Trial Review

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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
Scientific title
Evaluation of the Guardian CPV(TM) Laryngeal Mask during Anaesthesia for General Surgery
Secondary ID [1] 273337 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

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 0
Condition category
Condition code
Anaesthesiology 270586 270586 0 0
Anaesthetics
Surgery 279294 279294 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 267078 0
Treatment: Devices
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269328 0
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.
Timepoint [1] 269328 0
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
Secondary outcome [1] 279386 0
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
Timepoint [1] 279386 0
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.
Secondary outcome [2] 279387 0
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)
Timepoint [2] 279387 0
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)
Secondary outcome [3] 279388 0
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?
Timepoint [3] 279388 0
This outcome is assessed during anaesthesia delivery once mechanical ventilation has been commenced.

Eligibility
Key inclusion criteria
Al patients suitable for laryngeal mask anaesthesia undergoing general surgical procedures under anaesthesia care from the nominated investigators
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Device determined to be clinically satisfactory. No unresolved problems to assess. Administrative details as above determined that insufficient
Date of first participant enrolment
Anticipated
13/06/2011
Actual
13/06/2011
Date of last participant enrolment
Anticipated
Actual
22/12/2011
Date of last data collection
Anticipated
22/12/2011
Actual
22/12/2011
Sample size
Target
100
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14170 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 27147 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 267547 0
Commercial sector/Industry
Name [1] 267547 0
Anaequip
Country [1] 267547 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
South Australia
5000
Country
Australia
Secondary sponsor category [1] 266586 0
None
Name [1] 266586 0
Address [1] 266586 0
Country [1] 266586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269510 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 269510 0
Level 3, Hanson Institute
c/o
Royal Adelaide Hospital
North Terrace Adelaide
SA
5000
Ethics committee country [1] 269510 0
Australia
Date submitted for ethics approval [1] 269510 0
Approval date [1] 269510 0
04/05/2011
Ethics approval number [1] 269510 0
RAH PROTOCOL No. 110214

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)
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 32947 0
Dr Edward Murphy
Address 32947 0
c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
Country 32947 0
Australia
Phone 32947 0
+61 8 7074 0000
Fax 32947 0
Email 32947 0
[email protected]
Contact person for public queries
Name 16194 0
Dr Dr Edward Murphy
Address 16194 0
c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
Country 16194 0
Australia
Phone 16194 0
+61 8 7074 0000
Fax 16194 0
n/a
Email 16194 0
[email protected]
Contact person for scientific queries
Name 7122 0
Dr Dr Edward Murphy
Address 7122 0
c/o Department of Anaesthesia,
Royal Adelaide Hospital,
Port Road,
Adelaide
5000
SA
Country 7122 0
Australia
Phone 7122 0
+61 8 7074 0000
Fax 7122 0
n/a
Email 7122 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study results not available for public distribution. Consent issues (see recruitment section)


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.