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
Submission date
24/08/2009
Registration date
11/11/2009
Last edited
11/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
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

Contact information

Prof Robert Greif
Scientific

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

Study information

Study designProspective randomised gold-standard controlled single-blinded (patient) trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet (in German)
Scientific titleComparison of the laryngeal mask airway Ambu Aura Once™ and the i-gel™ in elective anaesthetised and ventilated paediatric patients
Study acronymPaediatric i-gel
Study objectivesH0 = 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) studiedAirway management in paediatric patients
InterventionAccording 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 typeOther
Primary outcome measureOropharyngeal leak pressure
Secondary outcome measures1. 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 date15/08/2009
Completion date15/08/2010

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit17 Years
SexBoth
Target number of participants240
Key inclusion criteria1. 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 criteria1. 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 enrolment15/08/2009
Date of final enrolment15/08/2010

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Inselspital, University Hospital Bern
Bern
CH-3010
Switzerland

Sponsor information

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 logo "ROR" https://ror.org/01q9sj412

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan