Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

December 4, 2015

Completed

28 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed

9 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed

Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

December 4, 2015

Last Update Submit

December 21, 2017

Conditions

Airway Management Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

oropharyngeal leak pressure
If successful ventilation is achieved with the device, the investigator will measure OLP by closing the Adjustable Pressure Limiting valve on the anaesthetic machine; with a fresh gas flow of 3l/min. Pressure at which equilibrium is reached will be deemed the OLP. Pressure will not be allowed to exceed 40cmH20.
Up to 3 minutes of successful insertion of each device

Secondary Outcomes (7)

Ease of insertion
Up to 1 minute on each insertion attempt
Number of attempts required to insert
Up to 1 minute of completion of total insertion attempts
Evidence of Airway Trauma
Up to 1 minute after removal of first device used
Adequacy of positive pressure ventilation
Up to 1 minute after successful insertion of device and after completion of outcome 4 measurement
Fibreoptic assessment of device position
Up to 5 minutes after successful insertion and after completion of outcome 5 measurement
+2 more secondary outcomes

Study Arms (2)

i-Gel and AuraGain

ACTIVE COMPARATOR

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

Device: Insertion of Ambu AuraGain laryngeal mask airway and IgelDevice: Fibreoptic assessment with Ambu A-scopeDevice: Ability to insert nasogastric tubeDevice: Measurement of OLPDevice: Ability to perform positive pressure ventilationDevice: Assessment of ease of insertionDevice: Record number of manipulationsDevice: Assessment of device related trauma

AuraGain and i-Gel

ACTIVE COMPARATOR

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

Interventions

Insertion of Ambu AuraGain laryngeal mask airway and IgelDEVICE

Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction