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Trial registered on ANZCTR
Registration number
ACTRN12612000330842
Ethics application status
Approved
Date submitted
16/10/2011
Date registered
22/03/2012
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the Guardian CPV(TM) Laryngeal Mask during Anaesthesia for General Surgery
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Scientific title
Evaluation of the Guardian CPV(TM) Laryngeal Mask during Anaesthesia for General Surgery
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Secondary ID [1]
273337
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Assessing suitability of a new laryngeal mask airway for use in general surgical patients under anaesthesia at the Royal Adelaide Hospital
270440
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Condition category
Condition code
Anaesthesiology
270586
270586
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0
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Anaesthetics
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Surgery
279294
279294
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Use of the Guardian CPV (TM) Laryngeal Mask for airway management under anaesthesia:
The TGA approved Guardian CPV (TM) Laryngeal mask is inserted into the patients upper airway via the mouth, to provide a breathing pathway under anaesthesia for various types of surgery. It is used in place of various competitor products which are also TGA approved and used for many standard anaesthesia procedures. According to the study protocol, the device would be used for surgical procedures which are unlikely to exceed 2 hours duration
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Intervention code [1]
267078
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Treatment: Devices
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Comparator / control treatment
Not Applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Confirm suitability of device for TGA registered purpose in the study institution:
Assessment occurs during routine anaesthesia practice where an LMA is inserted by an anaesthesia specialist or registrar to facilitate airway management. Assessment is via a questionnaire for the attending anaesthetist which asks whether manufacturers instructions resulted in a clear airway without leaks, and other minor indicators of ease of use.
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Assessment method [1]
269328
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Timepoint [1]
269328
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The assessment occurs during use of the device (over a time period unlikely to exceed 2 hours of use during anaesthesia for a surgical procedure
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Secondary outcome [1]
279386
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The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges
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Assessment method [1]
279386
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Timepoint [1]
279386
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This outcome is assessed at a single timepoint during use, as above. Basic statistical analysis will be used at the end of the study to determine agreement between claimed and measured values.
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Secondary outcome [2]
279387
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Determine increase in cuff pressure if there has been use of nitrous oxide for a minimum duration of 30 minutes.
Assessment occurs by:
1) Measurement of pressure using the standard cuff pressure gauge, after equilibration with nitrous oxide has occurred (after LMA insertion and at least 30 minutes use of nitrous oxide)
2) Removal of volume from the cuff until pressure returns to the original reading (the volume to achieve this is recorded)
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Assessment method [2]
279387
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Timepoint [2]
279387
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This outcome is assessed at two timepoints during anaesthesia delivery:
1) when the initial pressure measurement occurs after insertion and inflation.
2) when at least 30 minutes of nitrous oxide anaesthesia has been sustained (cuff pressure changes occur because nitrous oxide diffuses across the cuff membrane and is expected to be in equilibrium after 30 minutes)
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Secondary outcome [3]
279388
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To determine if the device functions satisfactorily for controlled ventilation and at what pressures.
Assessment is via the anaesthetist questionnaire which asks:
1) if mechanical ventilation was used, then was it achievable using the LMA, and what peak airway pressure was used (if not achievable using an LMA, then standard anaesthesia practise is to change to an endotracheal airway)
2) what range was the intrinsic cuff pressure indicator reading when mechanical ventilation was satisfactorily in use, and what pressure did the standard analogue pressure gauge indicate?
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Assessment method [3]
279388
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Timepoint [3]
279388
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This outcome is assessed during anaesthesia delivery once mechanical ventilation has been commenced.
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Eligibility
Key inclusion criteria
Al patients suitable for laryngeal mask anaesthesia undergoing general surgical procedures under anaesthesia care from the nominated investigators
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Age less than 18 years (LMA use is not age limited in standard anaesthesia practice).
Body Mass Index (BMI) of <18 or > 35 kg/m2.
Inability to communicate well with the study staff or comply with the study requirements and restrictions.
Inability to understand the Study Information Sheet and provide a written consent to take part in the study.
Poor understanding of the procedure.
Poor command of the English Language.
An anaesthesia procedure which is unlikely to extend beyond 2 hours.
Uncontrolled gastro-oesophageal reflux or regurgitation.
High risk for aspiration of gastric contents into lungs.
Previous difficulty with insertion of an LMA.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Given that the trial aims to assess suitability for all patient groups over 18 years old within a specified normal body mass index range who are suitable for a Laryngeal Mask Airway (LMA), the intention is that all eligible patients will be given the opportunity to participate. Patient enrolment will be at the discretion of the anaesthetist but may occur during a standard preoperative assessment interview
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Device determined to be clinically satisfactory. No unresolved problems to assess. Administrative details as above determined that insufficient
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Date of first participant enrolment
Anticipated
13/06/2011
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Actual
13/06/2011
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Date of last participant enrolment
Anticipated
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Actual
22/12/2011
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Date of last data collection
Anticipated
22/12/2011
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Actual
22/12/2011
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Sample size
Target
100
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
14170
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
27147
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
267547
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Commercial sector/Industry
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Name [1]
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Anaequip
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Address [1]
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Anaequip Medical
U6, 28 Heath Street
LONSDALE SA 5160
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Country [1]
267547
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital
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Address
North Terrace
Adelaide
South Australia
5000
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Country
Australia
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Secondary sponsor category [1]
266586
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None
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Name [1]
266586
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Address [1]
266586
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Country [1]
266586
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269510
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Royal Adelaide Hospital Research Ethics Committee
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Ethics committee address [1]
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Level 3, Hanson Institute c/o Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Ethics committee country [1]
269510
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Australia
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Date submitted for ethics approval [1]
269510
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Approval date [1]
269510
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04/05/2011
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Ethics approval number [1]
269510
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RAH PROTOCOL No. 110214
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Summary
Brief summary
The main purpose of this study is to determine if claimed improvements in a new version of a common medical device are reasonable and if it is appropriate to use these devices instead of the current devices in use (at the Royal Adelaide Hospital)
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Trial website
n/a
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Trial related presentations / publications
n/a
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Public notes
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Contacts
Principal investigator
Name
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Dr Edward Murphy
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Address
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c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
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Country
32947
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Australia
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Phone
32947
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+61 8 7074 0000
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Fax
32947
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Email
32947
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[email protected]
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Contact person for public queries
Name
16194
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Dr Edward Murphy
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Address
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c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
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Country
16194
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Australia
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Phone
16194
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+61 8 7074 0000
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Fax
16194
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n/a
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Email
16194
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[email protected]
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Contact person for scientific queries
Name
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Dr Edward Murphy
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Address
7122
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c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
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Country
7122
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Australia
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Phone
7122
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+61 8 7074 0000
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Fax
7122
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n/a
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Email
7122
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Study results not available for public distribution. Consent issues (see recruitment section)
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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.
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