Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000681651
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
26/06/2023
Date last updated
26/06/2023
Date data sharing statement initially provided
26/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring use of inhalational anaesthetic agents in the operating theatre. Can raising awareness and education of anaesthetists influence practice to reduce waste?
Scientific title
Low With the Flow; The effect of education, visual prompts and a proposed accepted standard on waste reduction of anaesthetic gases in operating rooms.
Secondary ID [1] 309123 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Volatile anaesthetic agent waste 329219 0
Condition category
Condition code
Anaesthesiology 326178 326178 0 0
Anaesthetics
Public Health 327081 327081 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Raising awareness of the environmental and financial costs of volatile agents in the operating theatre and education as to how to reduce waste. The intervention will include education in the form of a 40 minute didactic powerpoint presentation at the start of the project.
Cognitive aids in the form of reminders to reduce flows will be placed on every anaesthetic machine in the theatre environment. These reminders will be checked weekly to ensure that they are still in place. A poster will also be placed in the anaesthetic department next to the daily rosters to remind anaesthetists of the low flow approach.
An outline of ways to reduce flows and waste will be distributed to all anaesthetists via the monthly bulletin which is delivered by email.
Anaesthetists will be asked to check their logbook to ensure compliance with the target.
In the initial phase after the education, one staff member will personally move through theatres to assess the compliance with the program and explain approaches for adjusting practice in real time.
Intervention code [1] 325573 0
Behaviour
Intervention code [2] 326232 0
Prevention
Comparator / control treatment
Volatile agent use will be collected from anaesthetic machine logbook histories over a 6-month time period. immediately prior to intervention.
Control group
Historical

Outcomes
Primary outcome [1] 334053 0
The change in the ratio of uptake to consumption of anaesthetic agent per case. will be assessed. This information will be collected from anaesthetic machine logbooks.
Timepoint [1] 334053 0
A selection of data will be collected from historical anaesthetic cases performed over a 6 month period immediately prior to the intervention. After intervention, information about uptake to consumption of, a selection of anaesthetic cases performed over a 6 month period will also be collected.
Secondary outcome [1] 419199 0
Average fresh gas flow rate per case will be collected from anaesthetic machine logbooks.
Timepoint [1] 419199 0
A selection of data will be collected from historical anaesthetic cases performed over a 6 month period immediately prior to the intervention. After intervention, information about fresh gas flows of, a selection of anaesthetic cases performed over a 6 month period will also be collected.

Eligibility
Key inclusion criteria
All patients presenting to St Vincent's hospital undergoing anaesthesia with inhalational agents in the operating theatre.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anaesthesia where a volatile anaesthetic agent was not used as the maintenance agent
Anaesthesia using gas induction

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Other
Other design features
A historical control using a selection of cases in the past will be used as a comparator. These cases will be selected from a six month period immediately prior to the intervention and information will be collected from anaesthetic machine logbooks.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2023
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
500
Accrual to date
250
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24198 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 39731 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 313326 0
Hospital
Name [1] 313326 0
St Vincent's Hospital
Country [1] 313326 0
Australia
Primary sponsor type
Individual
Name
Samuel Costello
Address
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade Fitzroy Victoria 3065 Australia
Country
Australia
Secondary sponsor category [1] 316054 0
None
Name [1] 316054 0
Address [1] 316054 0
Country [1] 316054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312549 0
St Vincent's Hospital Melbourne Human Research and Ethics Commitee
Ethics committee address [1] 312549 0
Research Governance Unit
St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy
Victoria
3065
Ethics committee country [1] 312549 0
Australia
Date submitted for ethics approval [1] 312549 0
06/05/2022
Approval date [1] 312549 0
28/06/2022
Ethics approval number [1] 312549 0
QA22017

Summary
Brief summary
Sevoflurane is used to induce and maintain anaesthesia. Use of this drug is associated with an environmental and financial impact.
Nitrous oxide is also used to maintain anaesthesia. After use in theatre, these gases are expelled to the environment outside the hospital and contribute to global warming. We have a responsibility to reduce waste and care for the enviroment. Use per case and waste will be reviewed. After a period of intervention including raising awareness and education, use per case and waste will be reevaluated to determine if the use, average flow rate and the ratio between uptake and consumption have fallen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125050 0
Dr Samuel Costello
Address 125050 0
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade Fitzroy Victoria 3065
Country 125050 0
Australia
Phone 125050 0
+61 392314193
Fax 125050 0
Email 125050 0
sam.costello@svha.org.au
Contact person for public queries
Name 125051 0
Dr Samuel Costello
Address 125051 0
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade Fitzroy Victoria 3065
Country 125051 0
Australia
Phone 125051 0
+61 392312211
Fax 125051 0
Email 125051 0
sam.costello@svha.org.au
Contact person for scientific queries
Name 125052 0
Dr Samuel Costello
Address 125052 0
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade Fitzroy Victoria 3065
Country 125052 0
Australia
Phone 125052 0
+61 392312211
Fax 125052 0
Email 125052 0
sam.costello@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data relating to the patient characteristics, gas type used, consumption, uptake and duration of the case will be shared.
When will data be available (start and end dates)?
Available at the completion of the trial until 5 years after publication
Available to whom?
Other researchers carrying out the same research in their own institution.
Available for what types of analyses?
Metaanalyses
How or where can data be obtained?
From the principal investigator via email on request
sam.costello@svha.org.au
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Victoria 3065


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.