<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/NCT02189590</url>
  </required_header>
  <id_info>
    <org_study_id>I-gel versus air-Q</org_study_id>
    <nct_id>NCT02189590</nct_id>
  </id_info>
  <brief_title>Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children</brief_title>
  <official_title>A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation 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>
      The purpose of this study is to determine if there is a difference in time for successful&#xD;
      fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for&#xD;
      fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be&#xD;
      performed by residents in training. The primary outcome is of time for successful tracheal&#xD;
      intubation. The investigators hypothesize that residents will intubate the trachea faster&#xD;
      when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic&#xD;
      airway device, fiberoptic grade of laryngeal view, time for device removal after intubation,&#xD;
      and peri-operative complications will also be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Successful Tracheal Intubation</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 to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of Placement of Supraglottic Airway</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 device ranging from 1 (easy) to 4 (difficult).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Attempts to Place the Supraglottic 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>Number of attempts will be limited to 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supraglottic Airway Leak Pressure</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 airway pressure at which an airway leak is observed after placement of the supraglottic airway</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fiberoptic Grade of Laryngeal View</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Maneuvers</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 during tracheal intubation 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 the airway, such as sore throat or hoarseness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Placement of Supraglottic Airway</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 to placement of supraglottic device will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Attempts to Place the Tracheal Tube</measure>
    <time_frame>participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours</time_frame>
    <description>Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Tracheal Intubation in Children</condition>
  <arm_group>
    <arm_group_label>air-Q</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the air-Q with size based on manufacturer recommendations of body weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>i-gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the i-gel with size based on manufacturer recommendations of body weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-gel</intervention_name>
    <description>Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.</description>
    <arm_group_label>i-gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>air-Q</intervention_name>
    <description>Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.</description>
    <arm_group_label>air-Q</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children undergoing general anesthesia requiring tracheal intubation&#xD;
&#xD;
          -  Age one month to six years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class IV, V&#xD;
&#xD;
          -  Children receiving emergent surgery&#xD;
&#xD;
          -  History or high suspicion of a difficult airway&#xD;
&#xD;
          -  Active upper respiratory tract infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>6 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>
  <location>
    <facility>
      <name>Anne &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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.</citation>
    <PMID>22074079</PMID>
  </reference>
  <reference>
    <citation>Sohn LE, Jagannathan N, Sequera-Ramos L, Sawardekar A, Schaldenbrand K, De Oliveira GS. A randomised comparison of free-handed vs air-Q assisted fibreoptic-guided tracheal intubation in children &lt; 2 years of age. Anaesthesia. 2014 Jul;69(7):723-8. doi: 10.1111/anae.12667. Epub 2014 May 2.</citation>
    <PMID>24797607</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>
  <reference>
    <citation>Abukawa Y, Hiroki K, Ozaki M. Initial experience of the i-gel supraglottic airway by the residents in pediatric patients. J Anesth. 2012 Jun;26(3):357-61. doi: 10.1007/s00540-011-1322-1. Epub 2012 Feb 7.</citation>
    <PMID>22310833</PMID>
  </reference>
  <reference>
    <citation>Foucher-Lezla A, Lehousse T, Monrigal JP, Granry JC, Beydon L. Fibreoptic assessment of laryngeal positioning of the paediatric supraglottic airway device I-Gel. Eur J Anaesthesiol. 2013 Jul;30(7):441-2. doi: 10.1097/EJA.0b013e32835f9969. No abstract available.</citation>
    <PMID>23571478</PMID>
  </reference>
  <reference>
    <citation>Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel supraglottic airway device in children. Paediatr Anaesth. 2012 Aug;22(8):765-71. doi: 10.1111/j.1460-9592.2012.03893.x. Epub 2012 Jun 1.</citation>
    <PMID>22672411</PMID>
  </reference>
  <reference>
    <citation>Jagannathan N, Sommers K, Sohn LE, Sawardekar A, Shah RD, Mukherji II, Miller S, Voronov P, Seraphin S. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children. Paediatr Anaesth. 2013 Feb;23(2):127-33. doi: 10.1111/pan.12078. Epub 2012 Nov 27.</citation>
    <PMID>23189931</PMID>
  </reference>
  <reference>
    <citation>Emmerich M, Tiesmeier J. The I-gel supraglottic airway: a useful tool in case of difficult fiberoptic intubation. Minerva Anestesiol. 2012 Oct;78(10):1169-70. No abstract available.</citation>
    <PMID>23059523</PMID>
  </reference>
  <reference>
    <citation>Kim YL, Seo DM, Shim KS, Kim EJ, Lee JH, Lee SG, Ban JS. Successful tracheal intubation using fiberoptic bronchoscope via an I-gel supraglottic airway in a pediatric patient with Goldenhar syndrome -A case report-. Korean J Anesthesiol. 2013 Jul;65(1):61-5. doi: 10.4097/kjae.2013.65.1.61. Epub 2013 Jul 19.</citation>
    <PMID>23904941</PMID>
  </reference>
  <reference>
    <citation>Kim MS, Oh JT, Min JY, Lee KH, Lee JR. A randomised comparison of the i-gel and the Laryngeal Mask Airway Classic in infants. Anaesthesia. 2014 Apr;69(4):362-7. doi: 10.1111/anae.12592.</citation>
    <PMID>24641642</PMID>
  </reference>
  <reference>
    <citation>Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.</citation>
    <PMID>22971118</PMID>
  </reference>
  <reference>
    <citation>Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Can J Anaesth. 2001 Apr;48(4):413-7. doi: 10.1007/BF03014975.</citation>
    <PMID>11339788</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 22, 2014</last_update_submitted>
  <last_update_submitted_qc>October 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2014</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>fiberoptic guided tracheal intubation</keyword>
  <keyword>air-Q</keyword>
  <keyword>i-gel</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/NCT02189590
org study id: I-gel versus air-Q
nct id: NCT02189590
lead sponsor: 
has dmc: No
The purpose of this study is to determine if there is a difference in time for successful
      fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for
      fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be
      performed by residents in training. The primary outcome is of time for successful tracheal
      intubation. The investigators hypothesize that residents will intubate the trachea faster
      when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic
      airway device, fiberoptic grade of laryngeal view, time for device removal after intubation,
      and peri-operative complications will also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Care Provider)
measure: Time to Successful Tracheal Intubation
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation
measure: Ease of Placement of Supraglottic Airway
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 device ranging from 1 (easy) to 4 (difficult).
measure: Number of Attempts to Place the Supraglottic Device
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Number of attempts will be limited to 3
measure: Supraglottic Airway Leak Pressure
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: The airway pressure at which an airway leak is observed after placement of the supraglottic airway
measure: Fiberoptic Grade of Laryngeal View
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system
measure: Airway Maneuvers
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 during tracheal intubation 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 the airway, such as sore throat or hoarseness.
measure: Time to Placement of Supraglottic Airway
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Time to placement of supraglottic device will be measured.
measure: Number of Attempts to Place the Tracheal Tube
time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
description: Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3
arm group label: air-Q
arm group type: Experimental
description: Patients will receive the air-Q with size based on manufacturer recommendations of body weight
arm group label: i-gel
arm group type: Experimental
description: Patients will receive the i-gel with size based on manufacturer recommendations of body weight
intervention type: Device
intervention name: i-gel
description: Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
arm group label: i-gel
intervention type: Device
intervention name: air-Q
description: Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
arm group label: air-Q
criteria: 
gender: All
minimum age: 1 Month
maximum age: 6 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
facility: 
country: United States
citation: Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.
PMID: 22074079
citation: Sohn LE, Jagannathan N, Sequera-Ramos L, Sawardekar A, Schaldenbrand K, De Oliveira GS. A randomised comparison of free-handed vs air-Q assisted fibreoptic-guided tracheal intubation in children < 2 years of age. Anaesthesia. 2014 Jul;69(7):723-8. doi: 10.1111/anae.12667. Epub 2014 May 2.
PMID: 24797607
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
citation: Abukawa Y, Hiroki K, Ozaki M. Initial experience of the i-gel supraglottic airway by the residents in pediatric patients. J Anesth. 2012 Jun;26(3):357-61. doi: 10.1007/s00540-011-1322-1. Epub 2012 Feb 7.
PMID: 22310833
citation: Foucher-Lezla A, Lehousse T, Monrigal JP, Granry JC, Beydon L. Fibreoptic assessment of laryngeal positioning of the paediatric supraglottic airway device I-Gel. Eur J Anaesthesiol. 2013 Jul;30(7):441-2. doi: 10.1097/EJA.0b013e32835f9969. No abstract available.
PMID: 23571478
citation: Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel supraglottic airway device in children. Paediatr Anaesth. 2012 Aug;22(8):765-71. doi: 10.1111/j.1460-9592.2012.03893.x. Epub 2012 Jun 1.
PMID: 22672411
citation: Jagannathan N, Sommers K, Sohn LE, Sawardekar A, Shah RD, Mukherji II, Miller S, Voronov P, Seraphin S. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children. Paediatr Anaesth. 2013 Feb;23(2):127-33. doi: 10.1111/pan.12078. Epub 2012 Nov 27.
PMID: 23189931
citation: Emmerich M, Tiesmeier J. The I-gel supraglottic airway: a useful tool in case of difficult fiberoptic intubation. Minerva Anestesiol. 2012 Oct;78(10):1169-70. No abstract available.
PMID: 23059523
citation: Kim YL, Seo DM, Shim KS, Kim EJ, Lee JH, Lee SG, Ban JS. Successful tracheal intubation using fiberoptic bronchoscope via an I-gel supraglottic airway in a pediatric patient with Goldenhar syndrome -A case report-. Korean J Anesthesiol. 2013 Jul;65(1):61-5. doi: 10.4097/kjae.2013.65.1.61. Epub 2013 Jul 19.
PMID: 23904941
citation: Kim MS, Oh JT, Min JY, Lee KH, Lee JR. A randomised comparison of the i-gel and the Laryngeal Mask Airway Classic in infants. Anaesthesia. 2014 Apr;69(4):362-7. doi: 10.1111/anae.12592.
PMID: 24641642
citation: Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
PMID: 22971118
citation: Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Can J Anaesth. 2001 Apr;48(4):413-7. doi: 10.1007/BF03014975.
PMID: 11339788
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