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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253886
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdalla, Cairo University

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).


Condition or disease Intervention/treatment Phase
Ovassapian VS Fekry Airways Device: Ovassapian Fibreoptic Intubating Airway Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Investigator)
Masking Description: Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
Primary Purpose: Diagnostic
Official Title: Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation
Actual Study Start Date : January 5, 2019
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : November 9, 2019

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 Name: Fekry airway

Active Comparator: 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.
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 Name: Fekry airway




Primary Outcome Measures :
  1. Time of intubation [ Time Frame: Up to 24 hours ]
    Success rate of Time of intubation


Secondary Outcome Measures :
  1. Advancing the endotracheal tube over the bronchoscope [ Time Frame: Up to 24 hours ]
    Easiness of advancing the endotracheal tube over the bronchoscope

  2. Percentage of success of endotracheal tube insertion [ Time Frame: Up to 24 hours ]
    Percentage of success of endotracheal tube insertion from 1st trial in the shortest time

  3. Removal of the bronchoscope [ Time Frame: Up to 24 hours ]
    Easiness of removal of the bronchoscope after intubation.

  4. Complications [ Time Frame: Up to 24 hours ]
    Incidence of complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253886


Locations
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Egypt
Maha Mohamed Ismail Youssef
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
Investigators
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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
Principal Investigator: Ahmed Abdalla Mohamed, M.D Cairo University
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Responsible Party: Ahmed Abdalla, Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04253886    
Other Study ID Numbers: N 31-2018/Ms
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No