Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001648314
Ethics application status
Approved
Date submitted
17/11/2017
Date registered
21/12/2017
Date last updated
25/03/2021
Date data sharing statement initially provided
27/06/2019
Date results information initially provided
25/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the accuracy of bedside ultrasound to diagnose wrist fractures in children
Scientific title
BUCKLED: Bedside Ultrasound Conducted in Kids with suspected distal upper Limb fractures in the Emergency Department - a study of accuracy, tolerability and feasibility
Secondary ID [1] 293385 0
None
Universal Trial Number (UTN)
U1111-1205-3611
Trial acronym
BUCKLED: Bedside Ultrasound Conducted in Kids with suspected distal upper Limb fractures in the Emergency Department
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric forearm fracture 305521 0
Condition category
Condition code
Injuries and Accidents 304761 304761 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurse practitioners will utilise bedside ultrasound prospectively to evaluate children 4-16 years of age with a non-angulated distal forearm injury presenting to the emergency department. A convenience sample of 200 patients will be collected over a 12-month period to determine the accuracy of bedside ultrasound compared with standard radiographs. Eligible patients will be consented to have ultrasound performed prospectively prior to x-ray imaging.
Intervention code [1] 299638 0
Diagnosis / Prognosis
Comparator / control treatment
The findings of the ultrasound images with nurse practitioner interpretation will be compared to the reference standard of x-ray imaging reported by a paediatric radiologist.
Control group
Active

Outcomes
Primary outcome [1] 303986 0
Individual and overall sensitivities and specificities of nurse practitioners performing POCUS will be reported to determine diagnostic accuracy. A true positive will be when POCUS and x-ray imaging both detect a fracture. A false positive will be when the POCUS images are reported as a fracture when the x-ray imaging does not. A true negative will be when the POCUS and x-ray images do not detect a fracture. A false negative will be when the POCUS images do not detect a fracture when there is a fracture on x-ray. A standard 2x2 table will be used to calculate individual and pooled sensitivities and specificities.
Timepoint [1] 303986 0
Patients will be enrolled over an approximate 12 month period
Secondary outcome [1] 340644 0
Average length of imaging (ultrasound scanning will be compared to the average time for x-ray imaging).
Timepoint [1] 340644 0
The length of bedside ultrasound is defined by the time (minutes and seconds) it takes to locate the ultrasound machine, conduct the scan and save all images. Average time for x-ray imaging is defined by the time that the x-ray is ordered to the time that the patient receives their final x-ray image.
Secondary outcome [2] 340645 0
Pain scores as reported by the parent for both ultrasound and x-ray imaging using the Faces Pain Scale Revised (FPSR).
Timepoint [2] 340645 0
Pain will be recorded by the parent as the average pain (FPSR) score during both the POCUS and x-ray.
Secondary outcome [3] 341247 0
Pain scores as reported by the child for both ultrasound and x-ray imaging using the Faces Pain Scale Revised (FPSR).
Timepoint [3] 341247 0
Pain will be recorded by the child as the average pain (FPSR) score during both the POCUS and x-ray.
Secondary outcome [4] 341248 0
Preference of imaging modality by the nurse practitioner.
Timepoint [4] 341248 0
Satisfaction scores on a 5 point likert scale for POCUS versus x-ray imaging will be recorded.
Secondary outcome [5] 341249 0
Preference of the imaging modality by the care-giver/parent.
Timepoint [5] 341249 0
Satisfaction scores on a 5 point likert scale for POCUS versus x-ray imaging will be recorded.

Eligibility
Key inclusion criteria
• Children aged 4-16 years presenting to the emergency department
• Isolated, non-angulated distal third forearm injury being evaluated with radiography for suspected fracture
• Acute injury sustained within 1 week of presentation
Minimum age
4 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• External imaging has already been performed
• Known metabolic bone disease, such as osteogenesis imperfecta
• Suspicion of non-accidental injury
• Congenital bone malformation
• Compound fracture
• Neurovascular compromise
• Distracting injury
• Suspicion for hand fracture

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A convenience sample of 200 patients will be recruited across the sites over around a 12-month period. We will report individual sensitivities and specificities, with an overall pooled result calculated. Average scanning time, time to x-ray, length of stay and pain during procedure will also be noted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2018
Actual
5/02/2018
Date of last participant enrolment
Anticipated
15/01/2019
Actual
6/04/2019
Date of last data collection
Anticipated
15/01/2019
Actual
6/04/2019
Sample size
Target
200
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9419 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 18121 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298012 0
Hospital
Name [1] 298012 0
Lady Cilento Children's Hospital
Country [1] 298012 0
Australia
Primary sponsor type
Individual
Name
Kelly Foster
Address
Research Manager
Centre for Children's Health Research
62 Graham St
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 297084 0
None
Name [1] 297084 0
Address [1] 297084 0
Country [1] 297084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299048 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 299048 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 299048 0
Australia
Date submitted for ethics approval [1] 299048 0
08/11/2017
Approval date [1] 299048 0
16/11/2017
Ethics approval number [1] 299048 0
HREC/17/QRCH/239

Summary
Brief summary
Paediatric distal forearm fractures, usually of the radius, are a common presentation to the emergency department (ED). Buckle, or torus, fractures occur in children due to the deformation of their soft bone, without breech of cortex. The gold standard for diagnosis of these fractures is x-ray imaging, which can then be effectively treated with a wrist splint. It has also been demonstrated that they can be accurately diagnosed by a rapid ultrasound protocol that can be easily learnt. Ultrasound is not typically utilised in this fashion in a tertiary paediatric ED due to readily available x-ray imaging. However, regional services often have limited radiographic services after-hours. Nurse practitioners (NPs) are frontline workers in the ambulatory care area of the ED where they are heavily relied upon for the diagnosis and management of paediatric fractures. If it can be demonstrated that NPs with limited ultrasound experience can diagnose distal forearm buckle fractures with high accuracy after a short training course, there may be validity in similar front-line workers being trained in this modality in resource-limited environments.

This pilot study will determine the acceptability, tolerability (pain compared to radiograph), feasibility (time of scan), and the accuracy of NPs to diagnose buckle fractures using ultrasound compared to radiograph as the gold standard. The results from the pilot study would be used to inform the development of a larger multi-centre research project that incorporates regional sites.
Trial website
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 79106 0
Dr Peter Snelling
Address 79106 0
Level 7 (7F Directorate)
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld
4101
Country 79106 0
Australia
Phone 79106 0
+617 3068 1111
Fax 79106 0
Email 79106 0
[email protected]
Contact person for public queries
Name 79107 0
Peter Snelling
Address 79107 0
Level 7 (7F Directorate)
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld
4101
Country 79107 0
Australia
Phone 79107 0
+617 3068 1111
Fax 79107 0
Email 79107 0
[email protected]
Contact person for scientific queries
Name 79108 0
Peter Snelling
Address 79108 0
Level 7 (7F Directorate)
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld
4101
Country 79108 0
Australia
Phone 79108 0
+617 3068 1111
Fax 79108 0
Email 79108 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
No ethical approval sought for public release of data prior to trial commencement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Peter J Snelling, Philip Jones, Gerben Keijzers, D... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNurse practitioner administered point-of-care ultrasound compared with X-ray for children with clinically non-angulated distal forearm fractures in the ED: A diagnostic study.2021https://dx.doi.org/10.1136/emermed-2020-209689
N.B. These documents automatically identified may not have been verified by the study sponsor.