Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia

Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Insufflation; General Anesthesia; Pediatric; Orthopedic Operations; I-gel; Ambu AuraGain
• Intervention / Treatment: Device: Ambu Auragain; Device: I-gel

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya N Farahat, MBBCH; Phone Number: 00201552122249; Email: aya.nabil311.nabil@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Shaimaa F Abdelkader, MD
      • Contact: Aya N Farahat, MBBCH; Phone Number: 00201552122249; Email: aya.nabil311.nabil@gmail.com
      • Sub-Investigator: Kamal E Hikel, MD
      • Sub-Investigator: Maram I Elmazny, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambu Auragain group; Ambu Auragain was inserted after induction.	Device: Ambu Auragain; Ambu Auragain was inserted after induction.
Experimental: I-gel group; The I-gel device was inserted after induction.	Device: I-gel; The I-gel device was inserted after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of surgery before supraglottic airway devices removal (5 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperatively
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.	Intraoperatively
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.	Intraoperatively
Incidence of postoperative complications	Incidence of postoperative complications such as mucosal injury, laryngeal spasm, hoarseness, nausea and vomiting were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): March 27, 2025
• Study Completion (Estimated): March 27, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36264MS287/8/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No