Ovassapian VS Fekry AirwaysNCT04253886
Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation
A study testing Ovassapian Fibreoptic Intubating Airway in people with Ovassapian VS Fekry Airways, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ovassapian VS Fekry Airways
- What is being tested?
- Ovassapian Fibreoptic Intubating Airway
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2019to 9 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 to3,
- Aged 18 to 60 years
- Who presented for elective surgery requiring tracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- 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.
- Conditions
- Ovassapian VS Fekry Airways
- Being tested
- Ovassapian Fibreoptic Intubating Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovassapian Fibreoptic Intubating AirwayDevice
Also called Fekry 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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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 Receives: Device: Ovassapian Fibreoptic Intubating Airway |
| Group B | Active comparator | 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. Receives: Device: Ovassapian Fibreoptic Intubating Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of intubation
Success rate of Time of intubation
Measured: Up to 24 hours
Secondary outcomes (4)
Advancing the endotracheal tube over the bronchoscope
Easiness of advancing the endotracheal tube over the bronchoscope
Measured: 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
Measured: Up to 24 hours
Removal of the bronchoscope
Easiness of removal of the bronchoscope after intubation.
Measured: Up to 24 hours
Complications
Incidence of complications
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Jan 2019
- Primary completion15 Oct 2019
- Study completion9 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovassapian VS Fekry AirwaysStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Randa Badawi, M.D, Principal investigator, Cairo UniversityMaha M Ismail Youssef, M.D, Principal investigator, Cairo UniversitySara Farouk Habib, M.D, Principal investigator, Cairo UniversityEman A Ahmed, M.Sc., Principal investigator, Cairo UniversityAhmed Abdalla Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253886
- Sponsor's protocol ID
- N 31-2018/Ms
- Status last verified
- Jun 2020
- First submitted
- 21 Jan 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT04253886
- Acronym / sponsor ID
- N 31-2018/Ms
- Conditions
- Ovassapian VS Fekry Airways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ovassapian Fibreoptic Intubating AirwayThe 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 B | Active comparator | Device: Ovassapian Fibreoptic Intubating AirwayFekry 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA 1 to3,
- Aged 18 to 60 years
- Who presented for elective surgery requiring tracheal intubation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovassapian Fibreoptic Intubating AirwayAlso: Fekry airwayThe 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). | Device | Group A, Group B |
Primary outcome
Time of intubation
Time frame: Up to 24 hours
Success rate of Time of intubation
4 secondary outcomes
Advancing the endotracheal tube over the bronchoscope
Time frame: Up to 24 hours
Percentage of success of endotracheal tube insertion
Time frame: Up to 24 hours
Removal of the bronchoscope
Time frame: Up to 24 hours
Complications
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Badawi, M.D principal investigator
Cairo University
Maha M Ismail Youssef, M.D principal investigator
Cairo University
Sara Farouk Habib, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovassapian Fibreoptic Intubating Airway in people with Ovassapian VS Fekry Airways, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of intubation (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.