<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/NCT01724970</url>
  </required_header>
  <id_info>
    <org_study_id>2276P</org_study_id>
    <nct_id>NCT01724970</nct_id>
  </id_info>
  <brief_title>Laryngeal Masks for Bariatric Surgery</brief_title>
  <official_title>A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliera di Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obese people pose specific problems as far as the management of airway during surgery. The&#xD;
      study aims to compare efficacy and safety of two LMA devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will investigate two types of LMA devices endowed of different constructive&#xD;
      features. The two devices share common features as far as providing access to the stomach and&#xD;
      reducing morbidity of the upper airway. The two device differ in regard to ease of insertion&#xD;
      and sealing of the airway and these features are particularly important in the obese patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oropharyngeal leak pressure</measure>
    <time_frame>intraoperatively, up to 3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>total anesthetic and analgesic drug dosages</measure>
    <time_frame>intraoperatively and postoperatively, up to 24 hours from end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse oximetry saturation</measure>
    <time_frame>intraoperatively and postoperatively, up to 24 hours from end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to post-anesthetic discharge scoring system (PADSS) &gt; 8</measure>
    <time_frame>in PACU up 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EKG monitoring</measure>
    <time_frame>postoperatively up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction of the surgeon (ad hoc questionnaire)</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gastric distension</measure>
    <time_frame>intraoperatively up to 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>levels of pain and nausea (Visual Analogue Scale)</measure>
    <time_frame>postoperatively up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metilen's blue</measure>
    <time_frame>before end of surgery up to 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total dosage of analgesic and antihemetic drugs</measure>
    <time_frame>intra and postoperatively up to 24 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>insertion time</measure>
    <time_frame>up to 10 minutes</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>PLMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ProSeal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supreme LMA</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProSeal</intervention_name>
    <description>Patients will be ventilated with PLMA</description>
    <arm_group_label>PLMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Supreme LMA</intervention_name>
    <description>Patients will be ventilated with SLMA</description>
    <arm_group_label>SLMA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class I-III&#xD;
&#xD;
          -  candidates to bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled psychiatric symptomatology&#xD;
&#xD;
          -  known or presumed pregnancy&#xD;
&#xD;
          -  history of surgery on the airway or esophagus&#xD;
&#xD;
          -  gastroesophageal reflux&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Carron, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michele Carron, MD</last_name>
    <phone>+39 049 821 3090</phone>
    <email>michele.carron@unipd.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ulderico Freo, MD</last_name>
    <phone>+39 049 821 3090</phone>
    <email>ulderico.freo@unipd.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Padua</name>
      <address>
        <city>Padua</city>
        <state>PD</state>
        <zip>35121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele Carron, MD</last_name>
      <phone>+39 049 8211111</phone>
      <phone_ext>3090</phone_ext>
      <email>michele.carron@unipd.it</email>
    </contact>
    <contact_backup>
      <last_name>Ulderico Freo, MD</last_name>
      <phone>+39 049 8211111</phone>
      <phone_ext>3094</phone_ext>
      <email>ulderico.freo@unipd.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>postanesthetic recovery</keyword>
  <keyword>ventilation</keyword>
  <keyword>bariatric surgery</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/NCT01724970
org study id: 2276P
nct id: NCT01724970
lead sponsor: 
collaborator: 
has dmc: No
Obese people pose specific problems as far as the management of airway during surgery. The
      study aims to compare efficacy and safety of two LMA devices.
The study will investigate two types of LMA devices endowed of different constructive
      features. The two devices share common features as far as providing access to the stomach and
      reducing morbidity of the upper airway. The two device differ in regard to ease of insertion
      and sealing of the airway and these features are particularly important in the obese patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: oropharyngeal leak pressure
time frame: intraoperatively, up to 3 hours
measure: total anesthetic and analgesic drug dosages
time frame: intraoperatively and postoperatively, up to 24 hours from end of surgery
measure: pulse oximetry saturation
time frame: intraoperatively and postoperatively, up to 24 hours from end of surgery
measure: time to post-anesthetic discharge scoring system (PADSS) > 8
time frame: in PACU up 72 hours
measure: EKG monitoring
time frame: postoperatively up to 72 hours
measure: satisfaction of the surgeon (ad hoc questionnaire)
time frame: day 1
measure: satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
time frame: day 1
measure: gastric distension
time frame: intraoperatively up to 3 hours
measure: levels of pain and nausea (Visual Analogue Scale)
time frame: postoperatively up to 24 hours
measure: metilen's blue
time frame: before end of surgery up to 3 hours
measure: total dosage of analgesic and antihemetic drugs
time frame: intra and postoperatively up to 24 hours
measure: insertion time
time frame: up to 10 minutes
arm group label: PLMA
arm group type: Experimental
description: ProSeal
arm group label: SLMA
arm group type: Experimental
description: Supreme LMA
intervention type: Device
intervention name: ProSeal
description: Patients will be ventilated with PLMA
arm group label: PLMA
intervention type: Device
intervention name: Supreme LMA
description: Patients will be ventilated with SLMA
arm group label: SLMA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michele Carron, MD
role: Principal Investigator
affiliation: University of Padova
last name: Michele Carron, MD
phone: +39 049 821 3090
email: michele.carron@unipd.it
last name: Ulderico Freo, MD
phone: +39 049 821 3090
email: ulderico.freo@unipd.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Sponsor
mesh term: Obesity, Morbid