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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000429550
Ethics application status
Approved
Date submitted
28/09/2006
Date registered
4/10/2006
Date last updated
4/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised comparison of the Ambu® Laryngeal Mask with the Laryngeal Mask Airway UniqueTM during anaesthesia in spontaneously breathing adult patients
Scientific title
A single-blind randomised phase IV study to evaluate the effectiveness of the AMBU Aura-once disposable Laryngeal Mask against the Laryngeal Mask Airway -unique wih respect to sealing pressure and ease of use for airway maintenance during spontaneous ventilation general anaesthesia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway maintenance during anaesthesia 1401 0
Condition category
Condition code
Anaesthesiology 1493 1493 0 0
Other anaesthesiology
Respiratory 1494 1494 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AMBU laryngeal mask over the course of a single general anaesthetic procedure and 24 hrs post-operatively
Laryngeal Mask Airway - Unique over the course of a single general anaesthetic procedure and 24 hrs post-operatively
Intervention code [1] 1381 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2064 0
Airway leakage pressure
Timepoint [1] 2064 0
Measured just post device insertion
Secondary outcome [1] 3555 0
Time for insertion of device
Timepoint [1] 3555 0
As device is inserted
Secondary outcome [2] 3556 0
Adequacy of airway post insertion
Timepoint [2] 3556 0
Throughout the surgical procedure
Secondary outcome [3] 3557 0
Post operative sore throat
Timepoint [3] 3557 0
Immediately post surgery, 24 hrs post surgery

Eligibility
Key inclusion criteria
Adults who are undergoing general anaesthesia suitable for a LMA.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recognised non suitability for supraglottic airway usage.

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)
Unaware of timing and group due to allocation being involved contacting the holder of the allocation schedule who was “off-site” or at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patient is blinded to the intervention
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 1631 0
Hospital
Name [1] 1631 0
Royal Melbourne hospital
Address [1] 1631 0
Country [1] 1631 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital - Department of Anaesthesia and Pain Management
Address
Country
Australia
Secondary sponsor category [1] 1434 0
None
Name [1] 1434 0
Nil
Address [1] 1434 0
Country [1] 1434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3077 0
Melbourne Health-Royal Melbourne Hospital
Ethics committee address [1] 3077 0
Ethics committee country [1] 3077 0
Australia
Date submitted for ethics approval [1] 3077 0
Approval date [1] 3077 0
13/09/2006
Ethics approval number [1] 3077 0
2006.173

Summary
Brief summary
Randomised trial of two supraglottic airway devices by measuring objective outcomes in spontaneously breathing adult patients. Our hypothesis is that there will be no identifiable difference (null hypothesis).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27608 0
Address 27608 0
Country 27608 0
Phone 27608 0
Fax 27608 0
Email 27608 0
Contact person for public queries
Name 10570 0
Dr. Karl Alexander
Address 10570 0
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 10570 0
Australia
Phone 10570 0
+61 3 93427540
Fax 10570 0
Email 10570 0
karl.alexander@mh.org.au
Contact person for scientific queries
Name 1498 0
Dr David Andrews
Address 1498 0
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 1498 0
Australia
Phone 1498 0
+61 3 93427540
Fax 1498 0
Email 1498 0
david.andrews@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results