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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovassapian VS Fekry Airways

Intervention / Treatment
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* Device: Ovassapian Fibreoptic Intubating Airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Either the Fekry Oral Airway Intubator (Ameco Tech, Cairo, Egypt) or the Ovassapian Fibreoptic Intubating Airway (Kendall Sheridan, Argyle, NY) will be inserted into the mouth in random order, and the patient's lungs ventilated by bag and facemask with 100% oxygen and 1-1.5% isoflurane. Blinding will be impossible in this study as the operator has to see the airway through the fibrescope in order to perform the assessment. After confirmation of full neuromuscular blockade, a bronchoscope with a preloaded tracheal tube will be then inserted through the airway for bronchoscopic assessment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* 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).<br>* Other names: Fekry airway;|
| Active Comparator: Group B<br>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. | Device: Ovassapian Fibreoptic Intubating Airway<br>* 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).<br>* Other names: Fekry airway;|

What is the study measuring?
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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 |