Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ambu Auragain, I-gel.
- Who it may be relevant to
- Registry conditions: Gastric Insufflation, I-gel, Ambu AuraGain, Pediatric. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).
Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.
Interventions
- Device Ambu Auragain
Ambu Auragain was inserted after induction. - Device I-gel
The I-gel device was inserted after induction.
Primary outcome measures
- Gastric antrum cross-sectional area (CSA) [Time frame: At the end of surgery before supraglottic airway devices removal (5 min)]
Secondary outcome measures (4)
- Oropharyngeal leak pressure [Time frame: Intraoperatively]
- Time of insertion of supraglottic airway devices [Time frame: Intraoperatively]
- Number of attempts for insertion [Time frame: Intraoperatively]
- Incidence of postoperative complications [Time frame: 24 hours postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT06853756 · 36264MS287/8/23