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 type | Interventional |
|---|---|
| Ages | 2 Years to 12 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | March 27, 2025 |
| Study ends | March 27, 2025 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06853756 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
- Study coordinator: Aya N Farahat, MBBCH
- Email: aya.nabil311.nabil@gmail.com
- Phone: 00201552122249
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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.