Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000559213
Ethics application status
Approved
Date submitted
7/04/2018
Date registered
13/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Red plunger syringes for muscle relaxant drug safety: brilliant or bothersome? A survey of anaesthetists and anaesthetic trainees in Australia and New Zealand, and review of incident report data involving muscle relaxant drug errors
Scientific title
Red plunger syringes for muscle relaxant drug safety: A cross-sectional survey of anaesthetists and anaesthetic trainees in Australia and New Zealand and analysis of de-identified incidents reported to WebAIRS
Secondary ID [1] 294528 0
Nil known
Universal Trial Number (UTN)
U1111-1212-0262
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic drug errors involving muscle relaxants 307301 0
Condition category
Condition code
Anaesthesiology 306416 306416 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The red plunger syringe is an Australian safety initiative introduced in the mid 1990s to reduce the number of drug errors involving muscle relaxants in anaesthesia. To our knowledge, its impact has not previously been formally evaluated.

We will be undertaking a survey of stratified, randomly selected anaesthetists and anaesthetic trainees in Australia and New Zealand to assess their opinions on how successful the red syringe has been as a drug safety initiative, determine how widely it has been adopted, and to establish if it can be modified to better meet anaesthetists' needs in providing safe care to the community.

The survey will be distributed by email to randomly selected members of the Australian and New Zealand College of Anaesthetists (ANZCA) through the ANZCA Clinical Trials Network (CTN). The breakdown of survey participants will be stratified to include enough fellows and trainees from both Australia and New Zealand, as well as International Medical Graduate Specialists (IMGS), to make meaningful comparisons between groups.

Participants will have an option to complete the survey online, or to print the survey, hand-write the answers and return it via reply-paid post. Participants who have not completed the survey within 28 days, and have not specified that they do not wish to participate, will be sent a reminder email by ANZCA. Responses will be collected up to two months after the first invitation was sent and will be collated using Qualtrics software.

We intend to also distribute the survey to a random sample of GP (General Practitioner) Anaesthetists and trainees in Australia. The details of distribution for this group have not yet been finalised.

In the interest of maintaining the participant privacy, the email addresses of participants will be known to the ANZCA CTN, but not to the investigators.

We will also perform a retrospective analysis of all drug errors involving muscle relaxants that have ever been reported to the WebAIRS (web-­based anaesthetic incident recording system) in Australia and New Zealand. The purpose of this is to determine if and how the red plunger syringe was used in each case. Access to this data is being supported by the Australian and New Zealand Tripartite Anaesthetic Data Committee (ANZTADC).
Intervention code [1] 300828 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305430 0
To determine whether anaesthetists and trainees choose/choose not to use red plunger syringes when available to them, and the rationale underpinning these choices.
Timepoint [1] 305430 0
2 months after initial survey distribution
Secondary outcome [1] 345209 0
To determine whether red plunger syringes are consistently available to anaesthetists and trainees in Australia and New Zealand.
Timepoint [1] 345209 0
2 months after initial survey distribution
Secondary outcome [2] 345210 0
To determine if there is a difference in demographics between users and non-users of the red plunger syringe that may help explain uptake.
Timepoint [2] 345210 0
2 months after initial survey distribution
Secondary outcome [3] 345211 0
To determine whether modifications can be made to the design of the red plunger syringe to better meet anaesthetists’ needs in providing safe anaesthetic care to the community.
Timepoint [3] 345211 0
2 months after initial survey distribution
Secondary outcome [4] 345212 0
To determine if and how red plunger syringes were used in cases of muscle relaxant drug errors reported to WebAIRS since its inception
Timepoint [4] 345212 0
30 September 2018

Eligibility
Key inclusion criteria
Participants must hold a primary medical degree and be fellows or trainees of ANZCA. We also seek to include IMGS who have qualified as anaesthetists overseas and undertaking a program of study or clinical practice in Australia or New Zealand to obtain ANZCA Fellowship.

We also intend to survey GP anaesthetists and trainees undergoing anaesthesia training through the Royal Australian College of General Practitioners and/or the Australian College of Rural and Remote Medicine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We seek to capture the experiences of anaesthetists and trainees across Australia and New Zealand who are likely to use muscle relaxants on a regular basis.

We will therefore exclude ANZCA fellows and trainees currently working entirely in countries other than Australia and New Zealand (to whom the red plunger syringe will not be available), as well as fellows and trainees not in current practice. Fellows of the Faculty of Pain Medicine of ANZCA who do not work in anaesthesia (to which the majority of questions will not be applicable) will also be excluded.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
Firstly, demographics will be tabulated to create the description of the survey respondents. This step will also assist in determining the requirement for weighting of the results to ensure generalisability.

Secondly, all quantitative question responses will be summarised to assess study objectives: the availability, requirements for its application in different settings, and usage of the red plunger syringe. As well, how fellows and trainees choose to use the red plunger, how they value it, and if they recommend design modifications to facilitate improved usage will be summarised and reviewed. This univariate analysis will entail primarily proportional distributions of categorical responses and likert-scale type agreement questions.

Thirdly, qualitative (open-ended) responses will be reviewed, coded and summarised to support the description of qualitative findings and conclusions where indicated. WebAIRS data from reported incidents will also be analysed qualitatively by coding.

Fourthly, statistical testing will be conducted to support or refute the study objectives using Z- test statistics and Pearson Chi square analysis or Fisher Exact tests if needed. Z-tests will be used to test for statistically significant differences in proportions for nominal categorical questions (Yes / No) and Chi square tests for correlations on the agreement-scale questions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2018
Actual
22/05/2018
Date of last participant enrolment
Anticipated
14/07/2018
Actual
4/06/2018
Date of last data collection
Anticipated
30/09/2018
Actual
4/07/2018
Sample size
Target
1254
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 10259 0
New Zealand
State/province [1] 10259 0
All

Funding & Sponsors
Funding source category [1] 299155 0
Self funded/Unfunded
Name [1] 299155 0
Dr Dash Newington
Country [1] 299155 0
Australia
Primary sponsor type
Individual
Name
Dr Dash Newington
Address
Paediatric Intensive Care Unit
Queensland Children's Hospital
501 Stanley Street
South Brisbane
QLD 4101
Australia
Country
Australia
Secondary sponsor category [1] 298411 0
University
Name [1] 298411 0
Imperial College London
Address [1] 298411 0
Department of Surgery and Cancer
Imperial College London
Praed St
London
W2 1NY
Country [1] 298411 0
United Kingdom
Secondary sponsor category [2] 298413 0
Other Collaborative groups
Name [2] 298413 0
Australian and New Zealand College of Anaesthetists Clinical Trials Network
Address [2] 298413 0
ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia.
Country [2] 298413 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300080 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 300080 0
Ethics committee country [1] 300080 0
Australia
Date submitted for ethics approval [1] 300080 0
04/03/2018
Approval date [1] 300080 0
27/03/2018
Ethics approval number [1] 300080 0
HREC/18/QRBW/131
Ethics committee name [2] 300081 0
Nelson Marlborough District Health Board
Ethics committee address [2] 300081 0
Ethics committee country [2] 300081 0
New Zealand
Date submitted for ethics approval [2] 300081 0
21/12/2017
Approval date [2] 300081 0
17/01/2018
Ethics approval number [2] 300081 0
N/A
Ethics committee name [3] 300082 0
Imperial College Research Ethics Committee
Ethics committee address [3] 300082 0
Ethics committee country [3] 300082 0
United Kingdom
Date submitted for ethics approval [3] 300082 0
06/03/2018
Approval date [3] 300082 0
06/04/2018
Ethics approval number [3] 300082 0
18IC4453

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

Contacts
Principal investigator
Name 82506 0
Dr Dash Newington
Address 82506 0
Paediatric Intensive Care Unit
Queensland Children's Hospital
501 Stanley St
South Brisbane
QLD 4101
Australia
Country 82506 0
Australia
Phone 82506 0
+61 424423377
Fax 82506 0
Email 82506 0
dash.newington@student.unimelb.edu.au
Contact person for public queries
Name 82507 0
Dash Newington
Address 82507 0
Department of Anaesthesia
Royal Brisbane & Women's Hospital
Cnr Bowen Bridge Rd & Butterfield St
Herston, Queensland, 4029
Country 82507 0
Australia
Phone 82507 0
+61 424423377
Fax 82507 0
Email 82507 0
dash.newington@student.unimelb.edu.au
Contact person for scientific queries
Name 82508 0
Dash Newington
Address 82508 0
Department of Anaesthesia
Royal Brisbane & Women's Hospital
Cnr Bowen Bridge Rd & Butterfield St
Herston, Queensland, 4029
Country 82508 0
Australia
Phone 82508 0
+61 424423377
Fax 82508 0
Email 82508 0
dash.newington@student.unimelb.edu.au

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
No additional documents have been identified.