Condition category
Respiratory
Date applied
24/08/2009
Date assigned
11/11/2009
Last edited
11/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert Greif

ORCID ID

Contact details

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

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 measures

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

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

http://www.anaesthesie.insel.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes