Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation
1 other identifier
interventional
165
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedFirst Posted
Study publicly available on registry
December 10, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
April 21, 2026
April 1, 2026
6 months
November 27, 2025
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Oropharyngeal Leak Pressure (OLP)
from enrollment to the end of the study at 6 months
Secondary Outcomes (3)
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
Study Arms (3)
Group I: Ambu AuraGain LMA
ACTIVE COMPARATORsupraglottic Airway device used for airway control
Group II: LarySeal Pro LMA
ACTIVE COMPARATORsupraglottic airway device used for airway control
Group III: I-gel
ACTIVE COMPARATORsupraglottic airway device used for airway control
Interventions
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KasrAlainy Hospitals
Cairo, Egypt
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia, Surgical Intensive Care and Pain Management
Study Record Dates
First Submitted
November 27, 2025
First Posted
December 10, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 15, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- January 2025 - january 2026
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