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

Kasr El Aini Hospital

Status: Not yet enrolling

Conditions: Airway Control

Treatments: Device: supraglottic airway device

Study type: Interventional

Funder types: Other

Identifiers

NCT07274280

N-288-2025

Details and patient eligibility

About

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).

Enrollment: 165 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 3 patient groups

Group I: Ambu AuraGain LMA

Active Comparator group

Description:

supraglottic Airway device used for airway control

Treatment:

Device: supraglottic airway device

Group II: LarySeal Pro LMA

Active Comparator group

Description:

supraglottic airway device used for airway control

Treatment:

Device: supraglottic airway device

Group III: I-gel

Active Comparator group

Description:

supraglottic airway device used for airway control

Treatment:

Device: supraglottic airway device