Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KEK018/08
Study information
Scientific title
Comparison of the laryngeal mask airway Ambu Aura Once™ and the i-gel™ in elective anaesthetised and ventilated paediatric patients
Acronym
Paediatric i-gel
Study hypothesis
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
Ethics Committee of Berne, approved on 02/02/2009 (ref: 018/09)
Study design
Prospective randomised gold-standard controlled single-blinded (patient) trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (in German)
Condition
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
Phase
Not Specified
Drug names
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 trial start date
15/08/2009
Overall trial end date
15/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
15/08/2009
Recruitment end date
15/08/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
Inselspital, University Hospital Bern
Bern
CH-3010
Switzerland
Sponsor information
Organisation
Inselspital, University Hospital Bern (Switzerland)
Sponsor details
Department of Anesthesiology
Bern
CH-3010
Switzerland
+41 (0)31 632 2111
robert.greif@insel.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Inselspital, University Hospital Bern (Switzerland), Departmental Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list