<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/NCT01707511</url>
  </required_header>
  <id_info>
    <org_study_id>Diskapianesthesia-01</org_study_id>
    <nct_id>NCT01707511</nct_id>
  </id_info>
  <brief_title>The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery</brief_title>
  <official_title>Cohort Study on Patients Underwent Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value&#xD;
      of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between&#xD;
      Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient&#xD;
      and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure&#xD;
      values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also&#xD;
      investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient records from patients underwent colorectal surgery between 2010-2011 will be studied.&#xD;
      It was planned to include patients undergoing laparoscopic colorectal surgery with a&#xD;
      predetermined anaesthesia protocol.&#xD;
&#xD;
      Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia.&#xD;
      Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age,&#xD;
      gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position&#xD;
      and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and&#xD;
      EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between&#xD;
      PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data&#xD;
      regarding blood gas analyzes. Preoperative period: to, 10th minute after the first&#xD;
      insuflation and trendelendburg position: t₁,the first hour after the first insuflation and&#xD;
      trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th&#xD;
      minute after the second insuflation and trendelendburg position: t₄, and 10th minute after&#xD;
      the second desuflation and supine position:t₅. Primary outcome measure is the difference&#xD;
      between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Colorectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled whom planned for elective laparoscopic colorectal resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III patients underwent laparoscopic colorectal resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  convertion to the open surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustafa Ozmen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diskapi Yildirim Beyazit Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diskapi Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <state>Altindag</state>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dilek Yazicioglu, specialist</last_name>
      <phone>+903125962553</phone>
    </contact>
    <investigator>
      <last_name>Mustafa Ozmen, assistant</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mustafa Ozmen</investigator_full_name>
    <investigator_title>principal İnvestigator</investigator_title>
  </responsible_party>
  <keyword>Arterial carbondioxide pressure</keyword>
  <keyword>Colon surgery</keyword>
  <keyword>End-tidal carbondioxide</keyword>
  <keyword>Laparoscopic Trendelenburg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01707511
org study id: Diskapianesthesia-01
nct id: NCT01707511
lead sponsor: 
has dmc: No
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value
      of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between
      Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient
      and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure
      values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also
      investigated.
Patient records from patients underwent colorectal surgery between 2010-2011 will be studied.
      It was planned to include patients undergoing laparoscopic colorectal surgery with a
      predetermined anaesthesia protocol.

      Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia.
      Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age,
      gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position
      and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and
      EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between
      PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data
      regarding blood gas analyzes. Preoperative period: to, 10th minute after the first
      insuflation and trendelendburg position: t₁,the first hour after the first insuflation and
      trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th
      minute after the second insuflation and trendelendburg position: t₄, and 10th minute after
      the second desuflation and supine position:t₅. Primary outcome measure is the difference
      between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mustafa Ozmen, MD
role: Principal Investigator
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: Mustafa Ozmen
investigator title: principal İnvestigator
mesh term: Colorectal Neoplasms