Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation

Comparative Evaluation of Ambu AuraGain, LarySeal Pro LMA and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation: A Randomized Comparative Trial

This study aims to compare the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients aged 2-9 years, weighing 10-30 kg, American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for elective day-case surgery suitable for supraglottic airway device (SGAD) use.Patients will be randomly assigned (n= 55 per group) using a computer-generated random number sequence (www.random.org) to one of three groups:

• Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China)
• Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s):
• Oropharyngeal Leak Pressure (OLP).
• Demographic and Clinical Data.
• Hemodynamics.
• Insertion Data.
• Peak Airway Pressure (Ppeak).
• Fiberoptic Glottic View Assessment.
• Ultrasound Assessment of Gastric Insufflation.
• Perioperative Complications.bronchospasm, or sore throat.
• Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).

Study Overview

• Status: Active, not recruiting
• Conditions: Airway Control
• Intervention / Treatment: Device: supraglottic airway device

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • KasrAlainy Hospitals

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• • Age 2-9 years.

  • Weight 10-30 kg.
  • ASA Physical Status I or II.
  • Elective day-case surgery requiring general anesthesia with controlled ventilation using an SGAD.
  • Written informed consent from parent(s) or legal guardian(s).

Exclusion Criteria:

• • ASA Physical Status III or IV.

  • Known or predicted difficult airway.
  • History of significant respiratory disease (e.g., asthma requiring frequent medication, active upper respiratory tract infection, reactive airway disease within the past month).
  • History of significant gastroesophageal reflux, hiatal hernia, BMI ≥ 35, or other conditions predisposing to increased aspiration risk.
  • Neuromuscular disorders affecting airway patency or respiratory function.
  • Known allergy or contraindication to study devices or anesthetic medications.
  • Participation in other clinical trials that could influence study outcomes.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: Ambu AuraGain LMA; supraglottic Airway device used for airway control	Device: supraglottic airway device; use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Active Comparator: Group II: LarySeal Pro LMA; supraglottic airway device used for airway control	Device: supraglottic airway device; use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Active Comparator: Group III: I-gel; supraglottic airway device used for airway control	Device: supraglottic airway device; use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oropharyngeal Leak Pressure (OLP)	from enrollment to the end of the study at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak Airway Pressure (P peak)	From enrollement to the end of the study at 6 months
Fiberoptic glottic airway view	From enrollment to the end of the study at 6 months
Ultrasound Assessment of Gastric Insufflation	From enrollement to the end of the study at 6 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

Helpful Links

• educational and academic web page

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: N-288-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic and clinical data Insertion data of the SGAD (time, successfulness) OLP Ppeak Hemodynamic data Fiberoptic glottic view data Ultrasound assessment of gastric insufflation data Perioperative complication data
• IPD Sharing Time Frame: January 2025 - january 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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