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CompletedNCT04450121Updated Jun 30, 2020

Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients

An interventional study of Patients will be intubated using Air-Q airway in Fekry VS the Air-Q Intubating Airways, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Fekry VS the Air-Q Intubating Airways
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients aged ≥18 years old.
  • Of both sexes.
  • With American Society of Anaesthesiologists (ASA) physical status class I-ll.
  • Scheduled for elective surgery under general anesthesia requiring ETT placement.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • Patient that has any documented or suspected difficult airway or neck or upper respiratory tract abnormalities, facial deformities that invalidate Ganzouri airway score.
  • Patient that has any active cardiac or chest problem and risk of aspiration.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    GA (n =22)

    Patients will be intubated using Air-Q airway

    Device: Patients will be intubated using Air-Q airway

  • Active comparator
    GF (n =22)

    Patients will be intubated using Fekry airway

    Device: Patients will be intubated using Air-Q airway

Interventions

  • DevicePatients will be intubated using Air-Q airway

    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)

06

What researchers measure

Primary outcomes

  1. Endoscopy insertion time

    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

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

Secondary outcomes

  1. ITHIN Intubation time

    Timing of complete intubation

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

  2. Grade of endoscopic view

    Endoscopic view grading

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

  3. Success rate of intubation from 1st trial

    1st trial Success

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

  4. Score of success of endotracheal intubation

    Endotracheal intubation Score of success

    Time frame: Withen 15 seconds from induction og Generel Anesthesia till Study Completion

  5. Number of intubation and device insertion attempts

    Attempts Number of intubation and device insertion

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

  6. Complications

    Coughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2\<92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

07

Study locations

1 site
  • Maha Mohamed Ismail Youssef
    Cairo, 11451, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — Till Publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04450121
Lead sponsor
Cairo University
Responsible party
Ahmed Abdalla (Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University) — Principal investigator
First posted
Jun 29, 2020
Start date
Jan 9, 2019
Primary completion
Sep 15, 2019
Completion
Oct 3, 2019
Last update
Jun 30, 2020

Study contacts

Randa Badawi, M.D
principal investigator · Cairo University
Maha M Ismail Youssef, M.D
principal investigator · Cairo University
Ahmed Moamen Mahmoud, M.Sc
principal investigator · Cairo University
Hany M El-Hadi Shoukat, M.D
principal investigator · Cairo University
Ahmed Abdalla Mohamed, M.D
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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