Clinical trial Recruiting at 1 site Interventional Ages 6 to 10

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.

More Gastric Insufflation trials

Quick facts

Study typeInterventional
Ages6 Years to 10 Years
SexAll
Enrollment106 (estimated)
SponsorCairo University
Academic / other
Locations1 site (Cairo, Cairo Governorate)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedJune 1, 2026
Study endsSeptember 2026
Registry record updatedMarch 5, 2026
Trial IDNCT07451470 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.