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

Cairo University (CU)

Status: Completed

Conditions: Ovassapian VS Fekry Airways

Treatments: Device: Ovassapian Fibreoptic Intubating Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT04253886

N 31-2018/Ms

Details and patient eligibility

About

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).

Full description

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

1. Airway body consists of:

   1. 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.
   2. Bite Portion → it is straight & fits between teeth &oral cavity.
   3. Oral straight part → open anterior lingual part; it varies in length according to size
   4. Pharyngeal curved part → extends backwards to correspond the shape oropharynx and ends below laryngeal inlet.

2. 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Device: Ovassapian Fibreoptic Intubating Airway

Group B

Active Comparator group

Description:

Fekry airway: ● It has two parts are: Airway body\& Special connector 1. Airway body consists of: 1. Flange → it is the buccal end it is 7 cm wide to prevent it from 2. moving deeper into mouth \& may also serve to fix airway in place. 3. Bite Portion → it is straight \& fits between teeth \&oral cavity. 4. Oral straight part → open anterior lingual part; it varies in length according to size 5. Pharyngeal curved part → extends backwards to correspond the shape oropharynx and ends below laryngeal inlet. 2. 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.

Treatment:

Device: Ovassapian Fibreoptic Intubating Airway