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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04450121
Enrollment
44
Registered
2020-06-29
Start date
2019-01-09
Completion date
2019-10-03
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fekry VS the Air-Q Intubating Airways

Brief 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).

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.

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)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Masking description

Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.

Intervention model description

Comparison between the two airways regarding: 1. Time to Glottic view. 2. Grade of bronchoscopic view. 3. Success of intubation from 1st trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Endoscopy insertion timeWithen 15 seconds from induction og Generel AnesthesiaTime 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

Secondary

MeasureTime frameDescription
Grade of endoscopic viewWithen 15 seconds from induction og Generel AnesthesiaEndoscopic view grading
ITHIN Intubation timeWithen 15 seconds from induction og Generel AnesthesiaTiming of complete intubation
Success rate of intubation from 1st trialWithen 15 seconds from induction og Generel Anesthesia1st trial Success
Number of intubation and device insertion attemptsWithen 15 seconds from induction og Generel AnesthesiaAttempts Number of intubation and device insertion
ComplicationsWithen 15 seconds from induction og Generel AnesthesiaCoughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2\<92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.
Score of success of endotracheal intubationWithen 15 seconds from induction og Generel Anesthesia till Study CompletionEndotracheal intubation Score of success

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026