NCT02644837

AuraGain and iGel Crossover Comparison

Randomised Crossover Comparison of the Ambu AuraGain and the iGel in Anaesthetised Adults

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: NHS Tayside · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at key performance indicators of 2 supraglottic airway devices in anaesthetised adults in a crossover manner.

Detailed description

A supraglottic airway device (SAD), also referred to as laryngeal mask airway (LMA), is a medical device that maintains a patients airway, allowing unobstructed ventilation during anaesthesia. They are designed to sit in the patient's hypopharynx (throat), with their elliptical head forming a seal around the supraglottic structures (the patients "voice box"). They have been in common use since 1989, transforming anaesthetic practice and are now the predominant airway device within anaesthesia, being used in approximately 56% of all general anaesthetic cases in the UK(1). Their popularity for routine use stems from its perceived benefits over traditional forms of airway management coupled with their high overall success rate and low complication rate. SADs, in anaesthetic practice, are inserted after induction of general anaesthesia, by or under supervision of, a trained medical professional. All patients are fully monitored as set out by the Association of Anaesthetist of Great Britain and Ireland; Recommendations for standards of monitoring during anaesthesia and recovery (2). Devices are used in concordance with manufacturer instruction. Successful first time placement is achieved in a large majority of patients and allows provision of oxygen and ventilation. In some patients, one device or size of device may present sub-optimal performance resulting in the removal of the device. Further actions in this scenario would include attempting a second insertion of the same device, attempting an insertion with an alternative size of the same device or a further attempt with an alterative design of device in order to achieve a patent airway. Further attempts may be taken but should be limited to avoid unnecessary trauma. In some cases the use of the SAD is abandoned and the patient is intubated with an endotracheal tube in order to provide a safe secure airway. Alternatives to use of a SAD for airway management include use of a simple facemask or tracheal intubation with an endotracheal tube. Advantages of using a SAD for anaesthetic airway management compared to a facemask are improved oxygen saturation and less operator/anaesthetist fatigue. Compared to an endotracheal tube the advantages of using a SAD are improved haemodynamic stability at induction and emergence from anaesthesia, reduced anaesthetic requirements, improved quality of emergence, lower incidence of sore throat, increased ease of placement and reduced risk of dental damage. Risks of using an LMA compared to an endotracheal tube are increased gastric insufflation and aspiration with these being more common in patients who are poorly selected for anaesthesia with a SAD. Sore throat is the most common complication with a study There have been significant developments in design in the SAD market in recent years with development of a "second generation" range of devices involving new materials and designs that integrate protective bite blocks, gastric drainage channels and improved supraglottic seal enhancing patient safety when using these devices. There are now some new "third generation" SADs on the market with designs that may enhance anaesthetic practice and improve patient safety further. This study will follow similar ethically approved protocols used in published studies comparing airway equipment (3,4). These are only 2 examples but there are hundreds of LMA studies throughout the literature. The Ambu AuraGain is a new device and has not been studied fully. Comparative studies frequently assess oropharyngeal leak pressure (OLP), a fibre optic assessment of glottic alignment, ease of insertion, ability to insert a nasogastric tube down the gastric port and frequency of manipulations. We propose a crossover design to better detect differences between the two devices as this eliminates confounding differences in patient characteristics and demographics. There have been significant developments in design in the SAD market in recent years with 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 with their use. The AuraGain is a new device on the market and has not been compared to other devices yet.

Conditions

• Airway Management
• Laryngeal Mask Airway

Interventions

Type	Name	Description
DEVICE	Insertion of Ambu AuraGain laryngeal mask airway and Igel	Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction
DEVICE	Fibreoptic assessment with Ambu A-scope	Passage of Ambu a-scope fibrescope down shaft of laryngeal mask airway and assessment of alignment with glottis in relation to amount of glottis that is easily visualised
DEVICE	Ability to insert nasogastric tube	Passage of nasogastric tube down the gastric drainage channel of the device in accordance with manufacturer guidance
DEVICE	Measurement of OLP	Measurement of OLP by closing the adjustable pressure limiting valve against a constant fresh gas flow rate of 3 litres/minute
DEVICE	Ability to perform positive pressure ventilation	The ability to deliver 6 mls/kg volumes breaths by means of positive pressure ventilation will be assessed
DEVICE	Assessment of ease of insertion	Ease of insertion will be subjectively assessed by operator in relation to presence and nature of resistance to insertion of the device
DEVICE	Record number of manipulations	The number of manipulations/adjustments will be recorded for the second device only for the remainder of the device use during surgery until the patient wakes.
DEVICE	Assessment of device related trauma	Observation and assessment of any trauma caused by the insertion of the first device used

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-01-01
• Last updated: 2017-12-26

Locations

1 site across 1 country: United Kingdom