Clinical trial Recruiting at 1 site Interventional Ages 2 to 12

Comparing airway devices in children undergoing orthopedic surgery

Official title: Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial

Run by Tanta University · NCT06853756 · Data updated 2026-11-12

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.

Quick facts

Study typeInterventional
Ages2 Years to 12 Years
SexAll
Enrollment60 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedAugust 1, 2023
Main results expectedMarch 27, 2025
Study endsMarch 27, 2025
Registry record updatedMarch 3, 2025
Trial IDNCT06853756 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 2 to 12 years scheduled for elective orthopedic operations under general anesthesia with ASA physical status I and II.

Probably not a fit

Patients with a history of gastro-oesophageal reflux disorders, full stomach, or anticipated difficult airway management may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the gastric insufflation volume between two supraglottic airway devices, Ambu AuraGain and i-gel, in pediatric patients undergoing elective orthopedic surgeries under general anesthesia. It evaluates the relationship between the devices' performance, measured by oropharyngeal sealing pressure, and the incidence of postoperative complications. The goal is to determine which device provides better safety and efficacy in managing airway during surgery.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of airway management in pediatric orthopedic surgeries.

How similar studies have gone: While the use of supraglottic airway devices is common, this specific comparison of Ambu AuraGain and i-gel in pediatric patients is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Aged from 2 to 12 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Scheduled for elective orthopedic operations in a supine position under general anesthesia.

Exclusion Criteria:

* Patients with a known history of gastro-oesophageal reflux disorders.
* Full Stomach.
* Anticipated difficult mask ventilation or intubation.
* Body mass index "BMI" exceeding 20% of the ideal.
* A history of chest problems.
* History of the gastrointestinal tract or thoracic surgeries.

Where it's running

  • Tanta University
    Tanta, El-Gharbia, 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.