xml: <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/NCT06023394</url>
    </required_header>
    <id_info>
      <org_study_id>Study00002580</org_study_id>
      <nct_id>NCT06023394</nct_id>
    </id_info>
    <brief_title>Laryngeal Mask Airway in Laparoscopic Hernia Repair</brief_title>
    <official_title>Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective randomized study will evaluate the effectiveness of laryngeal mask airway&#xD;
        (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal&#xD;
        hernia at CMH.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask&#xD;
        airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited&#xD;
        pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures&#xD;
        compared with traditional endotracheal intubation. This study aims to add to this literature&#xD;
        in providing information comparing the two techniques. The rationale for this study is to&#xD;
        show that general anesthesia with laryngeal mask airway is an effective and non-inferior&#xD;
        technique compared with general anesthesia with endotracheal intubation in pediatric patients&#xD;
        undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency&#xD;
        of care and respiratory complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 27, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 27, 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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Oxygen Saturation measured by pulse oximetry in percent saturation</measure>
      <time_frame>Patients will have oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.</time_frame>
      <description>Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>End-tidal carbon dioxide measured by capnography in mm Hg</measure>
      <time_frame>Patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.</time_frame>
      <description>Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak airway pressure will be measured in cm H2O</measure>
      <time_frame>Patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.</time_frame>
      <description>Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Documentation of laryngospasm occurrence</measure>
      <time_frame>Patients will have the occurrence of laryngospasm documented at any time point during the surgery</time_frame>
      <description>Will document if laryngospasm occurs in both groups at any time during the surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Documentation of oxygen desaturation</measure>
      <time_frame>Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.</time_frame>
      <description>Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Inguinal Hernia</condition>
    <condition>Inguinal Hernia, Indirect</condition>
    <condition>Inguinal Hernia Bilateral</condition>
    <condition>Inguinal Hernia Unilateral</condition>
    <arm_group>
      <arm_group_label>Cohort A: Receives Laryngeal Mask Airway Device</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B: Receives Endotracheal Tube Device</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Laryngeal Mask Airway</intervention_name>
      <description>Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.</description>
      <arm_group_label>Cohort A: Receives Laryngeal Mask Airway Device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endotracheal Tube Device</intervention_name>
      <description>Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.</description>
      <arm_group_label>Cohort B: Receives Endotracheal Tube Device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing laparoscopic inguinal hernia repair.&#xD;
  &#xD;
            -  Ages 12 months to 8 years of age&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status Classification ASA 1 or 2&#xD;
  &#xD;
            -  ASA 1- A normal, healthy patient&#xD;
  &#xD;
            -  ASA 2- A patient with mild systemic disease&#xD;
  &#xD;
            -  Elective with appropriate NPO status&#xD;
  &#xD;
            -  English speakers&#xD;
  &#xD;
            -  Spanish speakers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with current gastroesophageal reflux&#xD;
  &#xD;
            -  Obesity (CDC &gt;= 95th %ile)&#xD;
  &#xD;
            -  Contraindications to study protocol medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Emily Weisberg, MD</last_name>
      <phone>8164584006</phone>
      <email>eweisberg@cmh.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tolulope Oyetunji, MD</last_name>
      <phone>8162343575</phone>
      <email>taoyetunji@cmh.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Mercy Hospital</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emily Weisberg, MD</last_name>
        <phone>816-458-4006</phone>
        <email>eweisberg@cmh.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tolulope Oyetunji, MD</last_name>
        <phone>(816) 234-3575</phone>
        <email>taoyetunji@cmh.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Emily Weisberg</investigator_full_name>
      <investigator_title>Physican, M.D.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Hernia, Inguinal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023394
  org study id: Study00002580
  nct id: NCT06023394
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This prospective randomized study will evaluate the effectiveness of laryngeal mask airway
        (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal
        hernia at CMH.
  This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask
        airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited
        pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures
        compared with traditional endotracheal intubation. This study aims to add to this literature
        in providing information comparing the two techniques. The rationale for this study is to
        show that general anesthesia with laryngeal mask airway is an effective and non-inferior
        technique compared with general anesthesia with endotracheal intubation in pediatric patients
        undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency
        of care and respiratory complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Oxygen Saturation measured by pulse oximetry in percent saturation
  time frame: Patients will have oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
  description: Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
  measure: End-tidal carbon dioxide measured by capnography in mm Hg
  time frame: Patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
  description: Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.
  measure: Peak airway pressure will be measured in cm H2O
  time frame: Patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
  description: Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.
  measure: Documentation of laryngospasm occurrence
  time frame: Patients will have the occurrence of laryngospasm documented at any time point during the surgery
  description: Will document if laryngospasm occurs in both groups at any time during the surgery.
  measure: Documentation of oxygen desaturation
  time frame: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.
  description: Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
  arm group label: Cohort A: Receives Laryngeal Mask Airway Device
  arm group type: Other
  description: In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
  arm group label: Cohort B: Receives Endotracheal Tube Device
  arm group type: Other
  description: In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
  intervention type: Device
  intervention name: Laryngeal Mask Airway
  description: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
  arm group label: Cohort A: Receives Laryngeal Mask Airway Device
  intervention type: Device
  intervention name: Endotracheal Tube Device
  description: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
  arm group label: Cohort B: Receives Endotracheal Tube Device
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: 8 Years
  healthy volunteers: No
  last name: Emily Weisberg, MD
  phone: 8164584006
  email: eweisberg@cmh.edu
  last name: Tolulope Oyetunji, MD
  phone: 8162343575
  email: taoyetunji@cmh.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Emily Weisberg
  investigator title: Physican, M.D.
  mesh term: Hernia
  mesh term: Hernia, Inguinal
  sharing ipd: No