Clinical trial NCT04253886: Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation
Official title: Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovassapian VS Fekry Airways
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of intubation
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Advancing the endotracheal tube over the bronchoscope
timeFrame: Up to 24 hours
measure: Percentage of success of endotracheal tube insertion
timeFrame: Up to 24 hours
measure: Removal of the bronchoscope
timeFrame: Up to 24 hours
measure: Complications
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Mohamed Ismail Youssef
Study officials:
affiliation: Cairo University
name: Randa Badawi, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Maha M Ismail Youssef, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Sara Farouk Habib, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Eman A Ahmed, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
References: