Difficult IntubationNCT05607433
Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation
A study testing cook ®Airway Exchanger Catheter in people with Difficult Intubation, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- cook ®Airway Exchanger Catheter
- 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
- Nov 2022to Dec 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age : 18 to 60
- ASA physical status 1 and 2
- body weight less than 90 kilos
- Ganzouri airway score less than or equal to 3.
Who cannot join
- Active respiratory or cardiac disease
- Any expected airway difficulties
- Craniofacial abnormalities or fractures
- patients with abnormal coagulation profile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.
The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.
Read the detailed description
Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .
the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.
- Conditions
- Difficult Intubation
- Being tested
- cook ®Airway Exchanger Catheter
- Keywords
- assisted intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cook ®Airway Exchanger CatheterDevice
A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.
| Study group | Role | What they receive |
|---|---|---|
| Air Q ILA group | Experimental | Air Q supraglottic device will be placed in the participants in this group . Receives: Device: cook ®Airway Exchanger Catheter |
| Ambu AuraGain group | Experimental | Ambu AuraGain supraglottic device will be placed in the participants in this group . Receives: Device: cook ®Airway Exchanger Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total endotracheal intubation time
tube exchanger intubation time plus endotracheal intubation time
Measured: time of tube exchanger insertion and endotracheal tube insertion
Secondary outcomes (2)
success rate of endotracheal intubation
incidence of successful endotracheal intubation
Measured: 1 second after insertion tube exchanger until successful endotracheal intubation
Tube exchanger insertion time
time from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
Measured: from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized comparative study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Zakaria Saleh Hassan Alrify, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607433
- Sponsor's protocol ID
- supraglottic devices
- Status last verified
- Nov 2022
- First submitted
- 13 Sep 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
PubMed 21320087Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. doi: 10.1177/0310057X1003800217.
PubMed 20369770
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT05607433
- Acronym / sponsor ID
- supraglottic devices
- Conditions
- Difficult Intubation
- Keywords
- assisted intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Nov 2022 (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 study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.
Detailed description
Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .
the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Air Q ILA group | Experimental | Device: cook ®Airway Exchanger CatheterAir Q supraglottic device will be placed in the participants in this group . |
| Ambu AuraGain group | Experimental | Device: cook ®Airway Exchanger CatheterAmbu AuraGain supraglottic device will be placed in the participants in this group . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age : 18 to 60
- ASA physical status 1 and 2
- body weight less than 90 kilos
- Ganzouri airway score less than or equal to 3.
Key exclusion criteria (4 listed)
- Active respiratory or cardiac disease
- Any expected airway difficulties
- Craniofacial abnormalities or fractures
- patients with abnormal coagulation profile
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 |
|---|---|---|
| cook ®Airway Exchanger CatheterA tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device. | Device | Air Q ILA group, Ambu AuraGain group |
Primary outcome
Total endotracheal intubation time
Time frame: time of tube exchanger insertion and endotracheal tube insertion
tube exchanger intubation time plus endotracheal intubation time
2 secondary outcomes
success rate of endotracheal intubation
Time frame: 1 second after insertion tube exchanger until successful endotracheal intubation
Tube exchanger insertion time
Time frame: from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 21320087Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
- Background: PubMed 20369770Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. doi: 10.1177/0310057X1003800217.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cook ®Airway Exchanger Catheter in people with Difficult Intubation, 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 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoda Alrify (002 01004226722, hodazakariasaleh@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total endotracheal intubation time (time frame: time of tube exchanger insertion and endotracheal tube insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05607433, which also lists 2 linked publications.
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 7 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.