About this trial
Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ambu Auragain
DeviceAmbu Auragain was inserted after induction.
I-gel
DeviceThe I-gel device was inserted after induction.
Treatment groups
Trial outcomes
Primary outcomes
Gastric antrum cross-sectional area (CSA)
Gastric antrum cross-sectional area (CSA) was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, after Ryle's tube insertion, and at the end of surgery before SAD removal.
Secondary outcomes
Oropharyngeal leak pressure
Oropharyngeal leak pressure was determined after confirmation of adequate device insertion and secure taping by closing the adjustable pressure-limiting (APL) valve with a fresh gas flow of 3 l/min and observing the airway pressure at which equilibrium was attained in the aneroid manometer (airway pressure was not allowed to exceed 40cmH2O) or when there was audible air leak from the throat which was auscultated in the neck with a stethoscope placed just beside the thyroid cartilage.
Time of insertion of supraglottic airway devices
Insertion time was measured in seconds and counted from the time of opening the jaw to the appearance of the capnography waveform.
Number of attempts for insertion
Three insertion attempts were allowed. Each 'attempt' was defined as reinsertion of the airway device into the mouth. Insertion failure of the device was defined as greater than three unsuccessful attempts or if the entire process of insertion exceeded 120 seconds.
Incidence of postoperative complications
Incidence of postoperative complications such as mucosal injury, laryngeal spasm, hoarseness, nausea and vomiting were recorded.
Sponsors and contacts
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