Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia
Launched by TANTA UNIVERSITY · Feb 25, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different devices, the I-gel and Ambu AuraGain, used to help children breathe during orthopedic surgeries while they are under general anesthesia. The study aims to see how much air can be safely put into the stomach using each device and how this affects the pressure in the throat area and any complications that might happen after surgery.
To be part of this trial, children must be between 2 and 12 years old and scheduled for specific types of orthopedic surgeries. They also need to be in good health, classified as ASA physical status I or II, which means they have no serious medical issues. However, children with certain conditions, like reflux problems or a history of breathing issues, cannot participate. If your child qualifies and chooses to join, they will receive one of the two devices during their surgery, and the doctors will monitor their recovery closely. This study aims to improve care and safety for young patients undergoing surgery.
Gender
ALL
Eligibility 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.
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tanta, El Gharbia, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported