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
Scientific
Inselspital, University Hospital Bern
Department of Anaesthesiology
Bern
CH-3010
Switzerland
Study information
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 |
Eligibility
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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Inselspital, University Hospital Bern
Bern
CH-3010
Switzerland
CH-3010
Switzerland
Sponsor information
Inselspital, University Hospital Bern (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
Bern
CH-3010
Switzerland
Phone | +41 (0)31 632 2111 |
---|---|
robert.greif@insel.ch | |
Website | http://www.anaesthesie.insel.ch |
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 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 |