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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04253886
Enrollment
350
Registered
2020-02-05
Start date
2019-01-05
Completion date
2019-11-09
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovassapian VS Fekry Airways

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.

Interventions

DEVICEOvassapian 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).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Masking description

Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time of intubationUp to 24 hoursSuccess rate of Time of intubation

Secondary

MeasureTime frameDescription
Advancing the endotracheal tube over the bronchoscopeUp to 24 hoursEasiness of advancing the endotracheal tube over the bronchoscope
Percentage of success of endotracheal tube insertionUp to 24 hoursPercentage of success of endotracheal tube insertion from 1st trial in the shortest time
Removal of the bronchoscopeUp to 24 hoursEasiness of removal of the bronchoscope after intubation.
ComplicationsUp to 24 hoursIncidence of complications

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026