<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/NCT01704118</url>
  </required_header>
  <id_info>
    <org_study_id>Inonu University</org_study_id>
    <nct_id>NCT01704118</nct_id>
  </id_info>
  <brief_title>Comparison of Size 1 I-gel and ProSeal Laryngeal Mask</brief_title>
  <official_title>Is Size 1 I-gel More Effective Than Size 1 ProSeal Laryngeal Mask for Anesthetized Infants and Neonates?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective of this prospective, randomized and controlled study is to compare the performances&#xD;
      of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with&#xD;
      prospective studies. In this study, primer endpoint was value of airway leak pressure and&#xD;
      secondary insertion time, insertion success and conditions, initial airway quality,&#xD;
      hemodynamic parameters, fiberoptic view and complications will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Routine monitorization will be performed. Lidocaine 1 mg.kg-1, remifentanil 1 mcg.kg-1 (slow&#xD;
      bolus in approximately 1 minute) and 3 mg.kg-1 propofol will be administered in anaesthesia&#xD;
      induction.&#xD;
&#xD;
      In Group P, PLMA with fully deflated cuff and applied water-based lubricant, will be inserted&#xD;
      using a metal introducer. After insertion, cuff will be inflated with a recommended volume of&#xD;
      air and then cuff pressure will be adjusted to 60 cm H2O with manometer.&#xD;
&#xD;
      In Group I, I-gel with its cuff lubricated will be orally inserted along the hard palate&#xD;
      until resistance will be felt, as recommended by the manufacturer.&#xD;
&#xD;
      The time between picking up the prepared PLMA (with introducer and deflated cuff) or I-gel&#xD;
      and the appearance of the first stable capnographic trace will be recorded as the insertion&#xD;
      time. The conditions for insertion will be ere scored according to mouth (1: full, 2:&#xD;
      partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2:&#xD;
      slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil,&#xD;
      2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).&#xD;
&#xD;
      Fresh gas flow will be adjusted to 3 L.min-1, and after closing the expiratory valve the&#xD;
      airway pressure at which an audible leak in the mouth occurred will recorded as the 'Pleak'.&#xD;
      When Pleak reach 35 cm H2O, expiratory valve will be opened.&#xD;
&#xD;
      Anatomical position of airway device will viewed by inserting fiberoptic bronchoscope through&#xD;
      the ventilation tube.&#xD;
&#xD;
      Complications encountered during and at the end of the operation such as desaturation (sPO2&#xD;
      less than 90%), gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain&#xD;
      on the airway device during removal will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Airway leak pressure</measure>
    <time_frame>1 year (After anesthesia induction)</time_frame>
    <description>Fresh gas flow will adjust to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will be recorded as the 'Pleak'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion time and conditions</measure>
    <time_frame>1year (During maintainance of anesthesia)</time_frame>
    <description>The time between picking up the device and the appearance of the first stable capnographic trace will be recorded as the insertion time. The conditions for insertion were scored according to mouth (1: full, 2: partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2: slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil, 2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initial airway quality</measure>
    <time_frame>During maintainance of anesthesia</time_frame>
    <description>Initial airway quality will be evaluated with manual ventilation by adjusting APL valve to 20 cm H2O. Evaluation will be performed with a scale as excellent (no leaks heard), good/acceptable (a slight, clinically insignificant leak, sufficient ventilation) and poor/unacceptable (significant leak and insufficient ventilation which requires reposition or relocation of device) by listening to lungs, epigastrium and perilaryngeal field and observing the expansion of thorax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of fiberoptic view</measure>
    <time_frame>1 year (During maintainance of anesthesia)</time_frame>
    <description>The breathing system will be disconnected and fiberoptic bronchoscope will be inserted through the ventilation tube to evaluate glottic view. Fiberoptic images will be recorded by using a digital camera. The images will be graded according to the score of 1 to 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1year(During maintainance of anesthesia)</time_frame>
    <description>Complications encountered during and at the end of the operation such as desaturation, gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain on the airway device during removal will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Laryngeal Masks</condition>
  <arm_group>
    <arm_group_label>I-gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a disposable supraglottic airway device with a non-inflatable cuff in which part of that is fixed on glottis is made of thermoplastic elastomer, unlike other laryngeal masks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ProSeal Laryngeal mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ProSeal laryngeal mask (PLMA) (LMA North America, Inc., San Diego, USA) is a modified type of LMA (larger and deeper bowl and enlarged and softer cuff) with gastric drainage tube.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-gel</intervention_name>
    <description>Supraglottic airway device</description>
    <arm_group_label>I-gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProSeal Laryngeal mask</intervention_name>
    <description>Supraglottic airway device</description>
    <arm_group_label>ProSeal Laryngeal mask</arm_group_label>
    <other_name>PLMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infants and neonates, that to be used supraglottic airway and that plan to be taken&#xD;
        elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infants having a history of pulmonary disease and expect to have aspiration&#xD;
        (gastroesophageal reflux, gastrointestinal stenosis or stricture) and a difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gulay Erdogan Kayhan</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor, MD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inonu University Turgut Ozal Medical Center</name>
      <address>
        <city>Malatya</city>
        <zip>44315</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Gulay ERDOGAN KAYHAN</investigator_full_name>
    <investigator_title>Assistant Prof,MD</investigator_title>
  </responsible_party>
  <keyword>I-gel</keyword>
  <keyword>ProSeal laryngeal mask</keyword>
  <keyword>small infants</keyword>
  <keyword>neonates</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/NCT01704118
org study id: Inonu University
nct id: NCT01704118
lead sponsor: 
has dmc: Yes
Objective of this prospective, randomized and controlled study is to compare the performances
      of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with
      prospective studies. In this study, primer endpoint was value of airway leak pressure and
      secondary insertion time, insertion success and conditions, initial airway quality,
      hemodynamic parameters, fiberoptic view and complications will be assessed.
Routine monitorization will be performed. Lidocaine 1 mg.kg-1, remifentanil 1 mcg.kg-1 (slow
      bolus in approximately 1 minute) and 3 mg.kg-1 propofol will be administered in anaesthesia
      induction.

      In Group P, PLMA with fully deflated cuff and applied water-based lubricant, will be inserted
      using a metal introducer. After insertion, cuff will be inflated with a recommended volume of
      air and then cuff pressure will be adjusted to 60 cm H2O with manometer.

      In Group I, I-gel with its cuff lubricated will be orally inserted along the hard palate
      until resistance will be felt, as recommended by the manufacturer.

      The time between picking up the prepared PLMA (with introducer and deflated cuff) or I-gel
      and the appearance of the first stable capnographic trace will be recorded as the insertion
      time. The conditions for insertion will be ere scored according to mouth (1: full, 2:
      partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2:
      slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil,
      2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).

      Fresh gas flow will be adjusted to 3 L.min-1, and after closing the expiratory valve the
      airway pressure at which an audible leak in the mouth occurred will recorded as the 'Pleak'.
      When Pleak reach 35 cm H2O, expiratory valve will be opened.

      Anatomical position of airway device will viewed by inserting fiberoptic bronchoscope through
      the ventilation tube.

      Complications encountered during and at the end of the operation such as desaturation (sPO2
      less than 90%), gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain
      on the airway device during removal will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Airway leak pressure
time frame: 1 year (After anesthesia induction)
description: Fresh gas flow will adjust to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will be recorded as the 'Pleak'.
measure: Insertion time and conditions
time frame: 1year (During maintainance of anesthesia)
description: The time between picking up the device and the appearance of the first stable capnographic trace will be recorded as the insertion time. The conditions for insertion were scored according to mouth (1: full, 2: partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2: slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil, 2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).
measure: Initial airway quality
time frame: During maintainance of anesthesia
description: Initial airway quality will be evaluated with manual ventilation by adjusting APL valve to 20 cm H2O. Evaluation will be performed with a scale as excellent (no leaks heard), good/acceptable (a slight, clinically insignificant leak, sufficient ventilation) and poor/unacceptable (significant leak and insufficient ventilation which requires reposition or relocation of device) by listening to lungs, epigastrium and perilaryngeal field and observing the expansion of thorax.
measure: Evaluation of fiberoptic view
time frame: 1 year (During maintainance of anesthesia)
description: The breathing system will be disconnected and fiberoptic bronchoscope will be inserted through the ventilation tube to evaluate glottic view. Fiberoptic images will be recorded by using a digital camera. The images will be graded according to the score of 1 to 5.
measure: Complications
time frame: 1year(During maintainance of anesthesia)
description: Complications encountered during and at the end of the operation such as desaturation, gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain on the airway device during removal will be recorded.
arm group label: I-gel
arm group type: Experimental
description: I-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a disposable supraglottic airway device with a non-inflatable cuff in which part of that is fixed on glottis is made of thermoplastic elastomer, unlike other laryngeal masks
arm group label: ProSeal Laryngeal mask
arm group type: Active Comparator
description: ProSeal laryngeal mask (PLMA) (LMA North America, Inc., San Diego, USA) is a modified type of LMA (larger and deeper bowl and enlarged and softer cuff) with gastric drainage tube.
intervention type: Device
intervention name: I-gel
description: Supraglottic airway device
arm group label: I-gel
intervention type: Device
intervention name: ProSeal Laryngeal mask
description: Supraglottic airway device
arm group label: ProSeal Laryngeal mask
other name: PLMA
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Gulay Erdogan Kayhan
role: Study Director
affiliation: Assistant Professor, MD
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Gulay ERDOGAN KAYHAN
investigator title: Assistant Prof,MD