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NCT Number: NCT07274280

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Airway Control

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KasrAlainy Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supraglottic airway device

Device

use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation

Primary outcomes

  1. Oropharyngeal Leak Pressure (OLP)

    Time frame: from enrollment to the end of the study at 6 months

Secondary outcomes

  1. Peak Airway Pressure (P peak)

    Time frame: From enrollement to the end of the study at 6 months

  2. Fiberoptic glottic airway view

    Time frame: From enrollment to the end of the study at 6 months

  3. Ultrasound Assessment of Gastric Insufflation

    Time frame: From enrollement to the end of the study at 6 months

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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