Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001334392
Ethics application status
Approved
Date submitted
11/09/2017
Date registered
19/09/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
22/05/2020
Date results provided
22/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Methoxyflurane metabolite (fluoride) presence in ambulance staff
Scientific title
Change in methoxyflurane metabolite (fluoride) presence in ambulance staff
Secondary ID [1] 292778 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluoride accumulation 304577 0
Condition category
Condition code
Public Health 303909 303909 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Emergency Medical Technicians in a metropolitan ambulance service will be using Penthrox (methoxyflurane) following newly introduced operational guidelines, occasionally administering up to 6mL to each patient as needed for pain relief. We expect they will be exposed to trace vapour (quantity not known) and that this may result in elevated serum fluoride in those staff. We will observe their serum fluoride over the course of 24 months to identify whether there is any evidence of fluoride accumulation.
Intervention code [1] 299012 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303241 0
Statistically significant changes in serum fluoride concentration.
Serum fluoride will be measured by ion specific electrode in buffered venous sample.
Timepoint [1] 303241 0
Methoxyflurane administration by ambulance staff will commence from June 2017, following an organisational implementation plan. We will measure staff serum fluoride at 0 months after introduction (during June 2017) to establish a baseline, and at 1, 4, 8, 12, 18 and 24 (primary endpoint) months after introduction of methoxyflurane into clinical practice.
Secondary outcome [1] 338336 0
Rate of change in serum fluoride concentration recorded over safe levels (<= 40 µmol/L).
Timepoint [1] 338336 0
0, 1, 4, 8, 12, 18 and 24 months following introduction of methoxyflurane into clinical practice, as described for the primary endpoint.

Eligibility
Key inclusion criteria
Ambulance officers rostered in full time patient contact role. Preferential recruitment of Emergency Medical Technicians over other qualifications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Staff members expected to leave the ambulance service in the course of the trial.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size 12 chosen to achieve 95% power to detect a 1 µmol/L difference in serum fluoride with p < 0.01, with up to 30% attrition due to change in role/injury or illness/cessation of employment/opting out.
Measures of change in blood fluoride over time will be calculated, including 95% confidence intervals of mean at each month tested, a series of one-sample t-tests of change in group mean vs. initial and vs. previous month (considering p < 0.05 as statistically significant), and regression models for change in blood fluoride over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
1/07/2017
Date of last data collection
Anticipated
30/06/2019
Actual
24/07/2019
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 9174 0
New Zealand
State/province [1] 9174 0
Wellington

Funding & Sponsors
Funding source category [1] 297408 0
Government body
Name [1] 297408 0
National Science Challenge funding (MBIE)
Country [1] 297408 0
New Zealand
Funding source category [2] 297411 0
Other Collaborative groups
Name [2] 297411 0
Medtec CORE (TEC)
Country [2] 297411 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Paul Docherty
Address
University of Canterbury
Private Bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 296402 0
Individual
Name [1] 296402 0
Serah Allison
Address [1] 296402 0
c/o Wellington Free Ambulance
PO Box 601
Wellington 6140
Country [1] 296402 0
New Zealand
Other collaborator category [1] 279691 0
Individual
Name [1] 279691 0
Dr. Dirk Pons
Address [1] 279691 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [1] 279691 0
New Zealand
Other collaborator category [2] 279692 0
Individual
Name [2] 279692 0
Dr. J Geoffrey Chase
Address [2] 279692 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [2] 279692 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298513 0
University of Canterbury Human Ethics Committee
Ethics committee address [1] 298513 0
Ethics committee country [1] 298513 0
New Zealand
Date submitted for ethics approval [1] 298513 0
24/04/2017
Approval date [1] 298513 0
23/05/2017
Ethics approval number [1] 298513 0
HEC 2017/23/LR

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

Contacts
Principal investigator
Name 77318 0
Ms Serah Allison
Address 77318 0
Wellington Free Ambulance
PO Box 601
Wellington 6140
Country 77318 0
New Zealand
Phone 77318 0
+64 27 486 6707
Fax 77318 0
Email 77318 0
[email protected]
Contact person for public queries
Name 77319 0
Serah Allison
Address 77319 0
Wellington Free Ambulance
PO Box 601
Wellington 6140
Country 77319 0
New Zealand
Phone 77319 0
+64 27 486 6707
Fax 77319 0
Email 77319 0
[email protected]
Contact person for scientific queries
Name 77320 0
Serah Allison
Address 77320 0
Wellington Free Ambulance
PO Box 601
Wellington 6140
Country 77320 0
New Zealand
Phone 77320 0
+64 27 486 6707
Fax 77320 0
Email 77320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For each participant: de-identification by assigning a "participant number"; blood test dates; blood fluoride results.
When will data be available (start and end dates)?
Personal data has already been provided to participants who requested their data.
Analysis is currently being undertaken, with a goal to publish in a peer-reviewed scientific journal before the end of 2020.
Aggregated data and analysis will be provided to participants when the paper has been accepted for publication.
Available to whom?
Tabulated anonymised blood fluoride results will be published in the journal article and PhD thesis, and thus available to the scientific community.
Available for what types of analyses?
Published blood fluoride results may be subsequently analysed by the scientific community however needed.
How or where can data be obtained?
Anonymised data will be incorporated into the published journal article and PhD thesis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8049Study protocol  [email protected]
8050Statistical analysis plan  [email protected]
8051Analytic code  [email protected]
8052Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISerum fluoride levels in ambulance staff after commencement of methoxyflurane administration compared to meta-analysis results for the general public2021https://doi.org/10.13075/ijomeh.1896.01704
N.B. These documents automatically identified may not have been verified by the study sponsor.