Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal IntubationNCT06945029
A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population
A study testing Ambu Aura Gain and Laryseal Pro in people with Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation
- What is being tested?
- Ambu Aura Gain and Laryseal Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age starting from 4 years to 8 years.
- Both genders.
- ASA physical status class I-ll.
- Apparently anatomically normal with normal percentile growth chart, not suspected to have difficult airway.
- Scheduled for day case surgeries more than one hour under general anesthesia.
Who cannot join
- Parents refusal.
- Abnormality in head and neck or craniofacial anomalies as Piere Robbin syndrome, facial trauma, head and neck tumours, swellings and hemangiomas.
- Patients at risk of regurgitation and pulmonary aspiration such as patients with hiatus hernia, GERD or DM.
- Abnormal or contraindicated cervical spine flexion/extension/rotation.
- Allergy to any EAD components.
- Any active respiratory or cardiac disease and metabolic disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, Giza Governorate, 1111
Omnia Y Kamel, Doctorate degree, 01270130326, omniayehiakamel90@gmail.com
About this study
Official title: A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population: A Prospective Randomized Controlled Study
This study aims to compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.
Read the detailed description
Airway management is a skill that must be mastered by all anesthesiologists. Since the introduction of the extraglottic airway devices (EADs) in the early 1980s, the EAD has become a central element in the management of airway in adults and children. Some of the EADs are specially designed to allow endotracheal intubation whether blindly or with the use of fiberoptic bronchoscope (FOB). So, with the use of EAD, it is possible to provide adequate oxygenation and at the same time perform fibreoptic bronchoscopy-guided trans-device intubation, providing less hemodynamic stress response and less postoperative complications. As patient's safety always comes first, the use of flexible bronchoscopes became more widespread, strong literature favored visualization of the glottis over blind intubation. So, the use of the intubating EADs as aconduit for fiberoptic intubation is favoured over blind intubation. In addition, FOB guided intubation through EAD is a central step in the algorithm of the expected as well as the unexpected difficult airway in children.
The Ambu Aura Gain is a second-generation EAD which was presented in the clinical field in 2018. It is characterized by a wide inner diameter tunnel which has a C shaped curve with an angle guiding the endotracheal tube (ETT) into the laryngeal inlet. The presence of gastric access through a second port helps to vent the stomach and for gastric suctioning. In a previous study The Ambu Aura Gain has been shown to be an effective conduit for FOB guided intubation regarding feasibility of FOB-guided intubation, oropharyngeal leak pressure, gastric leak pressure and fibreoptic view in small children.
Laryseal Pro is a novel device and a new generation of EADs that was developed in 2018. It is believed to be a method for rapid, secure airway management which improves patient safety with gastric access. It has a catheter channel for efficient removal of fluids and gastric content, reducing risk of aspiration and integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. Besides, it elevates the epiglottis for easy trauma-free ETT or bronchoscope insertion. In spite of that, it's clinical performance and efficacy as a conduit for fiberoptic tracheal intubation in pediatric population hasn't been studied by any study in literature till the present time.
To our knowledge, this is the first study to evaluate the clinical efficacy of laryseal Pro EGA in pediatric population. In this study we will compare between two extra glottic devices, Laryseal Pro and Ambu Aura Gain regarding clinical performance and efficacy with respect to the time of endotracheal intubation through fibreoptic, laryngeal view grade, airway seal pressure, success rate of intubation, number of attempts of intubation, number of attempts of SGA insertion and complications in pediatric population.
- Being tested
- Ambu Aura Gain, Laryseal Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu Aura GainDevice
compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.
Laryseal ProDevice
compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric
| Study group | Role | What they receive |
|---|---|---|
| Ambu Aura Gain extraglottic device group | Active comparator | In this group, Ambu Aura Gain extraglottic device will be used as a conduit for fiberoptic endotracheal intubation. Receives: Device: Ambu Aura Gain |
| Laryseal pro extraglottic device groupI | Active comparator | In this group, Laryseal pro extraglottic device will be used as a conduit for fiberoptic endotracheal intubation. Receives: Device: Laryseal Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
The FOB-guided intubation time using the EAD in seconds
the time elapsing between circuit disconnection from the EAD for the purpose of bronchoscope-guided intubation till reconnecting the circuits to the ETT and appearance of capnography waves.
Measured: First 10 seconds of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start15 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective Randomized Controlled Study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Yahia El Sayed Kamel, Cairo University
- Investigators
- Jehan A El-kholy, Professor, Study chair, Cairo UniversityMaha M.I Youssef, Assistant Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945029
- Sponsor's protocol ID
- MD-38-2025
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06945029
- Acronym / sponsor ID
- MD-38-2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 25 Apr 2025 (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.
This study aims to compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.
Detailed description
Airway management is a skill that must be mastered by all anesthesiologists. Since the introduction of the extraglottic airway devices (EADs) in the early 1980s, the EAD has become a central element in the management of airway in adults and children. Some of the EADs are specially designed to allow endotracheal intubation whether blindly or with the use of fiberoptic bronchoscope (FOB). So, with the use of EAD, it is possible to provide adequate oxygenation and at the same time perform fibreoptic bronchoscopy-guided trans-device intubation, providing less hemodynamic stress response and less postoperative complications. As patient's safety always comes first, the use of flexible bronchoscopes became more widespread, strong literature favored visualization of the glottis over blind intubation. So, the use of the intubating EADs as aconduit for fiberoptic intubation is favoured over blind intubation. In addition, FOB guided intubation through EAD is a central step in the algorithm of the expected as well as the unexpected difficult airway in children.
The Ambu Aura Gain is a second-generation EAD which was presented in the clinical field in 2018. It is characterized by a wide inner diameter tunnel which has a C shaped curve with an angle guiding the endotracheal tube (ETT) into the laryngeal inlet. The presence of gastric access through a second port helps to vent the stomach and for gastric suctioning. In a previous study The Ambu Aura Gain has been shown to be an effective conduit for FOB guided intubation regarding feasibility of FOB-guided intubation, oropharyngeal leak pressure, gastric leak pressure and fibreoptic view in small children.
Laryseal Pro is a novel device and a new generation of EADs that was developed in 2018. It is believed to be a method for rapid, secure airway management which improves patient safety with gastric access. It has a catheter channel for efficient removal of fluids and gastric content, reducing risk of aspiration and integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. Besides, it elevates the epiglottis for easy trauma-free ETT or bronchoscope insertion. In spite of that, it's clinical performance and efficacy as a conduit for fiberoptic tracheal intubation in pediatric population hasn't been studied by any study in literature till the present time.
To our knowledge, this is the first study to evaluate the clinical efficacy of laryseal Pro EGA in pediatric population. In this study we will compare between two extra glottic devices, Laryseal Pro and Ambu Aura Gain regarding clinical performance and efficacy with respect to the time of endotracheal intubation through fibreoptic, laryngeal view grade, airway seal pressure, success rate of intubation, number of attempts of intubation, number of attempts of SGA insertion and complications in pediatric population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective Randomized Controlled Study.
| Arm | Type | Receives |
|---|---|---|
| Ambu Aura Gain extraglottic device group | Active comparator | Device: Ambu Aura GainIn this group, Ambu Aura Gain extraglottic device will be used as a conduit for fiberoptic endotracheal intubation. |
| Laryseal pro extraglottic device groupI | Active comparator | Device: Laryseal ProIn this group, Laryseal pro extraglottic device will be used as a conduit for fiberoptic endotracheal intubation. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age starting from 4 years to 8 years.
- Both genders.
- ASA physical status class I-ll.
- Apparently anatomically normal with normal percentile growth chart, not suspected to have difficult airway.
- Scheduled for day case surgeries more than one hour under general anesthesia.
Key exclusion criteria (6 listed)
- Parents refusal.
- Abnormality in head and neck or craniofacial anomalies as Piere Robbin syndrome, facial trauma, head and neck tumours, swellings and hemangiomas.
- Patients at risk of regurgitation and pulmonary aspiration such as patients with hiatus hernia, GERD or DM.
- Abnormal or contraindicated cervical spine flexion/extension/rotation.
- Allergy to any EAD components.
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 |
|---|---|---|
| Ambu Aura Gaincompare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population. | Device | Ambu Aura Gain extraglottic device group |
| Laryseal Procompare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric | Device | Laryseal pro extraglottic device groupI |
Primary outcome
The FOB-guided intubation time using the EAD in seconds
Time frame: First 10 seconds of intubation
the time elapsing between circuit disconnection from the EAD for the purpose of bronchoscope-guided intubation till reconnecting the circuits to the ETT and appearance of capnography waves.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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.
Jehan A El-kholy, Professor study chair
Cairo University
Maha M.I Youssef, Assistant Professor study director
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 Ambu Aura Gain and Laryseal Pro in people with Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal 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 5 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Y Kamel, Doctorate degree (01270130326, omniayehiakamel90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The FOB-guided intubation time using the EAD in seconds (time frame: First 10 seconds of intubation). 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 25 Apr 2025.