Clinical trial NCT04450121: Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients
Official title: Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fekry VS the Air-Q Intubating Airways
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endoscopy insertion time
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
Secondary outcomes:
measure: ITHIN Intubation time
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
measure: Grade of endoscopic view
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
measure: Success rate of intubation from 1st trial
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
measure: Score of success of endotracheal intubation
timeFrame: Withen 15 seconds from induction og Generel Anesthesia till Study Completion
measure: Number of intubation and device insertion attempts
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
measure: Complications
timeFrame: Withen 15 seconds from induction og Generel Anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Mohamed Ismail Youssef
Study officials:
affiliation: Cairo University
name: Randa Badawi, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Maha M Ismail Youssef, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed Moamen Mahmoud, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hany M El-Hadi Shoukat, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
References: