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Trial registered on ANZCTR


Registration number
ACTRN12615000783527
Ethics application status
Approved
Date submitted
9/07/2015
Date registered
28/07/2015
Date last updated
1/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the new laryngeal mask airway (LMA), LMA-Protector with the LMA-Supreme in surgical patients requiring airway management with an LMA.
Scientific title
Comparison of the LMA-Protector versus the LMA-Supreme on correct fit and positioning in surgical patients requiring LMA airway management.
Secondary ID [1] 287059 0
Nil
Universal Trial Number (UTN)
U1111-1172-0054
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 295551 0
Oropharyngeal leak pressure 295552 0
Downfolding of epiglottis 295553 0
Condition category
Condition code
Anaesthesiology 295823 295823 0 0
Anaesthetics
Surgery 295951 295951 0 0
Other surgery
Public Health 295952 295952 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LMA-Protector is a new single-use, silicone, TGA- approved device that has similar features to other LMAs made of PVC. The silicone composition of the LMA-Protector makes it very flexible and the device allows access to and functional separation of the ventilation and digestive tracts with 2 drainage channels. Its use involves insertion under anaesthesia and inflation of the cuff once correct position in the hypopharynx is achieved. Duration of use is from the start of general anaesthesia to the end of the surgical procedure, and total time is dependent on the surgical procedure. The anaesthetist will administer the intervention and record a log of use time.
Intervention code [1] 292291 0
Treatment: Devices
Comparator / control treatment
Standard treatment is the single-use LMA device, the LMA-Supreme made of PVC with a drain tube to separate the ventilation and digestive tracts and a strong inner cuff to prevent airway obstruction. Use of both the LMA- Protector and the control LMA-Supreme involves insertion under anaesthesia and inflation of the cuff once correct position in the hypopharynx is achieved. Duration of use for each device is from the start of general anaesthesia to the end of the surgical procedure, with total time dependent on the surgical procedure. The anaesthetist will administer the intervention or the control treatment and record a log of use time.
Control group
Active

Outcomes
Primary outcome [1] 295516 0
Oropharyngeal leak pressure assessed by detection of audible noise by neck stethoscopy.
Timepoint [1] 295516 0
On device insertion.
Secondary outcome [1] 315742 0
Anatomical position of the device in the hypopharynx is assessed by the anaesthetist.
Timepoint [1] 315742 0
On device insertion.
Secondary outcome [2] 315743 0
Whether the correct size of the device is used as assessed by the anaesthetist.
Timepoint [2] 315743 0
On device insertion.
Secondary outcome [3] 315744 0
Whether the epiglottis is downfolded, as assessed by the anaesthetist.
Timepoint [3] 315744 0
On device insertion.
Secondary outcome [4] 315745 0
Manoeuvers needed to adjust malplacement as assessed by the anaesthetist.
Timepoint [4] 315745 0
On device insertion.

Eligibility
Key inclusion criteria
American Society of Anesthesiology physical status grade 1-3 and scheduled elective surgery under general anaesthesia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant, at risk of aspiration of gastric contents, requiring surgery in a position other than supine, undergoing head and neck surgery, or need endotracheal intubation.

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)
Randomised controlled single-blinded trial. Allocation concealment performed by contacting the holder of the allocation schedule on computer at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was created using Stata software for the 2-treatment study, and saved as a Microsoft Excel file. Using 2 block sizes, the block identity number (blockid), number of patients in each block (blocksize) and each recruited patient’s sequence within their block (SeqInBlk) are recorded. Two treatment arms are labelled “protector” or “supreme”. Patients are allocated in the ratio 1:1 to these two treatments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical power of the oropharyngeal leak test was evaluated on a continuous scale at which each patient’s oropharyngeal leak was detected, as modelled from a meta-analysis in this subject area published by Maitra et al in 2014. This study provided data to allow assumption that the oropharyngeal leak pressure within each subject group would be normally distributed with standard deviation 5 cm H2O. Based on this data, the participant number of 100 was selected. With 50 interventional participants and 50 controls, this provides comparison with a probability (power) of 80% to detect this difference, with a 2-tailed type I error of 0.05. Analysis of the difference between the means and descriptive analyses of demographic data and risk factors will be performed. Risk difference and risk ratio of the two groups will be calculated. Intention to treat methodology will be followed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2015
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
23/06/2016
Date of last data collection
Anticipated
Actual
23/06/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4022 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 9944 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 291619 0
Self funded/Unfunded
Name [1] 291619 0
Country [1] 291619 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 290292 0
University
Name [1] 290292 0
University of Queensland
Address [1] 290292 0
St Lucia Qld 4072
Country [1] 290292 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293151 0
Royal Brisbane & Women's Hospital Human Reseaerch Ethics Committee
Ethics committee address [1] 293151 0
Ethics committee country [1] 293151 0
Australia
Date submitted for ethics approval [1] 293151 0
Approval date [1] 293151 0
15/06/2015
Ethics approval number [1] 293151 0
HREC/15/QRBW/248

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58674 0
Prof Andre van Zundert
Address 58674 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia, Butterfield Street, Herston. QLD 4029
Country 58674 0
Australia
Phone 58674 0
+617 36465673
Fax 58674 0
+617 36461308
Email 58674 0
[email protected]
Contact person for public queries
Name 58675 0
Heather Reynolds
Address 58675 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia and Perioperative Medicine, Butterfield Street, Herston. QLD 4029
Country 58675 0
Australia
Phone 58675 0
+617 36465453
Fax 58675 0
+617 36461308
Email 58675 0
[email protected]
Contact person for scientific queries
Name 58676 0
Andre van Zundert
Address 58676 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia and Perioperative Medicine, Butterfield Street, Herston. QLD 4029
Country 58676 0
Australia
Phone 58676 0
+617 36465673
Fax 58676 0
+617 36461308
Email 58676 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
SourceTitleYear of PublicationDOI
EmbaseA prospective randomized comparison of airway seal using the novel vision-guided insertion of LMA-Supreme and LMA-Protector.2020https://dx.doi.org/10.1007/s10877-019-00301-3
N.B. These documents automatically identified may not have been verified by the study sponsor.