Airway ControlNCT07274280
Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation
A study testing supraglottic airway device in people with Airway Control, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This study aims to compare the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Airway Control
- What is being tested?
- supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 15 Jul 2026
- 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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Age 2-9 years.
- Weight 10-30 kg.
- ASA Physical Status I or II.
- Elective day-case surgery requiring general anesthesia with controlled ventilation using an SGAD.
- Written informed consent from parent(s) or legal guardian(s).
Who cannot join
- • ASA Physical Status III or IV.
- Known or predicted difficult airway.
- History of significant respiratory disease (e.g., asthma requiring frequent medication, active upper respiratory tract infection, reactive airway disease within the past month).
- History of significant gastroesophageal reflux, hiatal hernia, BMI ≥ 35, or other conditions predisposing to increased aspiration risk.
- Neuromuscular disorders affecting airway patency or respiratory function.
- Known allergy or contraindication to study devices or anesthetic medications.
- Participation in other clinical trials that could influence study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Ambu AuraGain, LarySeal Pro LMA and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation: A Randomized Comparative Trial
This study aims to compare the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients aged 2-9 years, weighing 10-30 kg, American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for elective day-case surgery suitable for supraglottic airway device (SGAD) use.Patients will be randomly assigned (n= 55 per group) using a computer-generated random number sequence (www.random.org) to one of three groups:
- Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China)
- Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s):
- Oropharyngeal Leak Pressure (OLP).
- Demographic and Clinical Data.
- Hemodynamics.
- Insertion Data.
- Peak Airway Pressure (Ppeak).
- Fiberoptic Glottic View Assessment.
- Ultrasound Assessment of Gastric Insufflation.
- Perioperative Complications.bronchospasm, or sore throat.
- Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).
- Conditions
- Airway Control
- Being tested
- supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic airway deviceDevice
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| Group I: Ambu AuraGain LMA | Active comparator | supraglottic Airway device used for airway control Receives: Device: supraglottic airway device |
| Group II: LarySeal Pro LMA | Active comparator | supraglottic airway device used for airway control Receives: Device: supraglottic airway device |
| Group III: I-gel | Active comparator | supraglottic airway device used for airway control Receives: Device: supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Leak Pressure (OLP)
Measured: from enrollment to the end of the study at 6 months
Secondary outcomes (3)
Peak Airway Pressure (P peak)
Measured: From enrollement to the end of the study at 6 months
Fiberoptic glottic airway view
Measured: From enrollment to the end of the study at 6 months
Ultrasound Assessment of Gastric Insufflation
Measured: From enrollement to the end of the study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ControlStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Mohamed Ahmed Abdelhafez, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274280
- Sponsor's protocol ID
- N-288-2025
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic and clinical data Insertion data of the SGAD (time, successfulness) OLP Ppeak Hemodynamic data Fiberoptic glottic view data Ultrasound assessment of gastric insufflation data Perioperative complication data
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Ambu AuraGain, LarySeal Pro LMA and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation: A Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT07274280
- Acronym / sponsor ID
- N-288-2025
- Conditions
- Airway Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 10 Dec 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 the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients aged 2-9 years, weighing 10-30 kg, American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for elective day-case surgery suitable for supraglottic airway device (SGAD) use.Patients will be randomly assigned (n= 55 per group) using a computer-generated random number sequence (www.random.org) to one of three groups:
- Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China)
- Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s):
- Oropharyngeal Leak Pressure (OLP).
- Demographic and Clinical Data.
- Hemodynamics.
- Insertion Data.
- Peak Airway Pressure (Ppeak).
- Fiberoptic Glottic View Assessment.
- Ultrasound Assessment of Gastric Insufflation.
- Perioperative Complications.bronchospasm, or sore throat.
- Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: Ambu AuraGain LMA | Active comparator | Device: supraglottic airway devicesupraglottic Airway device used for airway control |
| Group II: LarySeal Pro LMA | Active comparator | Device: supraglottic airway devicesupraglottic airway device used for airway control |
| Group III: I-gel | Active comparator | Device: supraglottic airway devicesupraglottic airway device used for airway control |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Age 2-9 years.
Key exclusion criteria (7 listed)
- • ASA Physical Status III or IV.
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 |
|---|---|---|
| supraglottic airway deviceuse of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation | Device | Group I: Ambu AuraGain LMA, Group II: LarySeal Pro LMA, Group III: I-gel |
Primary outcome
Oropharyngeal Leak Pressure (OLP)
Time frame: from enrollment to the end of the study at 6 months
3 secondary outcomes
Peak Airway Pressure (P peak)
Time frame: From enrollement to the end of the study at 6 months
Fiberoptic glottic airway view
Time frame: From enrollment to the end of the study at 6 months
Ultrasound Assessment of Gastric Insufflation
Time frame: From enrollement to the end of the study at 6 months
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 4 Aug 2026.
- educational and academic web pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographic and clinical data Insertion data of the SGAD (time, successfulness) OLP Ppeak Hemodynamic data Fiberoptic glottic view data Ultrasound assessment of gastric insufflation data Perioperative complication data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic airway device in people with Airway Control, run by Kasr El Aini Hospital 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 7 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 4 Aug 2026. 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) (time frame: from enrollment to the end of the study at 6 months). 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 4 Aug 2026.