<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/NCT01703897</url>
  </required_header>
  <id_info>
    <org_study_id>Linde-Imped</org_study_id>
    <nct_id>NCT01703897</nct_id>
  </id_info>
  <brief_title>Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia</brief_title>
  <official_title>Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Örebro University, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in&#xD;
      obese patients before and during anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is an increasing heath problem in western countries and is associated with increased&#xD;
      risks during anesthesia.&#xD;
&#xD;
      Using high-resolution solid-state manometry the investigators aim to study esophageal&#xD;
      pressures and measure the incidence of regurgitation of gastric contents during anesthesia&#xD;
      induction in obese patients. The investigators aim to include 16 obese patients, with BMI &gt;&#xD;
      35, undergoing laparoscopic gastric by-pass.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>October 2012</start_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>Esophageal pressures after laparoscopic gastric by pass</measure>
    <time_frame>2 years after surgery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manometry and Impedance analysis</intervention_name>
    <arm_group_label>Obese patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  aged 18-60 years&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
          -  ASA classification I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of drugs that interfere with esophageal motility&#xD;
&#xD;
          -  Gastro-esophageal reflux disease&#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>Department of Anesthesiology and Intensive care, University Hospital of Örebro</name>
      <address>
        <city>Örebro</city>
        <zip>70162</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro University, Sweden</investigator_affiliation>
    <investigator_full_name>Alex de Leon</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>gastric by-pass surgery</keyword>
  <!-- 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/NCT01703897
org study id: Linde-Imped
nct id: NCT01703897
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in
      obese patients before and during anesthesia.
Obesity is an increasing heath problem in western countries and is associated with increased
      risks during anesthesia.

      Using high-resolution solid-state manometry the investigators aim to study esophageal
      pressures and measure the incidence of regurgitation of gastric contents during anesthesia
      induction in obese patients. The investigators aim to include 16 obese patients, with BMI >
      35, undergoing laparoscopic gastric by-pass.
observational model: Cohort
time perspective: Prospective
measure: Esophageal pressures after laparoscopic gastric by pass
time frame: 2 years after surgery
arm group label: Obese patients
intervention type: Device
intervention name: Manometry and Impedance analysis
arm group label: Obese patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Örebro University, Sweden
investigator full name: Alex de Leon
investigator title: MD, PhD