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Trial registered on ANZCTR


Registration number
ACTRN12611000037909
Ethics application status
Approved
Date submitted
11/01/2011
Date registered
11/01/2011
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Performance of two commonly used supraglottic airway devices in paediatric anaesthesia: laryngeal mask airway vs i-Gel
– a randomized controlled trial
Scientific title
Performance of two commonly used supraglottic airway devices in paediatric anaesthesia: laryngeal mask airway vs i-Gel
– a randomized controlled trial
Secondary ID [1] 253390 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supraglottic airway - comparison between Laryngeal Mask Airway and iGel 260944 0
Condition category
Condition code
Anaesthesiology 259077 259077 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 257835 0
Treatment: Devices
Comparator / control treatment
Laryngeal mask airway: control
Control group
Active

Outcomes
Primary outcome [1] 259933 0
Amount of leakage around the cuff of the supraglottic airway device in ml/kg as defined in the difference between the inspiratory and expiratory tidal volume
Timepoint [1] 259933 0
prior to surgery
Secondary outcome [1] 268838 0
Incidence of sore throat
Outcome will be assessed via a facial pain scale or in older patients a VAS-Scale
Timepoint [1] 268838 0
3-5 hours post surgery
Secondary outcome [2] 268839 0
Incidence of airway trauma (e.g. blood staining)
Assessed via observation of the patient
Timepoint [2] 268839 0
on removal of the device

Eligibility
Key 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
Minimum age
0 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will be recruited at the pre-anaesthetic visit. Only patients who meet the inclusion criteria for the study will be enrolled and only after informed consent is given voluntarily by the parent/guardian. The patients will be randomised by computer generated block randomisation. The participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomised by computer generated block randomisation. Following written informed consent, the participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 258304 0
Hospital
Name [1] 258304 0
Princess Margaret Hospital for Children
Address [1] 258304 0
Roberts Road
SUBIACO, WA 6008
Country [1] 258304 0
Australia
Funding source category [2] 288381 0
Charities/Societies/Foundations
Name [2] 288381 0
Princess Margaret Hospital Foundation
Address [2] 288381 0
68 Hay Street
Subiaco
WA 6008
Country [2] 288381 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Road
SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 257468 0
University
Name [1] 257468 0
School of Medicine and Pharmacolgy
Address [1] 257468 0
University of Western Australia
35 Stirling Highway
Crawley, Perth
Western Australia 6009
Country [1] 257468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260293 0
Child and Adolescent Health Campus Ethics Committee
Ethics committee address [1] 260293 0
Princess Margaret Hospital for Children
Roberts Road, SUBIACO, WA 6008
Ethics committee country [1] 260293 0
Australia
Date submitted for ethics approval [1] 260293 0
17/01/2011
Approval date [1] 260293 0
22/03/2011
Ethics approval number [1] 260293 0
1876 EP

Summary
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.
Trial website
Trial related presentations / publications
Anaesthesia. 2015 Dec;70(12):1412-7. doi: 10.1111/anae.13206. Epub 2015 Sep 10.
A comparison of the i-gel(™) and the PRO-Breathe(®) laryngeal mask during pressure support ventilation in children.
Drake-Brockman TF1,2, Ledowski T3, Hegarty M1, Gessner M1, von Ungern-Sternberg BS1,3.
Public notes

Contacts
Principal investigator
Name 32081 0
Prof Britta Regli-von Ungern-Sternberg
Address 32081 0
Department of Anaesthesia and Pain management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country 32081 0
Australia
Phone 32081 0
+61893408109
Fax 32081 0
Email 32081 0
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 15328 0
Prof Britta Regli-von Ungern
Address 15328 0
Chair of Paediatric Anaesthesia
Princess Margaret Hospital for Children
Roberts Road
SUBIACO, WA 6008
Country 15328 0
Australia
Phone 15328 0
+61893408109
Fax 15328 0
Email 15328 0
britta.regli-vonungern@health.wa.gov.au
Contact person for scientific queries
Name 6256 0
Prof Britta Regli-von Ungern
Address 6256 0
Chair of Paediatric Anaesthesia
Princess Margaret Hospital for Children
Roberts Road
SUBIACO, WA 6008
Country 6256 0
Australia
Phone 6256 0
+61893408109
Fax 6256 0
Email 6256 0
britta.regli-vonungern@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary