Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Gastric antrum cross-sectional area (CSA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ambu Auragain group
Ambu Auragain was inserted after induction.
Intervention: Ambu Auragain (Device)
I-gel group
The I-gel device was inserted after induction.
Intervention: I-gel (Device)
Outcomes
Primary Outcomes
Gastric antrum cross-sectional area (CSA)
Time Frame: At the end of surgery before supraglottic airway devices removal (5 min)
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(Intraoperatively)
- Time of insertion of supraglottic airway devices(Intraoperatively)
- Number of attempts for insertion(Intraoperatively)
- Incidence of postoperative complications(24 hours postoperatively)
Investigators
Aya Nabil Farahat
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University