Comparing airway devices in children undergoing orthopedic surgery
Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06853756 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the use of supraglottic airway devices is common, this specific comparison of Ambu AuraGain and i-gel in pediatric patients is relatively novel.
Eligibility criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Aya N Farahat, MBBCH
- Email: aya.nabil311.nabil@gmail.com
- Phone: 00201552122249
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.