<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/NCT02977559</url>
  </required_header>
  <id_info>
    <org_study_id>BnaiZionMC-16-LG-012</org_study_id>
    <nct_id>NCT02977559</nct_id>
  </id_info>
  <brief_title>A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients</brief_title>
  <official_title>A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bnai Zion Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bnai Zion Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable&#xD;
      Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.&#xD;
&#xD;
      The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during&#xD;
      mechanical ventilation despite differences in their structural design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a&#xD;
      second generation single-use supraglottic airway devices (SADs) with gastric access, for&#xD;
      airway management in spontaneously and mechanically ventilated patients undergoing general&#xD;
      anesthesia.&#xD;
&#xD;
      The AuraGain is a second generation laryngeal mask, satisfying airway management needs by&#xD;
      integrating gastric access and ventilation capability in an anatomically curved single-use&#xD;
      device that facilitates rapid establishment of a safe airway.&#xD;
&#xD;
      The two devices have now pediatric sizes.&#xD;
&#xD;
      To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical&#xD;
      ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA&#xD;
      AG perform similarly during mechanical ventilation despite differences in their structural&#xD;
      design.&#xD;
&#xD;
      The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG&#xD;
      with respect to:&#xD;
&#xD;
        1. time to achieve an effective airway,&#xD;
&#xD;
        2. ease of insertion,&#xD;
&#xD;
        3. need for interventions to achieve an effective airway,&#xD;
&#xD;
        4. cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,&#xD;
&#xD;
        5. ventilatory variables during mechanical ventilation,&#xD;
&#xD;
        6. fiberoptic score,&#xD;
&#xD;
        7. gastric tube insertion and&#xD;
&#xD;
        8. adverse perioperative events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2017</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leak pressure measure in cm H2O</measure>
    <time_frame>60 seconds</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to insertion a device in seconds</measure>
    <time_frame>60 seconds</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Adverse Anesthesia Outcome</condition>
  <arm_group>
    <arm_group_label>Laryngeal Tube Suction Disposable</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laryngeal Tube Suction Disposable for ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal Mask Airway AuraGain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laryngeal Mask Airway AuraGain for oxygenation and ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Tube Suction Disposable</intervention_name>
    <description>Device for ventilation</description>
    <arm_group_label>Laryngeal Tube Suction Disposable</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Mask Airway AuraGain</intervention_name>
    <description>Ventilation device</description>
    <arm_group_label>Laryngeal Mask Airway AuraGain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and&#xD;
             II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with active respiratory tract infection anticipated and known difficult&#xD;
             airway, lung disease requiring high positive end expiratory pressure, and active&#xD;
             gastrointestinal reflux will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bnai Zion Medical Center</investigator_affiliation>
    <investigator_full_name>LUIS.GAITINI</investigator_full_name>
    <investigator_title>medical doctor</investigator_title>
  </responsible_party>
  <keyword>Laryngeal Tube Suction Ambu AuraGain Leak Pressure</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02977559
org study id: BnaiZionMC-16-LG-012
nct id: NCT02977559
lead sponsor: 
has dmc: Yes
The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable
      Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.

      The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during
      mechanical ventilation despite differences in their structural design.
The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a
      second generation single-use supraglottic airway devices (SADs) with gastric access, for
      airway management in spontaneously and mechanically ventilated patients undergoing general
      anesthesia.

      The AuraGain is a second generation laryngeal mask, satisfying airway management needs by
      integrating gastric access and ventilation capability in an anatomically curved single-use
      device that facilitates rapid establishment of a safe airway.

      The two devices have now pediatric sizes.

      To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical
      ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA
      AG perform similarly during mechanical ventilation despite differences in their structural
      design.

      The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG
      with respect to:

        1. time to achieve an effective airway,

        2. ease of insertion,

        3. need for interventions to achieve an effective airway,

        4. cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,

        5. ventilatory variables during mechanical ventilation,

        6. fiberoptic score,

        7. gastric tube insertion and

        8. adverse perioperative events.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Leak pressure measure in cm H2O
time frame: 60 seconds
measure: Time to insertion a device in seconds
time frame: 60 seconds
arm group label: Laryngeal Tube Suction Disposable
arm group type: Experimental
description: Laryngeal Tube Suction Disposable for ventilation
arm group label: Laryngeal Mask Airway AuraGain
arm group type: Experimental
description: Laryngeal Mask Airway AuraGain for oxygenation and ventilation
intervention type: Device
intervention name: Laryngeal Tube Suction Disposable
description: Device for ventilation
arm group label: Laryngeal Tube Suction Disposable
intervention type: Device
intervention name: Laryngeal Mask Airway AuraGain
description: Ventilation device
arm group label: Laryngeal Mask Airway AuraGain
criteria: 
gender: All
minimum age: 1 Year
maximum age: 10 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Bnai Zion Medical Center
investigator full name: LUIS.GAITINI
investigator title: medical doctor
sharing ipd: Yes