<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/NCT02980770</url>
  </required_header>
  <id_info>
    <org_study_id>70737436-050.06.04</org_study_id>
    <nct_id>NCT02980770</nct_id>
  </id_info>
  <brief_title>Postoperative Complications in Patients With Obesity Hypoventilation Syndrome</brief_title>
  <acronym>OHBE</acronym>
  <official_title>Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Elazig Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mustafa Kemal University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haydarpasa Numune Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Konya Meram State Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Adana Numune Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tepecik Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Trakya University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Turkiye Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ufuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kasımpasa Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nevsehir Public Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hitit University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bulent Ecevit University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common&#xD;
      conditions in obesity, which may influence the prognosis in patients undergoing surgery.&#xD;
      There is a need for simple screening tools to identify such patients at high risk. The&#xD;
      current multicenter observational study aims to investigate occurrence of OSA and OHS in&#xD;
      obese individuals undergoing elective abdominal surgery and further address its impact on&#xD;
      perioperative and postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common&#xD;
      conditions in obesity, which may influence the prognosis in patients undergoing surgery.&#xD;
      There is a need for simple screening tools to identify such patients at high risk. The&#xD;
      current multicenter observational study aims to investigate occurrence of OSA and OHS in&#xD;
      obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG&#xD;
      questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases.&#xD;
      Perioperative and 72-h postoperative complications will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>
  <primary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">999</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Obesity Hypoventilation Syndrome</condition>
  <condition>Hypercapnia</condition>
  <condition>Post-Op Complication</condition>
  <condition>Acid-Base Imbalance</condition>
  <arm_group>
    <arm_group_label>Obstructive Sleep Apnea (OSA)</arm_group_label>
    <description>Patients with OSA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obesity-Hypoventilation Syndrome (OHS)</arm_group_label>
    <description>Patients with OHS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Blood Gases</arm_group_label>
    <description>Normal Blood Gases</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biochemistry, blood gases&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive obese patients undergoing elective abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective abdominal surgery&#xD;
&#xD;
          -  Body-Mass-Index &gt;=30 kg/m2&#xD;
&#xD;
          -  Ability to read and speak&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of diuretics&#xD;
&#xD;
          -  Use of theophylline&#xD;
&#xD;
          -  Use of respiratory depressing drugs&#xD;
&#xD;
          -  Severe lung disease (FEV1/FVC&lt;%50)&#xD;
&#xD;
          -  Severe hearth failure (EF&lt;%35)&#xD;
&#xD;
          -  Central nervous system or muscle disease&#xD;
&#xD;
          -  Untreated hypothyroidism&#xD;
&#xD;
          -  Renal failure (GFR&lt;50)&#xD;
&#xD;
          -  Total parenteral nutrition more than 72 hours&#xD;
&#xD;
          -  Hypokalemia&#xD;
&#xD;
          -  Hyponatremia&#xD;
&#xD;
          -  Hypomagnesemia&#xD;
&#xD;
          -  Hypoalbuminemia&#xD;
&#xD;
          -  Known sleep apnea or obesity hypoventilation syndrome&#xD;
&#xD;
          -  Blood transfusion from blood bank within 72 hours prior to surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail Cinel, Prof Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Marmara University Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ismail Cinel, Prof Dr</last_name>
    <phone>+905324129596</phone>
    <email>cinelismail@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuksel Peker, Prof Dr</last_name>
    <phone>+905443484866</phone>
    <email>yukselpeker26@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Marmara University Pendik Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ismail Cinel, Prof Dr</last_name>
      <phone>+905324129596</phone>
      <email>cinelismail@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Fethi Gül, MD</last_name>
      <phone>+905056000385</phone>
      <email>gulfethi@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Obesity Hypoventilation Syndrome</keyword>
  <keyword>Hypercapnia</keyword>
  <keyword>Post-Op Complication</keyword>
  <keyword>Acid-Base Imbalance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Hypoventilation</mesh_term>
    <mesh_term>Obesity Hypoventilation Syndrome</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Acid-Base Imbalance</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Hypercapnia</mesh_term>
  </condition_browse>
  <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/NCT02980770
org study id: 70737436-050.06.04
nct id: NCT02980770
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has dmc: No
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common
      conditions in obesity, which may influence the prognosis in patients undergoing surgery.
      There is a need for simple screening tools to identify such patients at high risk. The
      current multicenter observational study aims to investigate occurrence of OSA and OHS in
      obese individuals undergoing elective abdominal surgery and further address its impact on
      perioperative and postoperative complications.
Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common
      conditions in obesity, which may influence the prognosis in patients undergoing surgery.
      There is a need for simple screening tools to identify such patients at high risk. The
      current multicenter observational study aims to investigate occurrence of OSA and OHS in
      obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG
      questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases.
      Perioperative and 72-h postoperative complications will be documented.
observational model: Cohort
time perspective: Prospective
measure: Postoperative complications
time frame: 72 hours
arm group label: Obstructive Sleep Apnea (OSA)
description: Patients with OSA
arm group label: Obesity-Hypoventilation Syndrome (OHS)
description: Patients with OHS
arm group label: Normal Blood Gases
description: Normal Blood Gases
Biochemistry, blood gases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ismail Cinel, Prof Dr
role: Study Chair
affiliation: Marmara University Medical School
last name: Ismail Cinel, Prof Dr
phone: +905324129596
email: cinelismail@yahoo.com
last name: Yuksel Peker, Prof Dr
phone: +905443484866
email: yukselpeker26@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypoventilation
mesh term: Obesity Hypoventilation Syndrome
mesh term: Obesity
mesh term: Acid-Base Imbalance
mesh term: Syndrome
mesh term: Postoperative Complications
mesh term: Hypercapnia
sharing ipd: No