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

Not Applicable

Completed

• Conditions: Ovassapian VS Fekry Airways
• Interventions: Device: Ovassapian Fibreoptic Intubating Airway

• Registration Number: NCT04253886
• Lead Sponsor: Cairo University

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

Detailed 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.

Study Timeline

• Study Start: 2019-01-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-11-09
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-27
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ovassapian Fibreoptic Intubating Airway	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.
Group A	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

Primary Outcome Measures

Name	Time	Method
Time of intubation	Up to 24 hours	Success rate of Time of intubation

Secondary Outcome Measures

Name	Time	Method
Advancing the endotracheal tube over the bronchoscope	Up to 24 hours	Easiness of advancing the endotracheal tube over the bronchoscope
Removal of the bronchoscope	Up to 24 hours	Easiness of removal of the bronchoscope after intubation.
Percentage of success of endotracheal tube insertion	Up to 24 hours	Percentage of success of endotracheal tube insertion from 1st trial in the shortest time
Complications	Up to 24 hours	Incidence of complications

Trial Locations

Locations (1)

Maha Mohamed Ismail Youssef; 🇪🇬 Cairo, Egypt