Respiration and the Airways With Laryngeal MasksNCT05624073
Blind Tracheal Intubation Through Supraglottic Airway Devices
An observational study of Respiration and the Airways With Laryngeal Masks, run by Cairo University at 2 sites in Egypt.
Trial summary
Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiration and the Airways With Laryngeal Masks
- What is being tested?
- Air-QTM Blocker and LarySealTM Pro
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Dec 2022to 1 Dec 2023
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Eligible subjects of both sexes will be consecutively enrolled and randomly allocated to LarysealTM Pro group or Air-QTM Blocker group through an online randomization program (http://www.randomizer.org) with an allocation ratio of 1:1. GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation. GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.
Who may be able to join
- Age: 18-55 years old.
- ASA I\&II.
- Both sexes.
- El-Ganzouri Airway Score < or =2
Who cannot join
- History of upper respiratory tract infections.
- History of obstructive sleep apnea (OSA) or STOP Bang-Score > 4.
- Potentially full stomach (trauma, morbid obesity BMI> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
- Esophageal reflux (hiatus hernia).
- Coagulation disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
Reham Ali Abdelhaleem Abdelrahman, MD, 00201009136408, rehamali72@hotmail.com
- Recruiting
Reham Ali Abdelhaleem Abdelrahman
Cairo, 11562
Reham Ali Abdelhaleem Abdelrahman, M.D., 00201009136408, rehamali72@hotmail.com
About this study
Official title: Comparison of Blind Tracheal Intubation Through the Air-QTM Blocker and the LarySealTM Pro Laryngeal Mask Airways in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmic Operations
Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation \&ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.
Read the detailed description
The laryseal pro could provide rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance, and elevates the epiglottis for easy, trauma-free ETT tube or bronchoscope insertion. According to the manufacturer: all these features of laryseal pro allow quick easy first time insertion success. As, the laryseal pro is being of shorter breathing tube and smaller cuff in comparison to Air-Q Blocker, so the laryseal pro is expecting to be more amazing than the Air-Q Blocker especially for the new trainers regarding the total insertion time of the endotracheal tube and success rate. Jatin et al. 2021reported that Air-Q Intubating Laryngeal Airway resulted in significantly more success rate and ease of intubation as compared to Ambu Aura Gain. Andrzej et al. 2018 stated that success rate of blind intubation through Air-Q was 75% when compared to 80% in I-gel group. In contrary, there are limited studies available in literature on blind tracheal intubation through the laryseal pro.
- Being tested
- Air-QTM Blocker, LarySealTM Pro
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-QTM BlockerDevice
The Air-QTM Blocker (Cookgas LLC, Mercury Medical, Clearwater, FL, USA) is a SAD that is intended for use as a primary airway seal and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. Its design includes a large airway tube inner diameter, a short airway tube length, and a tethered, removable standard 15mm circuit adapter. These features enable direct insertion of larger tracheal tubes up to 7.5 and 8.5mm inner diameters for Air-Q sizes 3.5 and 4.5 respectively (according to body weight; size 3.5: 50-70Kg, size 4.5:70-100Kg). In addition to the soft blocker channel (guide tube) that acts as a conduit for placing medical devices such as NG (Nasogastric) or Blocker tubes. NG tubes are used to decompress and suction the stomach. Standard NG tubes up to 18 Fr. are suitable for all Air-Q Blocker sizes
LarySealTM ProDevice
The LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in: sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. Both devices accommodated standard conventional endotracheal tubes for intubation.
| Study group | Role | What they receive |
|---|---|---|
| Air-QTM Blocker | GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation. Receives: Device: LarySealTM Pro | |
| LarySealTM Pro Laryngeal Mask | GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation. Receives: Device: Air-QTM Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total insertion time (seconds)
Total insertion time (seconds): insertion time (seconds) of the SAD is the time needed for correct SAD placement \&started when SAD touched teeth to the first recorded rectangular capnogram curve with satisfactory bilateral chest expansion + insertion time of the endotracheal tube through the SAD (seconds) is the time in seconds from insertion of the endotracheal tube blindly until capnographic confirmation.
Measured: 200 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start17 Dec 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration and the Airways With Laryngeal MasksStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
- Investigators
- Reham Ali Abdelhaleem Abdelrahman, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624073
- Sponsor's protocol ID
- EH-2022
- Status last verified
- Feb 2023
- First submitted
- 13 Nov 2022
- Last updated
- 14 Feb 2023
- 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 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blind Tracheal Intubation Through the Air-QTM Blocker and the LarySealTM Pro Laryngeal Mask Airways in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmic Operations
- ClinicalTrials.gov ID
- NCT05624073
- Acronym / sponsor ID
- EH-2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 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.
Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation \&ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.
Detailed description
The laryseal pro could provide rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance, and elevates the epiglottis for easy, trauma-free ETT tube or bronchoscope insertion. According to the manufacturer: all these features of laryseal pro allow quick easy first time insertion success. As, the laryseal pro is being of shorter breathing tube and smaller cuff in comparison to Air-Q Blocker, so the laryseal pro is expecting to be more amazing than the Air-Q Blocker especially for the new trainers regarding the total insertion time of the endotracheal tube and success rate. Jatin et al. 2021reported that Air-Q Intubating Laryngeal Airway resulted in significantly more success rate and ease of intubation as compared to Ambu Aura Gain. Andrzej et al. 2018 stated that success rate of blind intubation through Air-Q was 75% when compared to 80% in I-gel group. In contrary, there are limited studies available in literature on blind tracheal intubation through the laryseal pro.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air-QTM Blocker | – | Device: LarySealTM ProGA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation. |
| LarySealTM Pro Laryngeal Mask | – | Device: Air-QTM BlockerGL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eligible subjects of both sexes will be consecutively enrolled and randomly allocated to LarysealTM Pro group or Air-QTM Blocker group through an online randomization program (http://www.randomizer.org) with an allocation ratio of 1:1. GL (n=35): Laryseal TM Pro will be used as a conduit for blind endotracheal intubation. GA (n=35): Air-Q Blocker TM will be used as a conduit for blind endotracheal intubation.
Key inclusion criteria (4 listed)
- Age: 18-55 years old.
- ASA I\&II.
- Both sexes.
- El-Ganzouri Airway Score < or =2
Key exclusion criteria (5 listed)
- History of upper respiratory tract infections.
- History of obstructive sleep apnea (OSA) or STOP Bang-Score > 4.
- Potentially full stomach (trauma, morbid obesity BMI> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
- Esophageal reflux (hiatus hernia).
- Coagulation disorders.
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 |
|---|---|---|
| Air-QTM BlockerThe Air-QTM Blocker (Cookgas LLC, Mercury Medical, Clearwater, FL, USA) is a SAD that is intended for use as a primary airway seal and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. Its design includes a large airway tube inner diameter, a short airway tube length, and a tethered, removable standard 15mm circuit adapter. These features enable direct insertion of larger tracheal tubes up to 7.5 and 8.5mm inner diameters for Air-Q sizes 3.5 and 4.5 respectively (according to body weight; size 3.5: 50-70Kg, size 4.5:70-100Kg). In addition to the soft blocker channel (guide tube) that acts as a conduit for placing medical devices such as NG (Nasogastric) or Blocker tubes. NG tubes are used to decompress and suction the stomach. Standard NG tubes up to 18 Fr. are suitable for all Air-Q Blocker sizes | Device | LarySealTM Pro Laryngeal Mask |
| LarySealTM ProThe LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in: sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. Both devices accommodated standard conventional endotracheal tubes for intubation. | Device | Air-QTM Blocker |
Primary outcome
Total insertion time (seconds)
Time frame: 200 seconds
Total insertion time (seconds): insertion time (seconds) of the SAD is the time needed for correct SAD placement \&started when SAD touched teeth to the first recorded rectangular capnogram curve with satisfactory bilateral chest expansion + insertion time of the endotracheal tube through the SAD (seconds) is the time in seconds from insertion of the endotracheal tube blindly until capnographic confirmation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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.
Reham Ali Abdelhaleem Abdelrahman, M.D. principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration and the Airways With Laryngeal Masks, run by Cairo University at 2 sites 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 5 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Reham Ali Abdelhaleem Abdelrahman, M.D. (00201009136408, rehamali72@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total insertion time (seconds) (time frame: 200 seconds). 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 14 Feb 2023.