Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2016-10-31
2017-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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i-Gel and AuraGain
In this arm of the crossover study, patients will undergo insertion of Ambu AuraGain laryngeal mask airway and iGel and will undergo initial management with the iGel. Primary and Secondary outcomes will be assessed. The initial device will be removed and subsequent Airway management will then be undertaken with the Ambu AuraGain and the same outcomes will be assessed.
Interventions with both devices will be
1. Insertion of the laryngeal mask airway
2. Assessment of ease of insertion
3. Ability to perform positive pressure ventilation
4. Measurement of OLP
5. Fibreoptic assessment with Ambu A-scope
6. Ability to insert nasogastric tube
7. Record number of manipulations
8. An assessment of device related trauma
Insertion of Ambu AuraGain laryngeal mask airway and Igel
Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction
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
Ability to insert nasogastric tube
Passage of nasogastric tube down the gastric drainage channel of the device in accordance with manufacturer guidance
Measurement of OLP
Measurement of OLP by closing the adjustable pressure limiting valve against a constant fresh gas flow rate of 3 litres/minute
Ability to perform positive pressure ventilation
The ability to deliver 6 mls/kg volumes breaths by means of positive pressure ventilation will be assessed
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
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.
Assessment of device related trauma
Observation and assessment of any trauma caused by the insertion of the first device used
AuraGain and i-Gel
In this arm of the crossover study, patients will undergo insertion of the Ambu AuraGain laryngeal mask airway and i-Gel and will undergo initial management with the Ambu AuraGain.. Primary and Secondary outcomes will be assessed. Airway management will then be undertaken with the iGel device and the same outcomes will be assessed.
Interventions with both devices will be
1. Insertion of the laryngeal mask airway
2. Assessment of ease of insertion
3. Ability to perform positive pressure ventilation
4. Measurement of OLP
5. Fibreoptic assessment with Ambu A-scope
6. Ability to insert nasogastric tube
7. Record number of manipulations
8. An assessment of device related trauma
Insertion of Ambu AuraGain laryngeal mask airway and Igel
Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction
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
Ability to insert nasogastric tube
Passage of nasogastric tube down the gastric drainage channel of the device in accordance with manufacturer guidance
Measurement of OLP
Measurement of OLP by closing the adjustable pressure limiting valve against a constant fresh gas flow rate of 3 litres/minute
Ability to perform positive pressure ventilation
The ability to deliver 6 mls/kg volumes breaths by means of positive pressure ventilation will be assessed
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
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.
Assessment of device related trauma
Observation and assessment of any trauma caused by the insertion of the first device used
Interventions
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Insertion of Ambu AuraGain laryngeal mask airway and Igel
Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction
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
Ability to insert nasogastric tube
Passage of nasogastric tube down the gastric drainage channel of the device in accordance with manufacturer guidance
Measurement of OLP
Measurement of OLP by closing the adjustable pressure limiting valve against a constant fresh gas flow rate of 3 litres/minute
Ability to perform positive pressure ventilation
The ability to deliver 6 mls/kg volumes breaths by means of positive pressure ventilation will be assessed
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
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.
Assessment of device related trauma
Observation and assessment of any trauma caused by the insertion of the first device used
Eligibility Criteria
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Inclusion Criteria
* patients whose anaesthesia management is being carried out by one of the named investigators
* adult (age \>18 years) patients undergoing general anaesthesia
* American Society of Anaesthesiology Grading (ASA) 1-3
* suitability for general anaesthesia using a laryngeal mask airway device
Exclusion Criteria
* pathology of neck or upper respiratory tract
* an identified or anticipated difficult intubation
* an increased risk of aspiration (hiatus hernia, gastro-oesophageal reflux or full stomach etc.) pregnant women
* a body mass index greater than 35kg.m-2
* patients unable to communicate fully in English.
18 Years
ALL
No
Sponsors
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NHS Tayside
OTHER_GOV
Responsible Party
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Principal Investigators
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Simon M Crawley, MBChB FRCA
Role: PRINCIPAL_INVESTIGATOR
Consultant Anaesthetist
Locations
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Ninewells Hospital
Dundee, Angus, United Kingdom
Countries
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Other Identifiers
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2015AN07
Identifier Type: -
Identifier Source: org_study_id