Trial Review

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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 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
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
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
No documents have been uploaded by study researchers.

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.