<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/NCT04450121</url>
  </required_header>
  <id_info>
    <org_study_id>N 54-2018/Ms</org_study_id>
    <nct_id>NCT04450121</nct_id>
  </id_info>
  <brief_title>Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients</brief_title>
  <official_title>Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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 fibreoptic bronchoscope remains one of the most important methods of intubating patients&#xD;
      particularly when there is difficulty with intubation.&#xD;
&#xD;
      Facilitating fiberoptic oropharyngeal intubation procedure, specific airways have been&#xD;
      devised to push the tongue anteriorly to clear a passage for the fibrescope into the trachea.&#xD;
&#xD;
      Of these airways the Air-Q Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA)&#xD;
      and Fekry Oral Intubating Airway (Ameco Technology, Cairo, Egypt).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Air-Q Intubating Laryngeal Airway (Air-Q):&#xD;
&#xD;
      The Air-Q™ Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) is a SAD that&#xD;
      was designed primarily to act as a conduit for the passage of a cuffed tracheal tube during&#xD;
      tracheal intubation (1), Compared with the LMA, the Air-Q has a shorter silicon airway tube&#xD;
      that allows an easy visualization of vocal cords and intubation and removal of the device&#xD;
      after tracheal tube insertion. The device has a removable color coded connector, allows&#xD;
      intubation through the airway tube. The device is also wider, C-curved and has an integrated&#xD;
      bite block which makes it easier to place reinforces the tube and diminishes the need for a&#xD;
      separate bite block, with an elevation ramp that facilitates intubation and directs the tube&#xD;
      toward the laryngeal inlet. It also has a built-up mask for improved seal. All of these&#xD;
      features facilitate the passage of the tracheal tube through the device and into the trachea.&#xD;
&#xD;
      Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):&#xD;
&#xD;
      Several modifications of oropharyngeal airways aiming to allow facilitation of intubation and&#xD;
      easy removal of the airway after placement of ETT.&#xD;
&#xD;
      In Fekry airway, modification of the Williams airway facilitates the airway removal after ETT&#xD;
      insertion without need to remove the international part of the ETT (this reduce risk of ETT&#xD;
      dislodgement during airway removal).&#xD;
&#xD;
      The modification made to the Williams airway is that the roof of the proximal cylindrical&#xD;
      tunnel is opened from its upper part to allow one step insertion of the tube. There is no&#xD;
      need for removal of the tube connector after tube insertion. It allows passage of the suction&#xD;
      catheter and may allow oxygen insufflations through a catheter.&#xD;
&#xD;
      As mastering airway management in difficult cases is an essential job to anesthesiologist, we&#xD;
      think it is important to find an easy adjunct to this hard job.&#xD;
&#xD;
      investigators hypothesized that Fekry airway could offer a better conduit to flexible&#xD;
      fiberoptic intubation rather than the air-Q device, because it needs less experience in how&#xD;
      to use, less intubation time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">October 3, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</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>
    <intervention_model_description>Comparison between the two airways regarding:&#xD;
Time to Glottic view.&#xD;
Grade of bronchoscopic view.&#xD;
Success of intubation from 1st trial.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Endoscopy insertion time</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>Time from introducing the tip of scope through the proximal end of the airway device or mouth until the visualization of carina (multiple attempts will be added to compute this time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ITHIN Intubation time</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>Timing of complete intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of endoscopic view</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>Endoscopic view grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of intubation from 1st trial</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>1st trial Success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of success of endotracheal intubation</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia till Study Completion</time_frame>
    <description>Endotracheal intubation Score of success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of intubation and device insertion attempts</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>Attempts Number of intubation and device insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Withen 15 seconds from induction og Generel Anesthesia</time_frame>
    <description>Coughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2&lt;92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Fekry VS the Air-Q Intubating Airways</condition>
  <arm_group>
    <arm_group_label>GA (n =22)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be intubated using Air-Q airway</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GF (n =22)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be intubated using Fekry airway</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Patients will be intubated using Air-Q airway</intervention_name>
    <description>Both groups:&#xD;
Grade 1: Split airway provides an unobstructed path for bronchoscope from mouth to glottis.&#xD;
Grade 2: Tongue rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.&#xD;
Grade 3: Epiglottis rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.&#xD;
Grade 4: Tongue and epiglottis rest against posterior pharyngeal wall, both causing partial obstruction to bronchoscope.&#xD;
Grade 5: Tongue rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure).&#xD;
Grade 6: Epiglottis rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure)</description>
    <arm_group_label>GA (n =22)</arm_group_label>
    <arm_group_label>GF (n =22)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years old.&#xD;
&#xD;
          -  Of both sexes.&#xD;
&#xD;
          -  With American Society of Anaesthesiologists (ASA) physical status class I-ll.&#xD;
&#xD;
          -  Scheduled for elective surgery under general anesthesia requiring ETT placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Patient that has any documented or suspected difficult airway or neck or upper&#xD;
             respiratory tract abnormalities, facial deformities that invalidate Ganzouri airway&#xD;
             score.&#xD;
&#xD;
          -  Patient that has any active cardiac or chest problem and risk of aspiration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randa Badawi, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maha M Ismail Youssef, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Moamen Mahmoud, M.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hany M El-Hadi Shoukat, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Abdalla Mohamed, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maha Mohamed Ismail Youssef</name>
      <address>
        <city>Cairo</city>
        <zip>11451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdalla</investigator_full_name>
    <investigator_title>Professor of Anesthesia &amp;I.C.U and Pain Clinic, Cairo University</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Till Publication</ipd_description>
  </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/NCT04450121
org study id: N 54-2018/Ms
nct id: NCT04450121
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The fibreoptic bronchoscope remains one of the most important methods of intubating patients
      particularly when there is difficulty with intubation.

      Facilitating fiberoptic oropharyngeal intubation procedure, specific airways have been
      devised to push the tongue anteriorly to clear a passage for the fibrescope into the trachea.

      Of these airways the Air-Q Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA)
      and Fekry Oral Intubating Airway (Ameco Technology, Cairo, Egypt).
The Air-Q Intubating Laryngeal Airway (Air-Q):

      The Air-Q™ Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) is a SAD that
      was designed primarily to act as a conduit for the passage of a cuffed tracheal tube during
      tracheal intubation (1), Compared with the LMA, the Air-Q has a shorter silicon airway tube
      that allows an easy visualization of vocal cords and intubation and removal of the device
      after tracheal tube insertion. The device has a removable color coded connector, allows
      intubation through the airway tube. The device is also wider, C-curved and has an integrated
      bite block which makes it easier to place reinforces the tube and diminishes the need for a
      separate bite block, with an elevation ramp that facilitates intubation and directs the tube
      toward the laryngeal inlet. It also has a built-up mask for improved seal. All of these
      features facilitate the passage of the tracheal tube through the device and into the trachea.

      Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):

      Several modifications of oropharyngeal airways aiming to allow facilitation of intubation and
      easy removal of the airway after placement of ETT.

      In Fekry airway, modification of the Williams airway facilitates the airway removal after ETT
      insertion without need to remove the international part of the ETT (this reduce risk of ETT
      dislodgement during airway removal).

      The modification made to the Williams airway is that the roof of the proximal cylindrical
      tunnel is opened from its upper part to allow one step insertion of the tube. There is no
      need for removal of the tube connector after tube insertion. It allows passage of the suction
      catheter and may allow oxygen insufflations through a catheter.

      As mastering airway management in difficult cases is an essential job to anesthesiologist, we
      think it is important to find an easy adjunct to this hard job.

      investigators hypothesized that Fekry airway could offer a better conduit to flexible
      fiberoptic intubation rather than the air-Q device, because it needs less experience in how
      to use, less intubation time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison between the two airways regarding:
Time to Glottic view.
Grade of bronchoscopic view.
Success of intubation from 1st trial.
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
masking description: Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
measure: Endoscopy insertion time
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: Time from introducing the tip of scope through the proximal end of the airway device or mouth until the visualization of carina (multiple attempts will be added to compute this time
measure: ITHIN Intubation time
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: Timing of complete intubation
measure: Grade of endoscopic view
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: Endoscopic view grading
measure: Success rate of intubation from 1st trial
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: 1st trial Success
measure: Score of success of endotracheal intubation
time frame: Withen 15 seconds from induction og Generel Anesthesia till Study Completion
description: Endotracheal intubation Score of success
measure: Number of intubation and device insertion attempts
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: Attempts Number of intubation and device insertion
measure: Complications
time frame: Withen 15 seconds from induction og Generel Anesthesia
description: Coughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2<92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.
arm group label: GA (n =22)
arm group type: Active Comparator
description: Patients will be intubated using Air-Q airway
arm group label: GF (n =22)
arm group type: Active Comparator
description: Patients will be intubated using Fekry airway
intervention type: Device
intervention name: Patients will be intubated using Air-Q airway
description: Both groups:
Grade 1: Split airway provides an unobstructed path for bronchoscope from mouth to glottis.
Grade 2: Tongue rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
Grade 3: Epiglottis rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
Grade 4: Tongue and epiglottis rest against posterior pharyngeal wall, both causing partial obstruction to bronchoscope.
Grade 5: Tongue rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure).
Grade 6: Epiglottis rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure)
arm group label: GA (n =22)
arm group label: GF (n =22)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Randa Badawi, M.D
role: Principal Investigator
affiliation: Cairo University
last name: Maha M Ismail Youssef, M.D
role: Principal Investigator
affiliation: Cairo University
last name: Ahmed Moamen Mahmoud, M.Sc
role: Principal Investigator
affiliation: Cairo University
last name: Hany M El-Hadi Shoukat, M.D
role: Principal Investigator
affiliation: Cairo University
last name: Ahmed Abdalla Mohamed, M.D
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdalla
investigator title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
sharing ipd: Undecided
ipd description: Till Publication