Comparing stomach air with LarySeal Pro versus Ambu AuraGain in children under general anesthesia
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07451470 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Cairo Governorate
- Cairo Universty — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: dr mahmoud abdeltawab gbre, lectrer MD
- Email: mahmoud15588@gmail.com
- Phone: +020109772251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.