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

ISRCTN	ISRCTN64997093
DOI	https://doi.org/10.1186/ISRCTN64997093
Secondary identifying numbers	KEK018/08

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

Study design	Prospective randomised gold-standard controlled single-blinded (patient) trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (in German)
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	Oropharyngeal leak pressure
Secondary outcome measures	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
Overall study start date	15/08/2009
Completion date	15/08/2010

Participant type(s)	Patient
Age group	Child
Upper age limit	17 Years
Sex	Both
Target number of participants	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

Inselspital, University Hospital Bern (Switzerland)
Hospital/treatment centre

Department of Anesthesiology
Bern
CH-3010
Switzerland

Phone	+41 (0)31 632 2111
Email	robert.greif@insel.ch
Website	http://www.anaesthesie.insel.ch
"ROR"	https://ror.org/01q9sj412

Hospital/treatment centre

Inselspital, University Hospital Bern (Switzerland), Departmental Research Fund

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan