Actively Recruiting
Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
Led by Tanta University · Updated on 2025-03-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of supraglottic airway devices, Ambu AuraGain and I-gel, in children aged 2 to 12 years undergoing elective orthopedic surgery under general anesthesia. The study focuses on measuring gastric insufflation volume and its relationship with oropharyngeal sealing pressure, which indicates how well the airway device seals and the risk of complications after surgery. Participants will be randomly assigned to receive either the Ambu AuraGain device or the I-gel device after anesthesia induction. Both devices serve as pathways for oxygen and anesthetic gases during surgery. The study evaluates outcomes like gastric antrum cross-sectional area at the end of surgery, leak pressure during the operation, time and attempts needed for insertion, and any postoperative complications within 24 hours. During the study, children will be monitored with assessments including ultrasound to measure the stomach area and tests for airway sealing pressure. Researchers will record details about device insertion and watch for any complications after surgery. Participation involves close observation during and shortly after surgery, with total involvement lasting through the surgical procedure and 24 hours afterward.
CONDITIONS
Brief Title
Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Known history of gastro-oesophageal reflux disorders.
- Full stomach condition.
- Anticipated difficult mask ventilation or intubation.
- Body mass index exceeding 20% of the ideal.
- History of chest problems.
- History of gastrointestinal tract or thoracic surgeries.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of the surgery
Participants undergo insertion of a supraglottic airway device (Ambu Auragain or I-gel) after induction of general anesthesia during elective orthopedic surgery.
1 visit (in-person) during surgery
Duration - 24 hours postoperatively
Participants are monitored for postoperative complications following the surgery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Aya N Farahat, MBBCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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