<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/NCT02202174</url>
  </required_header>
  <id_info>
    <org_study_id>2014-15832</org_study_id>
    <nct_id>NCT02202174</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Supraglottic Airway Use in Children</brief_title>
  <official_title>The Safety and Efficacy of Supraglottic Airway Use in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this study is to determine the effectiveness, risk factors, and complications&#xD;
      associated with use of supraglottic airway devices for primary airway maintenance during&#xD;
      routine anesthesia in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a&#xD;
      tertiary care Children's Hospital.&#xD;
&#xD;
      Observational data regarding the type of SGA, experience level of practitioner, placement&#xD;
      technique, number of placement attempts or placement failure, device failure, and cause of&#xD;
      any related peri-operative complications will be prospectively collected.&#xD;
&#xD;
      The data collected in this study will allow the investigators to assess the overall safety&#xD;
      and efficacy of SGA use in various medical and surgical procedures performed under general&#xD;
      anesthesia in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Supraglottic Airway Device Failure</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of Placement of Supraglottic Airway Device</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Attempts to Place Supraglottic Airway Device</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>change in device, placement method, and provider will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Maneuvers/interventions</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>the number and type of airway maneuvers performed after device placement and during maintenance will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Inadequate Ventilation</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>cause and solution for inadequate ventilation will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Complications</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Complications</measure>
    <time_frame>participants will be followed for the duration of anesthesia and 24 hours postoperatively</time_frame>
    <description>Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Supraglottic Airway Use in Children</condition>
  <arm_group>
    <arm_group_label>Supraglottic Airway Device</arm_group_label>
    <description>Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Supraglottic Airway Device</intervention_name>
    <arm_group_label>Supraglottic Airway Device</arm_group_label>
    <other_name>LMA Unique</other_name>
    <other_name>LMA ProSeal</other_name>
    <other_name>LMA Supreme</other_name>
    <other_name>LMA Flexible</other_name>
    <other_name>Ambu Aura-i</other_name>
    <other_name>Ambu Aura Once</other_name>
    <other_name>Air-Q</other_name>
    <other_name>I-Gel</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients undergoing anesthesia with use of a supraglottic airway device as&#xD;
        primary means of oxygenation and ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children undergoing anesthesia with use of a supraglottic airway device as a primary&#xD;
             means of oxygenation &amp; ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Narasimhan Jagannathan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ann &amp; Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Narasimhan Jagannathan, MD</last_name>
    <phone>3122275170</phone>
    <email>njagannathan@luriechildrens.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Narasimhan Jagannathan, MD</last_name>
      <email>simjag2000@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Narasimhan Jagannathan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.</citation>
    <PMID>24322570</PMID>
  </reference>
  <reference>
    <citation>Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.</citation>
    <PMID>24561643</PMID>
  </reference>
  <reference>
    <citation>Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.</citation>
    <PMID>8984875</PMID>
  </reference>
  <reference>
    <citation>Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.</citation>
    <PMID>12519134</PMID>
  </reference>
  <reference>
    <citation>Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.</citation>
    <PMID>23063385</PMID>
  </reference>
  <reference>
    <citation>Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.</citation>
    <PMID>24126262</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</investigator_affiliation>
    <investigator_full_name>Narasimhan Jagannathan</investigator_full_name>
    <investigator_title>Primary Investigator; MD</investigator_title>
  </responsible_party>
  <keyword>supraglottic airway</keyword>
  <keyword>children</keyword>
  <keyword>safety</keyword>
  <keyword>efficacy</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/NCT02202174
org study id: 2014-15832
nct id: NCT02202174
lead sponsor: 
has dmc: No
This purpose of this study is to determine the effectiveness, risk factors, and complications
      associated with use of supraglottic airway devices for primary airway maintenance during
      routine anesthesia in children.
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a
      tertiary care Children's Hospital.

      Observational data regarding the type of SGA, experience level of practitioner, placement
      technique, number of placement attempts or placement failure, device failure, and cause of
      any related peri-operative complications will be prospectively collected.

      The data collected in this study will allow the investigators to assess the overall safety
      and efficacy of SGA use in various medical and surgical procedures performed under general
      anesthesia in children.
observational model: Cohort
time perspective: Prospective
measure: Supraglottic Airway Device Failure
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
measure: Ease of Placement of Supraglottic Airway Device
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
measure: Multiple Attempts to Place Supraglottic Airway Device
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: change in device, placement method, and provider will be recorded
measure: Airway Maneuvers/interventions
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
measure: Occurrence of Inadequate Ventilation
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: cause and solution for inadequate ventilation will be recorded
measure: Intraoperative Complications
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded
measure: Postoperative Complications
time frame: participants will be followed for the duration of anesthesia and 24 hours postoperatively
description: Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
arm group label: Supraglottic Airway Device
description: Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines
intervention type: Device
intervention name: Supraglottic Airway Device
arm group label: Supraglottic Airway Device
other name: LMA Unique
other name: LMA ProSeal
other name: LMA Supreme
other name: LMA Flexible
other name: Ambu Aura-i
other name: Ambu Aura Once
other name: Air-Q
other name: I-Gel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Narasimhan Jagannathan, MD
role: Principal Investigator
affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
last name: Narasimhan Jagannathan, MD
phone: 3122275170
email: njagannathan@luriechildrens.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.
PMID: 24322570
citation: Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.
PMID: 24561643
citation: Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
PMID: 8984875
citation: Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.
PMID: 12519134
citation: Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.
PMID: 23063385
citation: Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
PMID: 24126262
responsible party type: Principal Investigator
investigator affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
investigator full name: Narasimhan Jagannathan
investigator title: Primary Investigator; MD