</arm_group_label>
      <description>Patients operated in the supine position</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group L</arm_group_label>
      <description>Patients operated in the lateral position</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          150 patients in the ASA I-II-III risk group between the ages of 25-75 who will undergo&#xD;
          intracranial surgery at Trakya University Medical Faculty Hospital will be included in the&#xD;
          study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who will undergo intracranial surgery&#xD;
  &#xD;
            -  Patients aged 25-75 years&#xD;
  &#xD;
            -  Patients in the ASA I-II-III risk group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a GCS below 15&#xD;
  &#xD;
            -  patients with heart failure, renal failure, liver failure&#xD;
  &#xD;
            -  patients with congenital neurological deficits&#xD;
  &#xD;
            -  patients who cannot be contacted&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Trakya university</name>
        <address>
          <city>Edirne</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trakya University</investigator_affiliation>
      <investigator_full_name>Ars Gor Dr Oguzhan Gulgen</investigator_full_name>
      <investigator_title>Research assistant doctor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05978310
  org study id: Trakya U/Anesthesiology
  nct id: NCT05978310
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our aim in this study is to investigate the effects of the positions applied in Intracranial
        Surgery on Cerebral Oxygenation(with NIRS device) and to evaluate the superiority of the
        patient positions used to each other.
  One of the main goals during anesthesia practice is to provide adequate tissue oxygenation.
        For this purpose, many parameters such as ECG, blood pressure, blood gas, and urine
        monitoring are monitored. However, it is a serious deficiency that the brain, which is the
        most sensitive organ to ischemia, is not monitored in intracranial surgeries . Trying to keep
        the intraoperative blood gas parameters and cerebral blood flow at normal values in order to
        overcome this deficiency brings along serious problems in proportion to the frequency of the
        measurement interval. For this reason, evaluation of tissue oxygenation with the Near
        Infrared Spectroscopy (NIRS) method has come to the fore in recent years, and especially
        cerebral regional oxygen saturation (rSo2) follow-ups have begun to be performed more
        frequently. The values obtained by this method represent 75% venous, 20% arterial and 5%
        capillary compartment of the measurement area .
  
        While deciding on the positions applied in intracranial surgery, it may be necessary to apply
        modifications by keeping the surgical application site in the foreground. The preferred
        patient position in the operation can help prevent complications and serious side effects.
        Although each position applied in intracranial operations has advantages and disadvantages,
        the surgeon should choose the most suitable position for the patient and pathology. The "park
        bench" position is widely used in posterior fossa operations and has replaced the sitting
        position for most neurosurgical procedures . However, since the advantages of the sitting
        position could not be obtained, this position was also changed and the modified Park bench
        position with 30 degrees upside tilt was used. This position can provide similar advantages
        with the sitting position and also reduces the risk of venous air embolism and hypotension .
        The modified sitting position for posterior fossa surgery versus the semi-sitting or "beach
        chair" position retains many of the advantages and provides a rapid trendelenburg in case of
        air embolism. The classical sitting position causes postural hypotension in approximately 1/3
        of the patients and severe hypotension is seen in 2-5% of the patients. Excellent surgical
        intervention, drier area and less blood loss, reduced facial swelling are the advantages of
        the sitting position. However, the risk of venous air embolism and increased pneumocephalus
        should not be ignored.
  
        In addition to the hemodynamic changes due to all these known positions, there is no
        follow-up of cerebral regional oxygen saturation (rSo2) monitoring depending on the position,
        which we could not detect in the literature. This monitoring can contribute to the optimal
        continuation of cerebral blood flow while deciding on the appropriate position of the
        patients. In this case, the postoperative mortality and morbidity of the patients can be
        reduced. In addition, intraoperative cerebral oxygenation monitoring is critical for
        predicting delirium in the postoperative period.
  
        Our aim in this study is to investigate the effects of the positions applied in Intracranial
        Surgery on Cerebral Oxygenation and to evaluate the superiority of the patient positions used
        to each other.
  observational model: Case-Control
  time perspective: Prospective
  measure: NIRS values
  time frame: October 1, 2022 /February 1, 2025
  arm group label: Group P
  description: Patients operated in the prone position
  arm group label: Group S
  description: Patients operated in the supine position
  arm group label: Group L
  description: Patients operated in the lateral position
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 75 Years
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Trakya University
  investigator full name: Ars Gor Dr Oguzhan Gulgen
  investigator title: Research assistant doctor