<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/NCT03002857</url>
  </required_header>
  <id_info>
    <org_study_id>LMA-Urological surgery</org_study_id>
    <nct_id>NCT03002857</nct_id>
  </id_info>
  <brief_title>Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery</brief_title>
  <acronym>BCIM</acronym>
  <official_title>Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask®in Urological Surgery Regarding Their Efficacy and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adiyaman University Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turkiye Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Adiyaman University Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most used airway management strategies are different types of supraglottic airway devices&#xD;
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .&#xD;
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of&#xD;
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®&#xD;
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications&#xD;
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures&#xD;
      in urological surgery as well.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most used airway management strategies are different types of supraglottic airway devices&#xD;
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .&#xD;
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of&#xD;
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®&#xD;
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications&#xD;
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures&#xD;
      in urological surgery as well.&#xD;
&#xD;
      The main suggestion about the Baska Mask® is that it's the most appropriate airway device&#xD;
      with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this&#xD;
      causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms&#xD;
      of insertion and ventilation times, the &quot;first attempt&quot; success rates, the additional&#xD;
      maneuvering requirements and complications developed after intervention.&#xD;
&#xD;
      The secondary objective of the study was to evaluate all three SADs in terms of airway&#xD;
      pressures producing sufficient tidal volume and hemodynamical parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insertion times</measure>
    <time_frame>Perioperative</time_frame>
    <description>It was evaluated that how many secs does it take to insert properly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventilation times</measure>
    <time_frame>Perioperative</time_frame>
    <description>It was evaluated that how many secs does it take to ventilate the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>First attemp success rates</measure>
    <time_frame>Perioperative</time_frame>
    <description>In how many patients it was inserted at first attempt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The additional maneuvering</measure>
    <time_frame>Perioperative</time_frame>
    <description>ıt was evaluated how many maneuvers needed to insert the device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Airway related complications</measure>
    <time_frame>Perioperative</time_frame>
    <description>Complications like Bloodstain of the mask, Dysphagia, Tongue injury, Lips injury, Teeth injury, Palate injury, Sore throat, Hoarseness, Desaturation , Laryngospasm, Regurgitation/aspiration were evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Airway PAP and Plateau pressures</measure>
    <time_frame>Perioperative</time_frame>
    <description>Both pressures were evaluated following device insertion and then in every 10 mins.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg</measure>
    <time_frame>Perioperative</time_frame>
    <description>Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Airway Management</condition>
  <arm_group>
    <arm_group_label>Classical LMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Classical LMA insertion: LMA-C insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I-gel LMA insertion: The I-gel LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Baska Mask®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Baska Mask® insertion: The Baska Mask® insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LMA-C</intervention_name>
    <description>LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.</description>
    <arm_group_label>Classical LMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Baska Mask</intervention_name>
    <description>Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.</description>
    <arm_group_label>The Baska Mask®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-gel</intervention_name>
    <description>I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.</description>
    <arm_group_label>I-gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (ASA) 1-2-3 physical status scheduled for elective surgical procedure for&#xD;
             transurethral resection of bladder and ureteroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass&#xD;
             index (BMI) &gt; 30 kg m-2, ASA physical status 4 or over and patients who met the&#xD;
             difficult intubation criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asli Demir</last_name>
    <role>Study Director</role>
    <affiliation>Yuksek Ihtisas Research and Educational Hospital</affiliation>
  </overall_official>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>May 6, 2017</last_update_submitted>
  <last_update_submitted_qc>May 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adiyaman University Research Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Ülkü Sabuncu</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Laryngeal Mask Airway</keyword>
  <keyword>Urologic Surgical Procedure</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03002857
org study id: LMA-Urological surgery
nct id: NCT03002857
lead sponsor: 
collaborator: 
has dmc: No
The most used airway management strategies are different types of supraglottic airway devices
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures
      in urological surgery as well.
The most used airway management strategies are different types of supraglottic airway devices
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures
      in urological surgery as well.

      The main suggestion about the Baska Mask® is that it's the most appropriate airway device
      with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this
      causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms
      of insertion and ventilation times, the "first attempt" success rates, the additional
      maneuvering requirements and complications developed after intervention.

      The secondary objective of the study was to evaluate all three SADs in terms of airway
      pressures producing sufficient tidal volume and hemodynamical parameters.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Insertion times
time frame: Perioperative
description: It was evaluated that how many secs does it take to insert properly.
measure: Ventilation times
time frame: Perioperative
description: It was evaluated that how many secs does it take to ventilate the patient.
measure: First attemp success rates
time frame: Perioperative
description: In how many patients it was inserted at first attempt
measure: The additional maneuvering
time frame: Perioperative
description: ıt was evaluated how many maneuvers needed to insert the device.
measure: Airway related complications
time frame: Perioperative
description: Complications like Bloodstain of the mask, Dysphagia, Tongue injury, Lips injury, Teeth injury, Palate injury, Sore throat, Hoarseness, Desaturation , Laryngospasm, Regurgitation/aspiration were evaluated.
measure: Airway PAP and Plateau pressures
time frame: Perioperative
description: Both pressures were evaluated following device insertion and then in every 10 mins.
measure: Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg
time frame: Perioperative
description: Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins.
arm group label: Classical LMA
arm group type: Experimental
description: Classical LMA insertion: LMA-C insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.
arm group label: I-gel
arm group type: Experimental
description: I-gel LMA insertion: The I-gel LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.
arm group label: The Baska Mask®
arm group type: Experimental
description: The Baska Mask® insertion: The Baska Mask® insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.
intervention type: Device
intervention name: LMA-C
description: LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
arm group label: Classical LMA
intervention type: Device
intervention name: Baska Mask
description: Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
arm group label: The Baska Mask®
intervention type: Device
intervention name: I-gel
description: I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.
arm group label: I-gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Asli Demir
role: Study Director
affiliation: Yuksek Ihtisas Research and Educational Hospital
responsible party type: Principal Investigator
investigator affiliation: Adiyaman University Research Hospital
investigator full name: Dr. Ülkü Sabuncu
investigator title: M.D.
sharing ipd: No