None listed
Conditions
Brief summary
To ensure the safe delivery of oxygen and anaesthesia gases to a child, the anaesthetist will insert a tube into the child’s mouth. There are two tubes which can be used for this purpose. Both look very similar and do the same thing. One type of tube, the laryngeal mask, has an inflatable soft silicone cuff at the end while the other, called an Igel, has a non-inflatable cuff made of soft gel. Both devices have been independently shown to be safe in children’s anaesthesia. However, a direct comparison between the two devices is lacking in the paediatric population, which we are doing.
Interventions
Patients are randomised to receive either an Laryngeal Mask Airway or an igel Airway.
Both devices will be inserted into the mouth using the same technique.
The laryngeal mask airway has an inflatable cuff while the igel has a soft gel cuff.
They will be utilised for the length of the procedure the patient is undergoing (normally 1-4 hours)
Sponsors
Princess Margaret Hospital for Children
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
Inclusion criteria
0-16 years elective surgery not involveing the airway weight > 5kg, < 60 kg No contraindications for use of supraglottic airway device as determined by anaesthetist independent of the study team
Exclusion criteria
Contraindications for use of supraglottic airway device as determined by anaesthetist independent of the study team, airway malformations, surgery involving the airway Weight < 5kg or > 60 kg
Outcome results
None listed