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

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).

Study Overview

• Status: Completed
• Conditions: Fekry VS the Air-Q Intubating Airways
• Intervention / Treatment: Device: Patients will be intubated using Air-Q airway

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Maha Mohamed Ismail Youssef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GA (n =22); Patients will be intubated using Air-Q airway	Device: Patients 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)
Active Comparator: GF (n =22); Patients will be intubated using Fekry airway	Device: Patients 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Withen 15 seconds from induction og Generel Anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ITHIN Intubation time	Timing of complete intubation	Withen 15 seconds from induction og Generel Anesthesia
Grade of endoscopic view	Endoscopic view grading	Withen 15 seconds from induction og Generel Anesthesia
Success rate of intubation from 1st trial	1st trial Success	Withen 15 seconds from induction og Generel Anesthesia
Score of success of endotracheal intubation	Endotracheal intubation Score of success	Withen 15 seconds from induction og Generel Anesthesia till Study Completion
Number of intubation and device insertion attempts	Attempts Number of intubation and device insertion	Withen 15 seconds from induction og Generel Anesthesia
Complications	Coughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2<92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.	Withen 15 seconds from induction og Generel Anesthesia

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Randa Badawi, M.D, Cairo university; Principal Investigator: Maha M Ismail Youssef, M.D, Cairo university; Principal Investigator: Ahmed Moamen Mahmoud, M.Sc, Cairo university; Principal Investigator: Hany M El-Hadi Shoukat, M.D, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: N 54-2018/Ms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till Publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No