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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-05

Study Completion Date

2019-11-09

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).

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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

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.

Conditions

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Ovassapian VS Fekry Airways

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ovassapian Fibreoptic Intubating Airway

Intervention Type DEVICE

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).

Group B

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 Type ACTIVE_COMPARATOR

Ovassapian Fibreoptic Intubating Airway

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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Fekry airway

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes