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Paediatric i-gel™ laryngeal masks compared with the Ambu Aura Once™ laryngeal mask

Comparison of the laryngeal mask airway Ambu Aura Once™ and the i-gel™ in elective anaesthetised and ventilated paediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64997093
Enrollment
240
Registered
2009-11-11
Start date
2009-08-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway management in paediatric patients Respiratory

Interventions

According to randomisation, patients will be ventilated by either one of the masks involved in the study: either the paediatric sized i-gel™ or the paediatric sized Ambu Aura Once™. No other intervent

Sponsors

Inselspital, University Hospital Bern (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients of both genders, aged 0-17 years 2. Weight of 5-50 kg 3. American Society of Anaesthesiologists (ASA) physical status I-II 4. Scheduled at the University Hospital of Bern for elective surgery planned for general anaesthesia not requiring tracheal intubation

Exclusion criteria

Exclusion criteria: 1. Planned operation time >4h 2. Risk of aspiration (non-fasted, massive gastroesophageal reflux disease, gastrointestinal stenosis or stricture) 3. Known difficult airway (difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane grade >2) 4. Congenital malformations involving the respiratory tract 5. Cervical spine disease 6. Upper respiratory tract symptoms in the previous 14 days 7. Preoperative sore throat 8. Patients with non-German-speaking parents or refusing to participate

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure

Secondary

MeasureTime frame
1. First attempt success rate 2. Time necessary for completion of first attempt 3. Insertion success of a gastric catheter 4. Fiberoptic laryngeal view 5. Adverse events

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026