AuraGain and iGel Crossover Comparison

Summary

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

Conditions

• Airway Management
• Laryngeal Mask Airway

Interventions

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

Sponsors & Collaborators

• NHS Tayside

  lead OTHER_GOV

Principal Investigators

• Simon M Crawley, MBChB FRCA · Consultant Anaesthetist

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2017-05-31

Completion

2017-08-31

Countries

• United Kingdom

Study Locations