Ambu Auragain - i-gel comparison study version 1.1
Research type
Research Study
Full title
Randomised crossover comparison between the Ambu Auragain and i-gel in anaesthesied patients.
IRAS ID
190517
Contact name
Simon Crawley
Contact email
Sponsor organisation
University of Dundee
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
A supraglottic airway device (SAD) is a medical device that maintains a patient’s airway, allowing unobstructed ventilation during anaesthesia. They have been in common use since 1989 and are now the predominant airway device within anaesthesia.
There have been significant developments in design in the SAD market in recent years with development of a “second generation” range that integrate protective bite blocks, gastric drainage channels and improved supraglottic seal enhancing patient safety. There are now new “third generation” SADs on the market that may enhance anaesthetic practice and improve patient safety further.
Our proposal would be to carry out a randomised crossover comparison between a new “third generation” SAD; the AuraGainTM (Ambu, Copenhagen, Denmark) and our current “second generation” SAD; the i-gel (Intersurgical Ltd, Wokingham, UK) to examine and compare key performance indicators. The hypothesis is that the Ambu AuraGain is superior to the i-Gel in relation to achieving a high oesophageal seal pressure/better fit and thus improving its overall performance for oxygenation, ventilation and protection against aspiration during anaesthesia.
The proposed study will involve adults (age >18 years) undergoing general anaesthesia when a SAD is planned as the first line airway management device.
Patients will be anaesthetised within Ninewells Hospital, Perth Royal Infirmary and Stracathro Regional Treatment Centre.
The intervention phase will last for the duration of the patients’ time under general anaesthesia. The main portion will be after induction and is estimated to take 10 minutes. As we are also measuring number of intraoperative manipulations during surgery; the overall intervention time will be variable between participants depending on the nature of their surgery so may be as long as 2 hours but this will be observation only and adjustment which would fall under standard care.
The study will recruit for a period of 12 months or until 46 patients have been recruited.REC name
East of Scotland Research Ethics Service REC 1
REC reference
16/ES/0022
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion