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Completed

NCT Number: NCT04253886

Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation

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 Ovassapian Fibreoptic Intubating Airway (Kendall, Argyle, New York, New York, USA) and Fekry Oral Intubating Airway (Ameco Tech, Cairo, Egypt).

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Key information

Conditions

Ovassapian VS Fekry Airways

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maha Mohamed Ismail Youssef

Cairo, 11451, Egypt

About this study

Ovassapian Fibreoptic Intubating Airway :

The Ovassapian Fibreoptic Intubating Airway has a flat lingual surface that widens distally. This provides better retraction of the tongue to prevent it and the soft tissues of the anterior pharyngeal wall from herniating around the side of the airway. The airway has a pair of vertical sidewalls and two pairs of curved guide walls at its proximal section. These walls are separated by a gap which allows removal of the airway after intubation has been completed.

Fekry airway:

● It has two parts are: Airway body& Special connector

  • Airway body consists of:
  • Flange → it is the buccal end it is 7 cm wide to prevent it from moving deeper into mouth & may also serve to fix airway in place.
  • Bite Portion → it is straight & fits between teeth &oral cavity.
  • Oral straight part → open anterior lingual part; it varies in length according to size
  • Pharyngeal curved part → extends backwards to correspond the shape oropharynx and ends below laryngeal inlet.
  • The connector: it is a special type (two sizes: adult and pediatric) can attach to all ventilating machines& it has a teeth rest act as a bite block.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA 1 to3,
  • Aged 18 to 60 years
  • Who presented for elective surgery requiring tracheal intubation

Exclusion criteria

  • All patients with a past history of difficult tracheal intubation
  • Patients with signs of possible difficult tracheal intubation (including modified Mallampati score 3 or 4
  • Limited mouth opening, thyromental distance < 4 cm, limited neck movement or upper airway disease

Treatment and study plan

Ovassapian Fibreoptic Intubating Airway

Device

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 Ovassapian Fibreoptic Intubating Airway (Kendall, Argyle, New York, New York, USA) and Fekry Oral Intubating Airway (Ameco Tech, Cairo, Egypt).

Other names: Fekry airway

Primary outcomes

  1. Time of intubation

    Time frame: Up to 24 hours

    Success rate of Time of intubation

Secondary outcomes

  1. Advancing the endotracheal tube over the bronchoscope

    Time frame: Up to 24 hours

    Easiness of advancing the endotracheal tube over the bronchoscope

  2. Percentage of success of endotracheal tube insertion

    Time frame: Up to 24 hours

    Percentage of success of endotracheal tube insertion from 1st trial in the shortest time

  3. Removal of the bronchoscope

    Time frame: Up to 24 hours

    Easiness of removal of the bronchoscope after intubation.

  4. Complications

    Time frame: Up to 24 hours

    Incidence of complications

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 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.