<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/NCT02252120</url>
  </required_header>
  <id_info>
    <org_study_id>Schulthess_Anä_4</org_study_id>
    <nct_id>NCT02252120</nct_id>
  </id_info>
  <brief_title>Laryngeal Mask Airway Supreme Versus Laryngeal Tube</brief_title>
  <official_title>Laryngeal Mask Airway Supreme Versus Laryngeal Tube in Non-paralysed, Anesthetized Children. A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position Using the Size 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Salzburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic&#xD;
      position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in&#xD;
      non-paralyzed anaesthetized pediatric patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well&#xD;
      established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a&#xD;
      distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the&#xD;
      ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well&#xD;
      studied laryngeal mask airway. Both devices have a drain tube to allow access to the&#xD;
      gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and&#xD;
      LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the&#xD;
      clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The&#xD;
      investigators hypothesized that design differences should lead to differences in efficacy of&#xD;
      seal and anatomic position. In this randomized, crossover study, the investigators test the&#xD;
      hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and&#xD;
      fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">September 2014</completion_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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oropharyngeal leak pressure</measure>
    <time_frame>5 Min</time_frame>
    <description>Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fiberoptic position</measure>
    <time_frame>5 Min</time_frame>
    <description>The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ease of insertion</measure>
    <time_frame>1 Min</time_frame>
    <description>We allowed one attempt before considering a failure, defining failed insertion by any of the following criteria:&#xD;
1) failed passage into the pharynx; 2) malposition (air leaks); and 3) ineffective ventilation (maximum expired tidal volume &lt;4 ml kg-1 or end-tidal CO2 &gt; 50 mm Hg (if correctly positioned). ). Insertion time was defined as the interval between picking up the prepared device and successfully placement. After placement effective ventilation was tested by observation of chest wall movement and capnometric curve trace. If insertion failed the etiology was signed on the CRF. After a first insertion attempt one single attempt with the guiding technique was allowed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Adverse Anesthesia Outcome</condition>
  <arm_group>
    <arm_group_label>Supreme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supreme LMA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal Tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal tube LTSII</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Supreme</intervention_name>
    <arm_group_label>Laryngeal Tube</arm_group_label>
    <arm_group_label>Supreme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Tube</intervention_name>
    <arm_group_label>Laryngeal Tube</arm_group_label>
    <arm_group_label>Supreme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  age 1.5 - 9 years&#xD;
&#xD;
          -  minor surgery&#xD;
&#xD;
          -  extraglottic airway device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age (&lt;18 months, &gt;9 years)&#xD;
&#xD;
          -  weight (&lt;10 kg, &gt;25 kg)&#xD;
&#xD;
          -  a known difficult airway&#xD;
&#xD;
          -  risk of aspiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Keller, MD, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schulthess Klinik, Lengghalde 2, 8008 Zürich</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 26, 2014</last_update_submitted>
  <last_update_submitted_qc>September 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schulthess Klinik</investigator_affiliation>
    <investigator_full_name>ChristianKeller</investigator_full_name>
    <investigator_title>PD Dr. med. M.Sc.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02252120
org study id: Schulthess_Anä_4
nct id: NCT02252120
lead sponsor: 
collaborator: 
has dmc: No
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic
      position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in
      non-paralyzed anaesthetized pediatric patients
The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well
      established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a
      distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the
      ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well
      studied laryngeal mask airway. Both devices have a drain tube to allow access to the
      gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and
      LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the
      clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The
      investigators hypothesized that design differences should lead to differences in efficacy of
      seal and anatomic position. In this randomized, crossover study, the investigators test the
      hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and
      fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Oropharyngeal leak pressure
time frame: 5 Min
description: Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
measure: Fiberoptic position
time frame: 5 Min
description: The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)
measure: Ease of insertion
time frame: 1 Min
description: We allowed one attempt before considering a failure, defining failed insertion by any of the following criteria:
1) failed passage into the pharynx; 2) malposition (air leaks); and 3) ineffective ventilation (maximum expired tidal volume <4 ml kg-1 or end-tidal CO2 > 50 mm Hg (if correctly positioned). ). Insertion time was defined as the interval between picking up the prepared device and successfully placement. After placement effective ventilation was tested by observation of chest wall movement and capnometric curve trace. If insertion failed the etiology was signed on the CRF. After a first insertion attempt one single attempt with the guiding technique was allowed.
arm group label: Supreme
arm group type: Active Comparator
description: Supreme LMA
arm group label: Laryngeal Tube
arm group type: Active Comparator
description: Laryngeal tube LTSII
intervention type: Device
intervention name: Supreme
arm group label: Laryngeal Tube
arm group label: Supreme
intervention type: Device
intervention name: Laryngeal Tube
arm group label: Laryngeal Tube
arm group label: Supreme
criteria: 
gender: All
minimum age: 18 Months
maximum age: 9 Years
healthy volunteers: No
last name: Christian Keller, MD, M.Sc.
role: Principal Investigator
affiliation: Schulthess Klinik, Lengghalde 2, 8008 Zürich
responsible party type: Principal Investigator
investigator affiliation: Schulthess Klinik
investigator full name: ChristianKeller
investigator title: PD Dr. med. M.Sc.