Fekry VS the Air-Q Intubating AirwaysNCT04450121
Comparison Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients
A study testing Patients will be intubated using Air-Q airway in people with Fekry VS the Air-Q Intubating 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fekry VS the Air-Q Intubating Airways
- What is being tested?
- Patients will be intubated using Air-Q airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2019to 3 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years old.
- Of both sexes.
- With American Society of Anaesthesiologists (ASA) physical status class I-ll.
- Scheduled for elective surgery under general anesthesia requiring ETT placement.
Who cannot join
- Patient refusal.
- Patient that has any documented or suspected difficult airway or neck or upper respiratory tract abnormalities, facial deformities that invalidate Ganzouri airway score.
- Patient that has any active cardiac or chest problem and risk of aspiration.
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 the Air-Q Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) and Fekry Oral Intubating Airway (Ameco Technology, Cairo, Egypt).
Read the detailed description
The Air-Q Intubating Laryngeal Airway (Air-Q):
The Air-Q™ Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) is a SAD that was designed primarily to act as a conduit for the passage of a cuffed tracheal tube during tracheal intubation (1), Compared with the LMA, the Air-Q has a shorter silicon airway tube that allows an easy visualization of vocal cords and intubation and removal of the device after tracheal tube insertion. The device has a removable color coded connector, allows intubation through the airway tube. The device is also wider, C-curved and has an integrated bite block which makes it easier to place reinforces the tube and diminishes the need for a separate bite block, with an elevation ramp that facilitates intubation and directs the tube toward the laryngeal inlet. It also has a built-up mask for improved seal. All of these features facilitate the passage of the tracheal tube through the device and into the trachea.
Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):
Several modifications of oropharyngeal airways aiming to allow facilitation of intubation and easy removal of the airway after placement of ETT.
In Fekry airway, modification of the Williams airway facilitates the airway removal after ETT insertion without need to remove the international part of the ETT (this reduce risk of ETT dislodgement during airway removal).
The modification made to the Williams airway is that the roof of the proximal cylindrical tunnel is opened from its upper part to allow one step insertion of the tube. There is no need for removal of the tube connector after tube insertion. It allows passage of the suction catheter and may allow oxygen insufflations through a catheter.
As mastering airway management in difficult cases is an essential job to anesthesiologist, we think it is important to find an easy adjunct to this hard job.
investigators hypothesized that Fekry airway could offer a better conduit to flexible fiberoptic intubation rather than the air-Q device, because it needs less experience in how to use, less intubation time.
- Conditions
- Fekry VS the Air-Q Intubating Airways
- Being tested
- Patients will be intubated using Air-Q airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be intubated using Air-Q airwayDevice
Both groups:
Grade 1: Split airway provides an unobstructed path for bronchoscope from mouth to glottis.
Grade 2: Tongue rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
Grade 3: Epiglottis rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
Grade 4: Tongue and epiglottis rest against posterior pharyngeal wall, both causing partial obstruction to bronchoscope.
Grade 5: Tongue rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure).
Grade 6: Epiglottis rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure)
| Study group | Role | What they receive |
|---|---|---|
| GA (n =22) | Active comparator | Patients will be intubated using Air-Q airway Receives: Device: Patients will be intubated using Air-Q airway |
| GF (n =22) | Active comparator | Patients will be intubated using Fekry airway Receives: Device: Patients will be intubated using Air-Q airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy insertion time
Time from introducing the tip of scope through the proximal end of the airway device or mouth until the visualization of carina (multiple attempts will be added to compute this time
Measured: Withen 15 seconds from induction og Generel Anesthesia
Secondary outcomes (6)
ITHIN Intubation time
Timing of complete intubation
Measured: Withen 15 seconds from induction og Generel Anesthesia
Grade of endoscopic view
Endoscopic view grading
Measured: Withen 15 seconds from induction og Generel Anesthesia
Success rate of intubation from 1st trial
1st trial Success
Measured: Withen 15 seconds from induction og Generel Anesthesia
Score of success of endotracheal intubation
Endotracheal intubation Score of success
Measured: Withen 15 seconds from induction og Generel Anesthesia till Study Completion
Number of intubation and device insertion attempts
Attempts Number of intubation and device insertion
Measured: Withen 15 seconds from induction og Generel Anesthesia
Complications
Coughing, laryngospasm, stridor, hoarseness, bronchospasm, arterial desaturation (SpO2<92), aspiration, bleeding or swelling to the lips, tongue, teeth, or blood staining the airway.
Measured: Withen 15 seconds from induction og Generel Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start9 Jan 2019
- Primary completion15 Sep 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fekry VS the Air-Q Intubating 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
- Comparison between the two airways regarding: 1. Time to Glottic view. 2. Grade of bronchoscopic view. 3. Success of intubation from 1st trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 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 UniversityAhmed Moamen Mahmoud, M.Sc, Principal investigator, Cairo UniversityHany M El-Hadi Shoukat, M.D, Principal investigator, Cairo UniversityAhmed Abdalla Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450121
- Sponsor's protocol ID
- N 54-2018/Ms
- Status last verified
- Jun 2020
- First submitted
- 13 Jan 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Publication
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 Between Fekry and Air-Q Intubating Airways as Conduit for Fibreoptic Endotracheal Intubation in Adult Patients
- ClinicalTrials.gov ID
- NCT04450121
- Acronym / sponsor ID
- N 54-2018/Ms
- Conditions
- Fekry VS the Air-Q Intubating Airways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 29 Jun 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 the Air-Q Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) and Fekry Oral Intubating Airway (Ameco Technology, Cairo, Egypt).
Detailed description
The Air-Q Intubating Laryngeal Airway (Air-Q):
The Air-Q™ Intubating Laryngeal Airway (Air-Q) (Cookgas, St. Louis, MO, USA) is a SAD that was designed primarily to act as a conduit for the passage of a cuffed tracheal tube during tracheal intubation (1), Compared with the LMA, the Air-Q has a shorter silicon airway tube that allows an easy visualization of vocal cords and intubation and removal of the device after tracheal tube insertion. The device has a removable color coded connector, allows intubation through the airway tube. The device is also wider, C-curved and has an integrated bite block which makes it easier to place reinforces the tube and diminishes the need for a separate bite block, with an elevation ramp that facilitates intubation and directs the tube toward the laryngeal inlet. It also has a built-up mask for improved seal. All of these features facilitate the passage of the tracheal tube through the device and into the trachea.
Fekry airway (Oral Intubating Airway; Egyptian Patent 28118):
Several modifications of oropharyngeal airways aiming to allow facilitation of intubation and easy removal of the airway after placement of ETT.
In Fekry airway, modification of the Williams airway facilitates the airway removal after ETT insertion without need to remove the international part of the ETT (this reduce risk of ETT dislodgement during airway removal).
The modification made to the Williams airway is that the roof of the proximal cylindrical tunnel is opened from its upper part to allow one step insertion of the tube. There is no need for removal of the tube connector after tube insertion. It allows passage of the suction catheter and may allow oxygen insufflations through a catheter.
As mastering airway management in difficult cases is an essential job to anesthesiologist, we think it is important to find an easy adjunct to this hard job.
investigators hypothesized that Fekry airway could offer a better conduit to flexible fiberoptic intubation rather than the air-Q device, because it needs less experience in how to use, less intubation time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Comparison between the two airways regarding: 1. Time to Glottic view. 2. Grade of bronchoscopic view. 3. Success of intubation from 1st trial.
| Arm | Type | Receives |
|---|---|---|
| GA (n =22) | Active comparator | Device: Patients will be intubated using Air-Q airwayPatients will be intubated using Air-Q airway |
| GF (n =22) | Active comparator | Device: Patients will be intubated using Air-Q airwayPatients will be intubated using Fekry airway |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years old.
- Of both sexes.
- With American Society of Anaesthesiologists (ASA) physical status class I-ll.
- Scheduled for elective surgery under general anesthesia requiring ETT placement.
Key exclusion criteria (3 listed)
- Patient refusal.
- Patient that has any documented or suspected difficult airway or neck or upper respiratory tract abnormalities, facial deformities that invalidate Ganzouri airway score.
- Patient that has any active cardiac or chest problem and risk of aspiration.
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 |
|---|---|---|
| Patients will be intubated using Air-Q airwayBoth groups: Grade 1: Split airway provides an unobstructed path for bronchoscope from mouth to glottis. Grade 2: Tongue rests against posterior pharyngeal wall causing partial obstruction to bronchoscope. Grade 3: Epiglottis rests against posterior pharyngeal wall causing partial obstruction to bronchoscope. Grade 4: Tongue and epiglottis rest against posterior pharyngeal wall, both causing partial obstruction to bronchoscope. Grade 5: Tongue rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure). Grade 6: Epiglottis rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure) | Device | GA (n =22), GF (n =22) |
Primary outcome
Endoscopy insertion time
Time frame: Withen 15 seconds from induction og Generel Anesthesia
Time from introducing the tip of scope through the proximal end of the airway device or mouth until the visualization of carina (multiple attempts will be added to compute this time
6 secondary outcomes
ITHIN Intubation time
Time frame: Withen 15 seconds from induction og Generel Anesthesia
Grade of endoscopic view
Time frame: Withen 15 seconds from induction og Generel Anesthesia
Success rate of intubation from 1st trial
Time frame: Withen 15 seconds from induction og Generel Anesthesia
Score of success of endotracheal intubation
Time frame: Withen 15 seconds from induction og Generel Anesthesia till Study Completion
Number of intubation and device insertion attempts
Time frame: Withen 15 seconds from induction og Generel Anesthesia
Complications
Time frame: Withen 15 seconds from induction og Generel Anesthesia
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.
- Individual participant dataSharing planned: Undecided. Till Publication
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
Ahmed Moamen Mahmoud, M.Sc 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 Patients will be intubated using Air-Q airway in people with Fekry VS the Air-Q Intubating 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 4 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?
Endoscopy insertion time (time frame: Withen 15 seconds from induction og Generel Anesthesia). 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; AzTrials last refreshed its copy on 7 Nov 2026.