Comparing stomach air with LarySeal Pro versus Ambu AuraGain in children under general anesthesia
Official title: Comparison of Gastric Insufflation Volume Between LarySeal Pro and Ambu AuraGain Using Ultrasonography In Pediatric Patients Undergoing General Anesthesia With Controlled Ventilation. A Randomized Controlled Trial.
Run by Cairo University · NCT07451470 · Data updated 2026-11-12
This trial tests whether the LarySeal Pro or the Ambu AuraGain leads to less air in the stomach of children having short elective surgeries with controlled ventilation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 10 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | September 2026 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT07451470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged approximately 6–12 years undergoing elective short procedures (about 1 hour or less) with Mallampati I–II and ASA I–II are the intended participants.
✕Probably not a fit
Patients with gastroesophageal reflux, abnormal airway anatomy, active respiratory infection, significant cardiac disease, or other exclusion criteria are not eligible and would not be expected to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled trial at Cairo University comparing two supraglottic airway devices (LarySeal Pro and Ambu AuraGain) in pediatric patients. Children meeting inclusion criteria are randomized with computer-generated numbers and sealed envelopes into two equal groups for device insertion during general anesthesia with controlled ventilation. Gastric insufflation will be measured using bedside gastric ultrasonography, with ventilation performed under low pressure (<20 cmH2O) and standardized insertion technique. The primary comparison is the volume/extent of gastric air visualized after device placement and during ventilation.
Why it matters
Potential benefit: If successful, the preferred device could reduce stomach air, lowering the risk of regurgitation, aspiration, and postoperative abdominal distension in pediatric anesthesia.
How similar studies have gone: Previous comparisons of supraglottic airway devices have shown differences in seal and gastric insufflation, but direct pediatric comparisons between LarySeal Pro and Ambu AuraGain are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age: pediatrics (6-12years ) * Patients with a Mallampati score of I - II * Elective surgeries * Short procedure expected to last for 1 hour or less . * ASA I - II Exclusion Criteria: * • Age: below 6 years and above 12 years * Patient with airway masses * Active upper respiratory tract infections, pneumonia, COPD \& exacerbated bronchial asthma. * Patient with gastroesophgeal reflux ( hiatus hernia , achalasia ) * Patient with abnormal airway anatomy * Coagulation disorders. * Patients with any cardiac conditions (IHD, RHD, decompensated heart failure and arrhythmia).
Where it's running
-
Cairo Universty
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: dr mahmoud abdeltawab gbre, lectrer MD
- Email: mahmoud15588@gmail.com
- Phone: +020109772251
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Gastric Volume Changes in Kids During Ventilation With Different Airway Devices
This study tests whether gastric volume in children changes depending on whether they are ventilated with an endotracheal tube or with one of two supraglottic airway devices.
-
Comparing airway devices in children undergoing orthopedic surgery
This study is testing which of two airway devices, Ambu AuraGain or i-gel, works better and safer for kids having orthopedic surgery under general anesthesia.
-
Delphi consensus to guide mechanical insufflation-exsufflation use in the ICU
A panel of ICU and lung specialists will use a structured survey process to agree on best practices for using mechanical insufflation-exsufflation to help airway clearance in critically ill patients.
-
Predicting successful extubation in children using high-velocity nasal insufflation versus simple nasal oxygen
This will test whether high-velocity nasal insufflation or simple nasal oxygen leads to fewer re-intubations or breathing problems after planned extubation in children ready to come off a ventilator.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.