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).

Study Overview

• Status: Completed
• Conditions: Ovassapian VS Fekry Airways
• Intervention / Treatment: Device: Ovassapian Fibreoptic Intubating Airway

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 Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Maha Mohamed Ismail Youssef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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	Device: Ovassapian Fibreoptic Intubating Airway; 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
Active Comparator: Group B; 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 frommoving 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 sizePharyngeal 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.	Device: Ovassapian Fibreoptic Intubating Airway; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of intubation	Success rate of Time of intubation	Up to 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Randa Badawi, M.D, Cairo University; Principal Investigator: Maha M Ismail Youssef, M.D, Cairo University; Principal Investigator: Sara Farouk Habib, M.D, Cairo University; Principal Investigator: Eman A Ahmed, M.Sc., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): November 9, 2019

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: N 31-2018/Ms

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No