<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/NCT01695980</url>
  </required_header>
  <id_info>
    <org_study_id>version 4 25Jun2012</org_study_id>
    <nct_id>NCT01695980</nct_id>
  </id_info>
  <brief_title>Laryngeal Mask Airway in Pediatric Adenotonsillectomy</brief_title>
  <acronym>LMA</acronym>
  <official_title>Laryngeal Mask Airway in Pediatric Adenotonsillectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Virginia Medical School</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 study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with&#xD;
      modified retractor is used compared to use of an endotracheal tube (ETT) and non modified&#xD;
      retractor is used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The laryngeal mask airway (LMA)is a device used to secure the airway of patients during&#xD;
      general anesthesia. This device is routinely used for anesthesia in elective head and neck&#xD;
      surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be&#xD;
      studied as it pertains to operative times and cost.&#xD;
&#xD;
      The child will be randomized into either the LMA group or the ETT group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">March 29, 2022</completion_date>
  <primary_completion_date type="Actual">March 29, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.</measure>
    <time_frame>one year</time_frame>
    <description>Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine total length of procedure and recovery time with use the LMA.</measure>
    <time_frame>One year</time_frame>
    <description>Does the rate of kinking/obstruction of the tubing cause prolonged procedure time and additional issues for anesthesia and the subsequent recovery of the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Tonsillitis</condition>
  <arm_group>
    <arm_group_label>LMA with modified retractor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LMA with modified retractor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ETT with non modified retractor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ETT with non modified retractor</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ETT with non modified retractor</intervention_name>
    <description>adenotonsillectomy</description>
    <arm_group_label>ETT with non modified retractor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LMA with modified retractor</intervention_name>
    <description>LMA with modified retractor</description>
    <arm_group_label>LMA with modified retractor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis&#xD;
             between the ages of 2-16&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with BMI &gt;35&#xD;
&#xD;
          -  unwillingness to comply with study procedures&#xD;
&#xD;
          -  children with craniofacial anomalies/abnormalities which will interfere with mask&#xD;
             placement&#xD;
&#xD;
          -  children under 2 or over 16&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Baldassari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Virginia Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eastern Virginia Medical School</investigator_affiliation>
    <investigator_full_name>Cristina Baldassari M.D.</investigator_full_name>
    <investigator_title>Assistant Professor, Pediatric Otolaryngology</investigator_title>
  </responsible_party>
  <keyword>adenotonsillectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695980
org study id: version 4 25Jun2012
nct id: NCT01695980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with
      modified retractor is used compared to use of an endotracheal tube (ETT) and non modified
      retractor is used.
The laryngeal mask airway (LMA)is a device used to secure the airway of patients during
      general anesthesia. This device is routinely used for anesthesia in elective head and neck
      surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be
      studied as it pertains to operative times and cost.

      The child will be randomized into either the LMA group or the ETT group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
time frame: one year
description: Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.
measure: To determine total length of procedure and recovery time with use the LMA.
time frame: One year
description: Does the rate of kinking/obstruction of the tubing cause prolonged procedure time and additional issues for anesthesia and the subsequent recovery of the patient.
arm group label: LMA with modified retractor
arm group type: Experimental
description: LMA with modified retractor
arm group label: ETT with non modified retractor
arm group type: Active Comparator
description: ETT with non modified retractor
intervention type: Procedure
intervention name: ETT with non modified retractor
description: adenotonsillectomy
arm group label: ETT with non modified retractor
intervention type: Other
intervention name: LMA with modified retractor
description: LMA with modified retractor
arm group label: LMA with modified retractor
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Christina Baldassari, MD
role: Principal Investigator
affiliation: Eastern Virginia Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Eastern Virginia Medical School
investigator full name: Cristina Baldassari M.D.
investigator title: Assistant Professor, Pediatric Otolaryngology
mesh term: Tonsillitis
mesh term: Sleep Apnea, Obstructive