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

ISRCTN	ISRCTN64997093
DOI	https://doi.org/10.1186/ISRCTN64997093
Protocol serial number	KEK018/08
Sponsor	Inselspital, University Hospital Bern (Switzerland)
Funder	Inselspital, University Hospital Bern (Switzerland), Departmental Research Fund

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Robert Greif
Scientific

Inselspital, University Hospital Bern
Department of Anaesthesiology
Bern
CH-3010
Switzerland

Primary study design	Interventional
Study design	Prospective randomised gold-standard controlled single-blinded (patient) trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of the laryngeal mask airway Ambu Aura Once™ and the i-gel™ in elective anaesthetised and ventilated paediatric patients
Study acronym	Paediatric i-gel
Study objectives	H0 = Mean Airway seal pressure Ambu ≥ Mean Airway seal pressure i-gel. H1 = Mean Airway seal pressure Ambu < Mean Airway seal pressure i-gel.
Ethics approval(s)	Ethics Committee of Berne, approved on 02/02/2009 (ref: 018/09)
Health condition(s) or problem(s) studied	Airway management in paediatric patients
Intervention	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 interventions.
Intervention type	Other
Primary outcome measure(s)	Oropharyngeal leak pressure
Key secondary outcome measure(s)	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
Completion date	15/08/2010

Participant type(s)	Patient
Age group	Child
Upper age limit	17 Years
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	15/08/2009
Date of final enrolment	15/08/2010

Inselspital, University Hospital Bern

Bern
CH-3010
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes