<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/NCT03838705</url>
  </required_header>
  <id_info>
    <org_study_id>SS1</org_study_id>
    <nct_id>NCT03838705</nct_id>
  </id_info>
  <brief_title>The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool</brief_title>
  <official_title>The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sibel Ocak Serin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aysun Isiklar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Umraniye 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>
      In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable&#xD;
      Screening questionnaires in postoperative period in patients who underwent bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SpO2</measure>
    <time_frame>48 hours</time_frame>
    <description>Peripheral Oxygen Saturation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>STOP-BANG</measure>
    <time_frame>preoperative 24 hours</time_frame>
    <description>The value of STOP-BANG questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4-V Tool</measure>
    <time_frame>preoperative 24 hours</time_frame>
    <description>The value of 4-V Tool</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Hypoxia</condition>
  <condition>Bariatric Surgery</condition>
  <arm_group>
    <arm_group_label>bariatric surgery patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients aged 18-65 years with ASA status II-III, BMI&gt;40 who were undergoing bariatric surgery operation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hypoxia</intervention_name>
    <description>It was accepted that hypoxia developed in patients with SpO2&lt; 92 or falling over 20% compared to preoperative values.</description>
    <arm_group_label>bariatric surgery patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>normooxy</intervention_name>
    <description>It was accepted that patients with SpO2 between 100-92 mmHg</description>
    <arm_group_label>bariatric surgery patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;40&#xD;
&#xD;
          -  bariatric surgery patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  patients who are unable to complete the questionnaire&#xD;
&#xD;
          -  patients who needs laparotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sibel O Serin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Umraniye Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Umraniye Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gulsah Karaoren</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>stop-bang, bariatric surgery, obesity, hypoxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT03838705
org study id: SS1
nct id: NCT03838705
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable
      Screening questionnaires in postoperative period in patients who underwent bariatric surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: SpO2
time frame: 48 hours
description: Peripheral Oxygen Saturation
measure: STOP-BANG
time frame: preoperative 24 hours
description: The value of STOP-BANG questionnaire
measure: 4-V Tool
time frame: preoperative 24 hours
description: The value of 4-V Tool
arm group label: bariatric surgery patients
arm group type: Other
description: patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation
intervention type: Procedure
intervention name: hypoxia
description: It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.
arm group label: bariatric surgery patients
intervention type: Procedure
intervention name: normooxy
description: It was accepted that patients with SpO2 between 100-92 mmHg
arm group label: bariatric surgery patients
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sibel O Serin, MD
role: Study Director
affiliation: Umraniye Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Gulsah Karaoren
investigator title: Associate professor
mesh term: Hypoxia
sharing ipd: No