<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/NCT02975466</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1484</org_study_id>
    <nct_id>NCT02975466</nct_id>
  </id_info>
  <brief_title>Comparing the Efficiency of Three Third-generation Supraglottic Airways as an Intubation Route</brief_title>
  <official_title>Randomized Controlled Trial Comparing the Efficiency of Three Third Generation Supraglottic Airways as an Intubation Route</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Sherbrooke</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>
      A &quot;can't intubate, can't oxygenate&quot; situation is life-threatening and the physician must be&#xD;
      prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is&#xD;
      associated with complications. In both of these situation and as recommend by different&#xD;
      societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an&#xD;
      intubation conduit to ease the airway access. The objective of this randomized controlled&#xD;
      trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the&#xD;
      fastest intubation time in an adult population, with the objective of minimizing&#xD;
      complications related to these situations. The investigators will conduct a three-arm trial&#xD;
      to compare different outcomes related to the installation of the SGA and its use as an&#xD;
      intubation conduit. The results of this trial will inform the anesthesiologist on which&#xD;
      device to use on to have close in case of airway emergencies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time for intubation</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>This outcome corresponds to the time required to intubate with endotracheal tube (ET) through the supra-glottic airway device. The timer will be started when the flexible fiberoptic intubation scope is inserted in the SGA, and will be stopped when the air cuff of the ET is inflated inside the trachea and carbon dioxide (CO2) is obtained. This outcome will be assessed by the either the performer or second person responsible for data collection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success of intubation on first attempt</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>This outcome is dichotomic and represents success of intubation through the SGA on the first attempt. An attempt will be defined as any lowering of the ET towards the glottis. Thus, any raise of the ET to its original position on the fiberoptic intubation scope will be considered as a failed attempt. Similarly, any removal of the fiberoptic scope from the SGA will be considered as a failed attempt, regardless of an attempt to lower the ET. This primary outcome is dichotomous and answers to the question: &quot;Was the first attempt successful?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of intubation through the SGA</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>Regardless of the number of attempts, this outcome will be considered positive if the ET penetrated the trachea, the air cuff was inflated and capnography is positive, sustained and with normal values. A failed intubation would be, for example, to leave the SGA in place for the whole surgery or to remove the SGA to complete the endotracheal intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts for intubation</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>For example, the ET is lowered and does not enter the glottis, and is raised up again while the scope is removed from the SGA : &quot;one&quot; failed attempt will be noted. If the scope is entered in the SGA, no attempt to lower the ET and the scope is removed : &quot;one&quot; failed attempt will also be noted. However, if the scope is inserted in the SGA, the ET is lowered a first time and raised on the scope, and the ET is lowered a second time and raised again on the scope, &quot;two&quot; failed attempts will be considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for whole procedure</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>The time for whole procedure corresponds to the sum of the time required for installation of the SGA device and the time required for intubation through the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laryngeal view grades</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>An evaluation of the laryngeal view on the first attempt of fibroscopy will be evaluated by the attending anesthesiologist with the following scale :&#xD;
Grade 1 : whole vocal cords are seen, the epiglottis is not seen at all&#xD;
Grade 2 : larynx plus the posterior surface of epiglottis are seen&#xD;
Grade 3 : the anterior tip of the epiglottis is seen&#xD;
Grade 4 : the anterior tip of the epiglottis is seen and encroaching on the view of vocal cords obstructing &lt;50% of view&#xD;
Grade 5 : the epiglottis is completely obstructing the SGA opening, no view is seen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Easiness of insertion and ventilation of the SGA</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>The easiness of insertion and ventilation will be graded using the following scale, as proposed by Talaat and al. in his trial on Air-Q and Fastrach devices.&#xD;
Easy means obtaining an effective airway, defined as normal chest movement and a square wave capnograph trace, from the first attempt&#xD;
Moderate means obtaining an effective airway in the second or third attempt with some manipulation of the technique of insertion&#xD;
Difficult means failure to obtain an effective airway after three attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Easiness of intubation</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>The easiness of intubation will be subjectively evaluated by the attending anesthesiologist using the following scale:&#xD;
Easy, meaning that railing the ET into the trachea was easy&#xD;
Moderate, meaning that railing the ET needed mild corrective manoeuvers and the procedure was mildly longer than expected&#xD;
Difficult, meaning that railing the ET was considerably longer than expected and that many corrective manœuvres were done, as removing and reinserting the fiberoptic scope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Easiness of removal of the SGA after a completed endotracheal intubation</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>The anesthesiologist will be asked to report a subjective evaluation of the removal of the SGA once the patient is intubated.&#xD;
Easy removal&#xD;
Moderate difficulty&#xD;
Hard&#xD;
Impossible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through study completion, an average of half an hour (no follow-up required)</time_frame>
    <description>The research team will report any adverse events. For example, accidental extubation during the removal of the SGA, blood on the device when removed, desaturation under 90%. As previously mentioned, if the attending anesthesiologist wants to stop the protocol for different reasons, as unsatisfactory ventilation, the standardized manipulations will be stopped and the anesthesiologist will pursue airway management according to his preferences.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Difficult Intubation</condition>
  <arm_group>
    <arm_group_label>AirQ Blocker supra-glottic airway device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients in which the Air-Q Blocker will be used and measured as an intubation conduit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AuraGain supra-glottic airway device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients in which the AuraGain will be used and measured as an intubation conduit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-Gel supra-glottic airway device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients in which the I-Gel will be used and measured as an intubation conduit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of AirQ Blocker and intubation through the device</intervention_name>
    <description>Insertion of the SGA device and evaluation of easiness of endotracheal intubation</description>
    <arm_group_label>AirQ Blocker supra-glottic airway device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of AuraGain and intubation through the device</intervention_name>
    <description>Insertion of the SGA device and evaluation of easiness of endotracheal intubation</description>
    <arm_group_label>AuraGain supra-glottic airway device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of I-Gel and intubation through the device</intervention_name>
    <description>Insertion of the SGA device and evaluation of easiness of endotracheal intubation</description>
    <arm_group_label>I-Gel supra-glottic airway device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  ASA score of 1-3&#xD;
&#xD;
          -  Elective or urgent surgery planned to last at least 30 minutes under general&#xD;
             anesthesia with endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to the use of SGA devices considered by the anesthesiologist&#xD;
             (Uncontrolled gastro-eosophageal reflux, oropharyngeal pathology or gross deformation,&#xD;
             etc.)&#xD;
&#xD;
          -  Any contraindication to the drugs planned by the trial&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe or uncontrolled obstructive pulmonary disease&#xD;
&#xD;
          -  Significant cervical spine anomaly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-José Colas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Sherbrooke (CHUS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Talaat AH, Mostafa AEE, Mohsen ME, Hesham SA. Comparative study between Air-Q and Intubating Laryngeal Mask Airway when used as conduit for fiber-optic. Egyptian Journal of Anaesthesia 30(2), 2013</citation>
  </reference>
  <reference>
    <citation>Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.</citation>
    <PMID>23364566</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Marie-Josee Colas</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <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/NCT02975466
org study id: 2017-1484
nct id: NCT02975466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A "can't intubate, can't oxygenate" situation is life-threatening and the physician must be
      prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is
      associated with complications. In both of these situation and as recommend by different
      societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an
      intubation conduit to ease the airway access. The objective of this randomized controlled
      trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the
      fastest intubation time in an adult population, with the objective of minimizing
      complications related to these situations. The investigators will conduct a three-arm trial
      to compare different outcomes related to the installation of the SGA and its use as an
      intubation conduit. The results of this trial will inform the anesthesiologist on which
      device to use on to have close in case of airway emergencies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time for intubation
time frame: Through study completion, an average of half an hour (no follow-up required)
description: This outcome corresponds to the time required to intubate with endotracheal tube (ET) through the supra-glottic airway device. The timer will be started when the flexible fiberoptic intubation scope is inserted in the SGA, and will be stopped when the air cuff of the ET is inflated inside the trachea and carbon dioxide (CO2) is obtained. This outcome will be assessed by the either the performer or second person responsible for data collection.
measure: Success of intubation on first attempt
time frame: Through study completion, an average of half an hour (no follow-up required)
description: This outcome is dichotomic and represents success of intubation through the SGA on the first attempt. An attempt will be defined as any lowering of the ET towards the glottis. Thus, any raise of the ET to its original position on the fiberoptic intubation scope will be considered as a failed attempt. Similarly, any removal of the fiberoptic scope from the SGA will be considered as a failed attempt, regardless of an attempt to lower the ET. This primary outcome is dichotomous and answers to the question: "Was the first attempt successful?"
measure: Success of intubation through the SGA
time frame: Through study completion, an average of half an hour (no follow-up required)
description: Regardless of the number of attempts, this outcome will be considered positive if the ET penetrated the trachea, the air cuff was inflated and capnography is positive, sustained and with normal values. A failed intubation would be, for example, to leave the SGA in place for the whole surgery or to remove the SGA to complete the endotracheal intubation.
measure: Number of attempts for intubation
time frame: Through study completion, an average of half an hour (no follow-up required)
description: For example, the ET is lowered and does not enter the glottis, and is raised up again while the scope is removed from the SGA : "one" failed attempt will be noted. If the scope is entered in the SGA, no attempt to lower the ET and the scope is removed : "one" failed attempt will also be noted. However, if the scope is inserted in the SGA, the ET is lowered a first time and raised on the scope, and the ET is lowered a second time and raised again on the scope, "two" failed attempts will be considered.
measure: Time for whole procedure
time frame: Through study completion, an average of half an hour (no follow-up required)
description: The time for whole procedure corresponds to the sum of the time required for installation of the SGA device and the time required for intubation through the device.
measure: Laryngeal view grades
time frame: Through study completion, an average of half an hour (no follow-up required)
description: An evaluation of the laryngeal view on the first attempt of fibroscopy will be evaluated by the attending anesthesiologist with the following scale :
Grade 1 : whole vocal cords are seen, the epiglottis is not seen at all
Grade 2 : larynx plus the posterior surface of epiglottis are seen
Grade 3 : the anterior tip of the epiglottis is seen
Grade 4 : the anterior tip of the epiglottis is seen and encroaching on the view of vocal cords obstructing <50% of view
Grade 5 : the epiglottis is completely obstructing the SGA opening, no view is seen
measure: Easiness of insertion and ventilation of the SGA
time frame: Through study completion, an average of half an hour (no follow-up required)
description: The easiness of insertion and ventilation will be graded using the following scale, as proposed by Talaat and al. in his trial on Air-Q and Fastrach devices.
Easy means obtaining an effective airway, defined as normal chest movement and a square wave capnograph trace, from the first attempt
Moderate means obtaining an effective airway in the second or third attempt with some manipulation of the technique of insertion
Difficult means failure to obtain an effective airway after three attempts
measure: Easiness of intubation
time frame: Through study completion, an average of half an hour (no follow-up required)
description: The easiness of intubation will be subjectively evaluated by the attending anesthesiologist using the following scale:
Easy, meaning that railing the ET into the trachea was easy
Moderate, meaning that railing the ET needed mild corrective manoeuvers and the procedure was mildly longer than expected
Difficult, meaning that railing the ET was considerably longer than expected and that many corrective manœuvres were done, as removing and reinserting the fiberoptic scope.
measure: Easiness of removal of the SGA after a completed endotracheal intubation
time frame: Through study completion, an average of half an hour (no follow-up required)
description: The anesthesiologist will be asked to report a subjective evaluation of the removal of the SGA once the patient is intubated.
Easy removal
Moderate difficulty
Hard
Impossible
measure: Adverse events
time frame: Through study completion, an average of half an hour (no follow-up required)
description: The research team will report any adverse events. For example, accidental extubation during the removal of the SGA, blood on the device when removed, desaturation under 90%. As previously mentioned, if the attending anesthesiologist wants to stop the protocol for different reasons, as unsatisfactory ventilation, the standardized manipulations will be stopped and the anesthesiologist will pursue airway management according to his preferences.
arm group label: AirQ Blocker supra-glottic airway device
arm group type: Experimental
description: Group of patients in which the Air-Q Blocker will be used and measured as an intubation conduit.
arm group label: AuraGain supra-glottic airway device
arm group type: Experimental
description: Group of patients in which the AuraGain will be used and measured as an intubation conduit.
arm group label: I-Gel supra-glottic airway device
arm group type: Experimental
description: Group of patients in which the I-Gel will be used and measured as an intubation conduit.
intervention type: Device
intervention name: Insertion of AirQ Blocker and intubation through the device
description: Insertion of the SGA device and evaluation of easiness of endotracheal intubation
arm group label: AirQ Blocker supra-glottic airway device
intervention type: Device
intervention name: Insertion of AuraGain and intubation through the device
description: Insertion of the SGA device and evaluation of easiness of endotracheal intubation
arm group label: AuraGain supra-glottic airway device
intervention type: Device
intervention name: Insertion of I-Gel and intubation through the device
description: Insertion of the SGA device and evaluation of easiness of endotracheal intubation
arm group label: I-Gel supra-glottic airway device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marie-José Colas, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
facility: 
country: Canada
citation: Talaat AH, Mostafa AEE, Mohsen ME, Hesham SA. Comparative study between Air-Q and Intubating Laryngeal Mask Airway when used as conduit for fiber-optic. Egyptian Journal of Anaesthesia 30(2), 2013
citation: Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PMID: 23364566
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Marie-Josee Colas
investigator title: Anesthesiologist
sharing ipd: No