Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000365965
Ethics application status
Not yet submitted
Date submitted
7/04/2011
Date registered
8/04/2011
Date last updated
8/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Placement of LMA Supreme versus GuardianCPV – a randomized controlled trial assessing leak pressure, cuff pressure and fibreoptic grading of airway placement.
Scientific title
In adult surgical patients, comparing LMA Supreme with GuardianCPV with respect to leak pressure, cuff pressure and fibreoptic grading of airway placement.
Secondary ID [1] 259955 0
from the Princess Alexandra Hospital Research Ethics Committee HREC/11/QPAH/73
Universal Trial Number (UTN)
Trial acronym
PLSG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngeal mask airway placement during surgery. 265583 0
Condition category
Condition code
Anaesthesiology 265728 265728 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laryngeal Mask Airways (LMAs) are airway devices that are placed in the pharynx for the duration of an anaesthetic.
The duration of anaesthetic differs on a case by case basis, as demanded by the surgical procedure. This is a one-off treatment for a specified surgical procedure.
The research project aims to compare 2 different LMA devices – one of which we use on a daily basis (the LMA Supreme), and the other is a newly released LMA (the GuardianCPV) which claims certain benefits.
The guardianCPV claims to have a higher seal pressure.
Intervention code [1] 264366 0
Treatment: Devices
Comparator / control treatment
Guardian CVP versus LMA Supreme (standard treatment)
Control group
Active

Outcomes
Primary outcome [1] 266487 0
Cuff pressure - the air pressure in the cuff of the airway device, measured by connecting a manometer to the cuff inflation valve.
Timepoint [1] 266487 0
at the time of LMA placement
Primary outcome [2] 266488 0
the seal pressure - the pressure in the lungs at which air begins to leak around the edges of the LMA, measured by occluding the airway valve, allowing airway pressures to slowly rise, and noting the pressure at which air leak is heard around the airway device
Timepoint [2] 266488 0
at the time of LMA placement
Primary outcome [3] 266489 0
the fibreoptic grading - an assessment of how well the LMA is placed, gained from visual inspection of the larynx through the LMA using a camera. An image of the larynx will be recorded and later graded according to an established fibreoptic grading system.
Timepoint [3] 266489 0
at the time of LMA placement
Secondary outcome [1] 273885 0
nil
Timepoint [1] 273885 0
nil

Eligibility
Key inclusion criteria
Adult patients undergoing elective surgery with an LMA
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients requiring intubation
Women who are pregnant and the human foetus
Children and/or young people (ie. <18 years)
People in existing dependent or unequal relationships
People highly dependent on medical care
People with a cognitive impairment, an intellectual disability or a mental illness
People who may be involved in illegal activity

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)
Patients who are likely to require an LMA during their upcoming surgery at the Princess Alexandra Hospital will be approached in the Pre-admission clinic, well prior to surgery, and asked it they would like to participate in this research project.
The type of LMA to be selected, shall be drawn from sealed envelopes by the Anaesthetic Nurse assisting the Anaesthetist, and handed over to the Anaesthetist at time of intubation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The type of LMA to be selected, shall be drawn from sealed envelopes by the Anaesthetic Nurse assisting the Anaesthetist, and handed over to the Anaesthetist at time of intubation.
The random order for allocation of subjects will be via simple randomisation using a coin-toss.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264841 0
Self funded/Unfunded
Name [1] 264841 0
Country [1] 264841 0
Primary sponsor type
Hospital
Name
The Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 263941 0
None
Name [1] 263941 0
Address [1] 263941 0
Country [1] 263941 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266807 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 266807 0
Human Research Ethics Committee Princess Alexandra Hospital
Wooloongabba, QLD. 4102.
Ethics committee country [1] 266807 0
Australia
Date submitted for ethics approval [1] 266807 0
07/04/2011
Approval date [1] 266807 0
Ethics approval number [1] 266807 0
HREC/11/QPAH/73

Summary
Brief summary
The research project aims to compare 2 different Laryngeal Mask Airways, and to establish which is superior of the two.

The main interest of our trial is to determine which LMA is easier to insert properly, and how well they both maintain a good seal.

To date we have seen that there is occasionally some difficulty in placing the LMA, with consequent suboptimal airway control. Device manufacturers are always presenting us with new and improved versions of these devices, and we feel that it is the place of research projects such as this to help us decide if the new devices are worth employing. This sort of research may also aid in the development of future airway devices, leading to safer delivery of anaesthesia to the community.

80 patients will be enrolled in this project which will only be run at the Princess Alexandra Hospital. All patients enrolled in this project will have either one of these “LMAs” inserted after the anaesthetic has started. We will only be trialing 2 types of “LMA”, namely the LMA Supreme and the GuardianCPV, as previously mentioned.

All the researchers involved will be from the Princess Alexandra Hospital. This research will be used by the principal researcher Dr Colin Brodie (currently in training in the specialty of anaesthesia) as part of a requirement of his training to become a specialist anaesthetist. This project is not funded by any sponsorship or grant, and all funding for this project will come from the Anaesthetic Department at the Princess Alexandra Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32257 0
Address 32257 0
Country 32257 0
Phone 32257 0
Fax 32257 0
Email 32257 0
Contact person for public queries
Name 15504 0
Colin Brodie
Address 15504 0
Anaesthetic Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 15504 0
Australia
Phone 15504 0
+61 7 3176 2822
Fax 15504 0
+61 7 3176 5102
Email 15504 0
[email protected]
Contact person for scientific queries
Name 6432 0
Colin Brodie
Address 6432 0
Anaesthetic Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 6432 0
Australia
Phone 6432 0
+61 7 3176 2822
Fax 6432 0
+61 7 3176 5102
Email 6432 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.