Laryngeal Masks ComparisonNCT06140667
Laryseal Pro LMA Versus Ambu Aura Gain LMA in Elective Ophthalmological Surgeries
A study testing LarysealTM Pro and Ambu Aura Gain in people with Laryngeal Masks Comparison, run by Cairo University at 1 site 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
- Laryngeal Masks Comparison
- What is being tested?
- LarysealTM Pro and Ambu Aura Gain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2023to 17 Jul 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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
- Active upper respiratory tract infections, pneumonia, COPD \& exacerbated bronchial asthma.
- 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.
- Patients with any cardiac conditions (IHD, RHD, decompensated heart failure and arrhythmia).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
About this study
Official title: Comparative Evaluation of the Laryseal TM Pro Laryngeal Mask Airway With Ambu Aura Gain Laryngeal Mask Airway in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmological Surgeries. A Randomized Controlled Study
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. Many health care providers do not have the requisite knowledge and enough practice to perform safe and quick intubation. For these providers, SADs can be a valid alterative especially in untrained personnel, or when tracheal intubation is impossibe.
Both devices are with a cuff modified to improve the seal around the glottis and a drainage tube to provide a bypass channel for regurgitated gastric contents, prevent gastric insufflation, and allow the passage of a gastric tube. These features are designed to improve the safety of the mask and broaden its scope, especially when used with positive pressure ventilation.
Read more
The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) that can accept tracheal tube in sizes ranging from 6.5 up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr.
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. The Laryseal pro could provide a 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 if needed with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. All these features of laryseal pro allow quick easy first time insertion success.
After approval of the Local Ethical Committee and obtaining an informed written consent from every patient, then patients will be categorized randomly into two equal groups using the computer allocation software to be put into opaque closed-envelopes: GL (n=27): Laryseal TM Pro. GA (n=27): Ambu Aura Gain.
- Conditions
- Laryngeal Masks Comparison
- Being tested
- LarysealTM Pro, Ambu Aura Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ambu Aura GainDevice
The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) with maximum suction catheter size of 16 Fr.
| Study group | Role | What they receive |
|---|---|---|
| LarysealTM Pro | Other | Not described Receives: Device: Ambu Aura Gain |
| Ambu Aura Gain | Other | Not described Receives: Device: LarysealTM Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure (OLP) (cmH2O)
It is defined as the pressure at which leak starts. It will be calculated by the following steps : the adjustable pressure limit valve of the circle system is set at 60 cmH2O (airway pressures not allowed to exceed 40 cmH2O), the fixed fresh gas flow is set at 3 l.min-1, then the airway pressure is measured on the breathing system pressure gauge, so that leak pressure is considered as the achieved plateau airway pressure while the patient is apneic. At this stage an audible leak at the mouth (sound of gas escaping from mouth heard by listening close to patient's mouth) and stomach (sound of gas escaping into esophagus heard by auscultation over epigastrium) will be ascertained. To ensure safety, maximal allowable OLP will be fixed at 40 cmH2O
Measured: It will be measured at 5,15,30,45 and 60 minutes after successful SAD placement and effective ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start17 Nov 2023
- Primary completion17 May 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Masks ComparisonStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
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
- NCT06140667
- Sponsor's protocol ID
- MK-2023
- Status last verified
- Sep 2024
- First submitted
- 31 Oct 2023
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Laryseal TM Pro Laryngeal Mask Airway With Ambu Aura Gain Laryngeal Mask Airway in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmological Surgeries. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06140667
- Acronym / sponsor ID
- MK-2023
- Conditions
- Laryngeal Masks Comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 20 Nov 2023 (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. Many health care providers do not have the requisite knowledge and enough practice to perform safe and quick intubation. For these providers, SADs can be a valid alterative especially in untrained personnel, or when tracheal intubation is impossibe.
Both devices are with a cuff modified to improve the seal around the glottis and a drainage tube to provide a bypass channel for regurgitated gastric contents, prevent gastric insufflation, and allow the passage of a gastric tube. These features are designed to improve the safety of the mask and broaden its scope, especially when used with positive pressure ventilation.
The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) that can accept tracheal tube in sizes ranging from 6.5 up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr.
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. The Laryseal pro could provide a 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 if needed with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. All these features of laryseal pro allow quick easy first time insertion success.
After approval of the Local Ethical Committee and obtaining an informed written consent from every patient, then patients will be categorized randomly into two equal groups using the computer allocation software to be put into opaque closed-envelopes: GL (n=27): Laryseal TM Pro. GA (n=27): Ambu Aura Gain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LarysealTM Pro | Other | Device: Ambu Aura Gain |
| Ambu Aura Gain | Other | Device: LarysealTM Pro |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-55 years old
- ASA I\& II
- Both sexes
- El-Ganzouri Airway Score < or =2
Key exclusion criteria (6 listed)
- Active upper respiratory tract infections, pneumonia, COPD \& exacerbated bronchial asthma.
- 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 |
|---|---|---|
| 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. | Device | Ambu Aura Gain |
| Ambu Aura GainThe AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) with maximum suction catheter size of 16 Fr. | Device | LarysealTM Pro |
Primary outcome
Oropharyngeal leak pressure (OLP) (cmH2O)
Time frame: It will be measured at 5,15,30,45 and 60 minutes after successful SAD placement and effective ventilation.
It is defined as the pressure at which leak starts. It will be calculated by the following steps : the adjustable pressure limit valve of the circle system is set at 60 cmH2O (airway pressures not allowed to exceed 40 cmH2O), the fixed fresh gas flow is set at 3 l.min-1, then the airway pressure is measured on the breathing system pressure gauge, so that leak pressure is considered as the achieved plateau airway pressure while the patient is apneic. At this stage an audible leak at the mouth (sound of gas escaping from mouth heard by listening close to patient's mouth) and stomach (sound of gas escaping into esophagus heard by auscultation over epigastrium) will be ascertained. To ensure safety, maximal allowable OLP will be fixed at 40 cmH2O
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 26 Sep 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LarysealTM Pro and Ambu Aura Gain in people with Laryngeal Masks Comparison, 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 6 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 26 Sep 2024. 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?
Oropharyngeal leak pressure (OLP) (cmH2O) (time frame: It will be measured at 5,15,30,45 and 60 minutes after successful SAD placement and effective ventilation.). 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 26 Sep 2024.