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

Completed

• Conditions: Airway management in paediatric patients; Respiratory

• Registration Number: ISRCTN64997093
• Lead Sponsor: Inselspital, University Hospital Bern (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified