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Completed

NCT Number: NCT04450121

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maha Mohamed Ismail Youssef

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients will be intubated using Air-Q airway

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)

Primary outcomes

  1. Endoscopy insertion time

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

    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

Secondary outcomes

  1. ITHIN Intubation time

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

    Timing of complete intubation

  2. Grade of endoscopic view

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

    Endoscopic view grading

  3. Success rate of intubation from 1st trial

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

    1st trial Success

  4. Score of success of endotracheal intubation

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

    Endotracheal intubation Score of success

  5. Number of intubation and device insertion attempts

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

    Attempts Number of intubation and device insertion

  6. Complications

    Time frame: Withen 15 seconds from induction og Generel Anesthesia

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.