<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/NCT02220959</url>
  </required_header>
  <id_info>
    <org_study_id>14467</org_study_id>
    <nct_id>NCT02220959</nct_id>
  </id_info>
  <brief_title>Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?</brief_title>
  <official_title>Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <brief_summary>
    <textblock>
      the purpose of this study is to determine if 60 meter test done prior to surgery is a&#xD;
      predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with successful extubation</measure>
    <time_frame>postoperative 30 minutes</time_frame>
    <description>preoperative 60 meter walk test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>walk test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>morbid obese patients (BMI&gt;40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>walk test</intervention_name>
    <description>patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test</description>
    <arm_group_label>walk test</arm_group_label>
    <other_name>60 meter walk test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients between 18-60 years old&#xD;
&#xD;
          -  patients with BMI &gt; 40&#xD;
&#xD;
          -  patients undergoing Laparoscopic Sleeve Gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with Chronic obstructive pulmonary disease (COPD), Asthma,&#xD;
&#xD;
          -  patients with uncompensated heart failure&#xD;
&#xD;
          -  Uncompensated diabetes mellitus&#xD;
&#xD;
          -  Patients Who have orthopedic problems that effects the exercise test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cerrahpasa medical Faculty General surgery operation theatre</name>
      <address>
        <city>Istanbul</city>
        <zip>34500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Guniz M.Koksal</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>morbid obesity surgery</keyword>
  <keyword>walk test</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</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/NCT02220959
org study id: 14467
nct id: NCT02220959
lead sponsor: 
the purpose of this study is to determine if 60 meter test done prior to surgery is a
      predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Number of participants with successful extubation
time frame: postoperative 30 minutes
description: preoperative 60 meter walk test
arm group label: walk test
arm group type: Experimental
description: morbid obese patients (BMI>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC)
intervention type: Other
intervention name: walk test
description: patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test
arm group label: walk test
other name: 60 meter walk test
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Guniz M.Koksal
investigator title: professor
mesh term: Obesity, Morbid