<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/NCT03760679</url>
  </required_header>
  <id_info>
    <org_study_id>341-SBKAEK</org_study_id>
    <nct_id>NCT03760679</nct_id>
  </id_info>
  <brief_title>Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients</brief_title>
  <official_title>Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to evaluate ease and duration of placing Laryngeal Mask&#xD;
      Supreme (LM) and applying I-gel in geriatric patients without teeth. The secondary aim is to&#xD;
      compare their effects on ventilation parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective&#xD;
      laparoscopic gynecological surgery.&#xD;
&#xD;
      The patients are randomly assigned to 2 groups:&#xD;
&#xD;
        -  Group 1: i-gel&#xD;
&#xD;
        -  Group 2: laryngeal mask airway - Supreme&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      The investigation protocol contains the following sections:&#xD;
&#xD;
        1. Induction of anaesthesia: Preoxygenation will be provided at 6 Liter/min oxygen for&#xD;
           three minutes by using a facial mask. After anesthesia induction with fentanyl 1-2 μg/kg&#xD;
           and propofol 1-2 mg/kg (12), mask ventilation will be applied with 100% oxygen.&#xD;
&#xD;
        2. Bispectral index values will be held between 40-60.Bispectral index values will be&#xD;
           within this interval by increasing or decreasing propofol infusion by 1 mg/kg after&#xD;
           additional bolus dose of propofol (1 mg/kg).&#xD;
&#xD;
        3. Insertion of the airway device. The size of the airway device used is based on the&#xD;
           manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once&#xD;
           inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size&#xD;
           of airway device, time an number of attempts.&#xD;
&#xD;
        4. Maintenance of anesthesia will be achieved with sevoflurane 1,5-2,5% in a mixture of 50%&#xD;
           O2/ 50% nitrogen protoxide. Sevoflurane concentrations will be adjusted to keep&#xD;
           bispectral index values at 40-60.&#xD;
&#xD;
        5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and&#xD;
           two minutes after the airway tool is placed, every 15 minutes until the operation ends&#xD;
           and before the airway tool is removed.&#xD;
&#xD;
        6. Ventilatory mechanics and parameters and hemodynamic parameters are measured at&#xD;
           baseline, and two minutes after the airway tool is placed, every 15 minutes until the&#xD;
           operation ends and before the airway tool is removed.&#xD;
&#xD;
        7. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor&#xD;
&#xD;
        8. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace&#xD;
           amounts of blood; 3: clear amounts of blood). Complications: sore throat (visual&#xD;
           analogue scale :10-point scale), dysphonia (yes/no), dysphagia (yes/no).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Airway Seal Pressure Values</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>insertion time</measure>
    <time_frame>intraoperative</time_frame>
    <description>placement of airway device (second)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sore throat</measure>
    <time_frame>postoperative 1th hour and 24th hour</time_frame>
    <description>postoperative pharyngolaryngeal morbidity- (Visual Analog Pain Scale is a unidimensional measure of pain intensity ), (&quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100 [100-mm scale])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dysphagia</measure>
    <time_frame>postoperative 1th hour and 24th hour</time_frame>
    <description>postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dysphonia</measure>
    <time_frame>postoperative 1th hour and 24th hour</time_frame>
    <description>postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Airway Morbidity</condition>
  <arm_group>
    <arm_group_label>Laryngeal mask Supreme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Laryngeal mask Supreme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>i-gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: i-gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal mask Supreme evaluation</intervention_name>
    <description>Device: Laryngeal mask Supreme evaluation</description>
    <arm_group_label>Laryngeal mask Supreme</arm_group_label>
    <other_name>Device: Laryngeal mask Supreme evaluation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-gel evaluation</intervention_name>
    <description>Device: i-gel evaluation</description>
    <arm_group_label>i-gel</arm_group_label>
    <other_name>Device: i-gel evaluation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists Classification I-III patients&#xD;
&#xD;
          -  patients aged 65 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having teeth or fixed prosthesis&#xD;
&#xD;
          -  having a pathology of the neck or the upper respiratory tract&#xD;
&#xD;
          -  having a risk of regurgitation of gastric content/ aspiration (prior upper&#xD;
             gastrointestinal system surgery, hiatus hernia, gastrointestinal reflux, history of&#xD;
             peptic ulcer and full stomach)&#xD;
&#xD;
          -  history or possibility of difficult airway (history of impossible intubation,&#xD;
             mallampati score of 3-4, sternomental distance of shorter than 12 cm, thyromental&#xD;
             distance of shorter than 6cm, head extension of lower than 90 degrees and mouth&#xD;
             opening of lower than 1.5 cm)&#xD;
&#xD;
          -  lower pulmonary compliance or higher airway resistance (morbid obesity -BMI&gt;35kg/m2-&#xD;
             and pulmonary disease) Each patient will be examined preoperatively and American&#xD;
             Society of Anesthesiologists Classification scores and mallampati scores will be&#xD;
             recorded. Standard monitoring (ECG, pulse oximetry and noninvasive blood pressure&#xD;
             measurement) and bispectral index monitoring will be performed in each patient before&#xD;
             induction of anesthesia in the surgical room.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sibel Büyükçoban</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Şule Özbilgin</last_name>
    <phone>05055252901</phone>
    <email>ozbilginsule@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sibel Büyükçoban</last_name>
    <email>sibelbuyukcoban@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Şule Özbilgin</name>
      <address>
        <city>İzmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Şule Özbilgin</last_name>
      <phone>5055252901</phone>
      <email>ozbilginsule@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sibel Büyükçoban, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Sule Ozbilgin</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>laryngeal mask</keyword>
  <keyword>geriatric</keyword>
  <keyword>patient</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03760679
org study id: 341-SBKAEK
nct id: NCT03760679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to evaluate ease and duration of placing Laryngeal Mask
      Supreme (LM) and applying I-gel in geriatric patients without teeth. The secondary aim is to
      compare their effects on ventilation parameters.
Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective
      laparoscopic gynecological surgery.

      The patients are randomly assigned to 2 groups:

        -  Group 1: i-gel

        -  Group 2: laryngeal mask airway - Supreme

      Procedure:

      The investigation protocol contains the following sections:

        1. Induction of anaesthesia: Preoxygenation will be provided at 6 Liter/min oxygen for
           three minutes by using a facial mask. After anesthesia induction with fentanyl 1-2 μg/kg
           and propofol 1-2 mg/kg (12), mask ventilation will be applied with 100% oxygen.

        2. Bispectral index values will be held between 40-60.Bispectral index values will be
           within this interval by increasing or decreasing propofol infusion by 1 mg/kg after
           additional bolus dose of propofol (1 mg/kg).

        3. Insertion of the airway device. The size of the airway device used is based on the
           manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once
           inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size
           of airway device, time an number of attempts.

        4. Maintenance of anesthesia will be achieved with sevoflurane 1,5-2,5% in a mixture of 50%
           O2/ 50% nitrogen protoxide. Sevoflurane concentrations will be adjusted to keep
           bispectral index values at 40-60.

        5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and
           two minutes after the airway tool is placed, every 15 minutes until the operation ends
           and before the airway tool is removed.

        6. Ventilatory mechanics and parameters and hemodynamic parameters are measured at
           baseline, and two minutes after the airway tool is placed, every 15 minutes until the
           operation ends and before the airway tool is removed.

        7. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor

        8. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace
           amounts of blood; 3: clear amounts of blood). Complications: sore throat (visual
           analogue scale :10-point scale), dysphonia (yes/no), dysphagia (yes/no).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Airway Seal Pressure Values
time frame: intraoperative
measure: insertion time
time frame: intraoperative
description: placement of airway device (second)
measure: sore throat
time frame: postoperative 1th hour and 24th hour
description: postoperative pharyngolaryngeal morbidity- (Visual Analog Pain Scale is a unidimensional measure of pain intensity ), ("no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
measure: dysphagia
time frame: postoperative 1th hour and 24th hour
description: postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)
measure: dysphonia
time frame: postoperative 1th hour and 24th hour
description: postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)
arm group label: Laryngeal mask Supreme
arm group type: Active Comparator
description: Device: Laryngeal mask Supreme
arm group label: i-gel
arm group type: Experimental
description: Device: i-gel
intervention type: Device
intervention name: Laryngeal mask Supreme evaluation
description: Device: Laryngeal mask Supreme evaluation
arm group label: Laryngeal mask Supreme
other name: Device: Laryngeal mask Supreme evaluation
intervention type: Device
intervention name: i-gel evaluation
description: Device: i-gel evaluation
arm group label: i-gel
other name: Device: i-gel evaluation
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Sibel Büyükçoban
role: Principal Investigator
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
last name: Şule Özbilgin
phone: 05055252901
email: ozbilginsule@gmail.com
last name: Sibel Büyükçoban
email: sibelbuyukcoban@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Sule Ozbilgin
investigator title: Investigator
mesh term: Chlorhexidine
sharing ipd: Undecided