Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000586213
Ethics application status
Approved
Date submitted
4/03/2009
Date registered
15/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the effectiveness of 4 disposable supraglottic airway devices and one reusable ‘Laryngeal Mask Airway (LMA) classic’ for use in flexible bronchoscopy in children.
Scientific title
Comparison of the effectiveness (in terms of ease of manipulation of the scope and resistance encountered) of 4 disposable supraglottic airway devices and one reusable ‘Laryngeal Mask Airway (LMA) classic’ for use in flexible bronchoscopy in children with acute and chronic lung disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bronchiectasis 237224 0
recurrent cough 237225 0
recurrent lower respiratory tract infection 237226 0
Condition category
Condition code
Respiratory 4681 4681 0 0
Other respiratory disorders / diseases
Surgery 239545 239545 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 Disposable LMAs : Unique (Polyvinyl Chloride (PVC) construction) similar in form to the LMA Classic, Portex soft seal(PVC construction also similar form to the LMA Classic), Ambu Aura Once (green preformed curve PVC construction with an inflateable cuff similar to the LMA CLassic), Boss systems (disposable silicone construction very sinilar in construction to the LMA CLassic) are compared to the Classic LMA (high grade medical silicone construction) in an randomised clinical trial in children below the weight of 50Kg. Each child is randomised to one of the disposable LMAs, which is inserted into the airway under general anesthesia for a duration of approximately 10minutes and a flexible bronchscopy is performed via the LMA. The LMA Classic is inserted in the same patient either preceding or following the disposable LMA (during the same general anaesthetic) depending on randomisation order. Bronchoscopy is performed via the LMA Classic also for a duration of approximately 10 minutes. Observations are made throughout both processes and the final LMA removed prior to recovery from general anesthesia.
Intervention code [1] 4159 0
Treatment: Surgery
Comparator / control treatment
The LMA company 'Classic LMA' is a medical grade silicone contructed supraglottic airway inserted into the mouth and resting above the larynx in the supraglottic space. It is used for maintaining a clear airway during general anaesthesia. Thois particular design is considered a gold standard for supraglottic airway devices due to the number of safety and efficacy trials in the literature. The Classic LMA is inserted for half of the time required to complete the flexible bronchscopy study (generally 10 minutes)
Control group
Active

Outcomes
Primary outcome [1] 5544 0
difference between each disposable LMA and the Classic LMA with regard to resistance encountered to scope manipulation 1. in the LMA 2. at the vocal cords 3. below the vocal cords 4. overall impression of ease of use. These are all subjectively scored on a 10cm line by the bronchoscopist.
Timepoint [1] 5544 0
immediately following attempted bronchoscopy with each Laryngeal mask
Secondary outcome [1] 9339 0
cuff pressures when inflated within manufacturers guidelines
Timepoint [1] 9339 0
pressures are measured with a pressure manometer immediately following inflation of the laryngeal mask cuff and pressure reduced immediately to 20cmH2O
Secondary outcome [2] 9340 0
cuff volumes measured using a syringe to extract the air in the cuff following removal of the laryngeal mask from the child's airway (cuff pressure while in te airway was standardised at 20cmH2O
Timepoint [2] 9340 0
immediately following removal of laryngeal mask
Secondary outcome [3] 9341 0
leak pressures with cuff inflated to 20cm water are measured by increasing the pressure release valve for the anaesthetic cicuit to 30cmH2O and observing the highest pressure obtained in the circuit (determined by the pressure at which the air leaks aound the laryngeal mask and out of the child's mouth
Timepoint [3] 9341 0
immediately apon measuring the leak pressure during the general anaesthetic

Eligibility
Key inclusion criteria
all children presenting for flexible bronchoscopy at Starship Children's Health between March 2008 and April 2009 or until 100 patients are recruited
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
weight >50kg
children with previous difficult bronchoscopy
children deemed too unwell to use an LMA or change an LMA during the procedure
patient or caregiver or physician refusal
allergy to any material used for the study
family or child refusal

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 by computer generated programme to one of the 4 disposable LMAs and every child received the Classic LMA. The order in which the 2 LMAs are inserted is also randomised. The respiratory physician who enrolled their patient in the study was unaware of the randomisation result. The anaesthetist performing the anaesthetic was aware of the randomisation result only after the patient was enrolled. The holder of the randomisation schedule was on-site (although outside the clinical area) approximately 50% of the time and off site the other 50%. Contact was made to obtain randomisation details only following enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation programme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1608 0
New Zealand
State/province [1] 1608 0

Funding & Sponsors
Funding source category [1] 4604 0
Hospital
Name [1] 4604 0
Auckland Hospital Anaesthetic Department Research Fund
Country [1] 4604 0
New Zealand
Funding source category [2] 237317 0
Hospital
Name [2] 237317 0
Auckland Hospital
Country [2] 237317 0
New Zealand
Primary sponsor type
Individual
Name
Katharine Brunette (Young)
Address
PO Box 28478 Remuera Auckland 1541
Country
New Zealand
Secondary sponsor category [1] 4153 0
Individual
Name [1] 4153 0
Paul Baker
Address [1] 4153 0
PO Box 28478 Remuera Auckland 1541
Country [1] 4153 0
New Zealand
Other collaborator category [1] 601 0
Individual
Name [1] 601 0
Catherine Byrnes
Address [1] 601 0
PO Box 28478 Remuera Auckland 1541
Country [1] 601 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6649 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6649 0
PO Box 1031 Hamilton 3240
Ethics committee country [1] 6649 0
New Zealand
Date submitted for ethics approval [1] 6649 0
Approval date [1] 6649 0
29/02/2008
Ethics approval number [1] 6649 0
NYT/07/12/134

Summary
Brief summary
Laryngeal masks (LMAs) are ideally suited to support flexible bronchoscopic examination and lavage of the airways. Recently at Starship Children’s Health, concerns arose with a move from reusable LMAs, which have potential infective risks, to a disposable version. Increased resistance to the bronchoscope increases the difficulty and duration of the procedure. This can necessitate additional lubrication and/or the use of scissors to modify the mask- neither measure is ideal. Our goal is to compare available disposable LMA devices (LMA unique, Portex Soft Seal, Boss , AMBU) with the reusable ‘classic LMA’ for efficiency and effectiveness in the paediatric flexible bronchoscopy service. Our bench testing of various LMAs in mannequins allowed selection of those most appropriate to assess in clinical practice. Caregivers of the children on the fortnightly bronchoscopy list will be invited to take part. Children will be randomised to 1 of the disposable devices, and the reusable LMA. The respiratory paediatrician will grade each device for resistance to scope manipulation, laryngeal view and overall ease of use. A formal prospective study would be helpful to assist our own, national and international decision making as recommendations move towards using disposable items where possible. No company is sponsoring this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29349 0
Address 29349 0
Country 29349 0
Phone 29349 0
Fax 29349 0
Email 29349 0
Contact person for public queries
Name 12596 0
Katharine Brunette
Address 12596 0
PO Box 28478 Remuera Auckland 1541
Country 12596 0
New Zealand
Phone 12596 0
+64 9 376 0000
Fax 12596 0
Email 12596 0
[email protected]
Contact person for scientific queries
Name 3524 0
Katharine Brunette
Address 3524 0
PO Box 28478 Remuera Auckland 1541
Country 3524 0
New Zealand
Phone 3524 0
+6421309315
Fax 3524 0
Email 3524 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
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