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

NCT ID: NCT04450121

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-10-03

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.

Conditions

Fekry VS the Air-Q Intubating Airways

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

GA (n =22)

Patients will be intubated using Air-Q airway

Group Type: ACTIVE_COMPARATOR

Patients will be intubated using Air-Q airway

Intervention Type: DEVICE

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)

GF (n =22)

Patients will be intubated using Fekry airway

Group Type: ACTIVE_COMPARATOR

Patients will be intubated using Air-Q airway

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randa Badawi, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Maha M Ismail Youssef, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Ahmed Moamen Mahmoud, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Hany M El-Hadi Shoukat, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Ahmed Abdalla Mohamed, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Maha Mohamed Ismail Youssef

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N 54-2018/Ms

Identifier Type: -

Identifier Source: org_study_id