Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000286842
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
16/03/2021
Date last updated
10/09/2023
Date data sharing statement initially provided
16/03/2021
Date results information initially provided
28/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
SOFTLY: Comparison of patient-reported discomfort of rigid versus soft collar during ED investigation for potential cervical spine injury in low-risk blunt trauma patients
Scientific title
SOFTLY: Comparison of patient-reported discomfort of rigid versus soft collar during ED investigation for potential cervical spine injury in low-risk blunt trauma patients
Secondary ID [1] 303169 0
None
Universal Trial Number (UTN)
Trial acronym
SOFTLY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck injury 320288 0
Spinal cord injury 320289 0
Condition category
Condition code
Emergency medicine 318214 318214 0 0
Other emergency care
Injuries and Accidents 318488 318488 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be assigned to care in either a rigid (Philadelphia) collar or a soft foam collar. The collar will be applied by a clinician (nurse or doctor) after arrival at the ED and before medical imaging. The collar will be removed after imaging and clinical assessment has ruled out a cervical spine injury. Adherence will; be checked by audit of medical records.
Intervention code [1] 319470 0
Treatment: Other
Intervention code [2] 319678 0
Treatment: Devices
Comparator / control treatment
The control group is patients treated in a rigid (Philadelphia) collar.
Control group
Active

Outcomes
Primary outcome [1] 326200 0
Patient-reported discomfort related to neck immobilisation in the allocated collar type assessed by a study-specific in person or telephone interview
Timepoint [1] 326200 0
At the end of the treatment period
Secondary outcome [1] 390485 0
Patient - reported skin damage due to the collar assessed by a review of clinical records and a study-specific in person or telephone interview
Timepoint [1] 390485 0
At the end of the treatment period
Secondary outcome [2] 390486 0
Patient-reported ease of eating and drinking assessed by a study-specific in person or telephone interview
Timepoint [2] 390486 0
At the end of the treatment period
Secondary outcome [3] 390487 0
Patient reported episodes of aspiration assessed by a review of clinical records and a study-specific in person or telephone interview
Timepoint [3] 390487 0
At the end of the treatment period
Secondary outcome [4] 390488 0
Clinician-documented short term adverse neurological events defined as tingling, numbness or weakness in arms in a nerve root distribution assessed by a review of the clinical record
Timepoint [4] 390488 0
At the end of the treatment period
Secondary outcome [5] 390489 0
Clinician-reported rate of non-compliance assessed by a review of the clinical record
Timepoint [5] 390489 0
At then end of the treatment period
Secondary outcome [6] 390490 0
Clinician-reported rate of agitation assessed by a review of the clinical record
Timepoint [6] 390490 0
At the end of the treatment period
Secondary outcome [7] 390491 0
Incidence of cervical spine fracture or spinal cord injury assessed by medical imaging report
Timepoint [7] 390491 0
At the end of the treatment period
Secondary outcome [8] 392712 0
Clinician reported skin damage, as documented in medical record
Timepoint [8] 392712 0
At end of treatment period
Secondary outcome [9] 392713 0
Clinical reported aspiration episode, as documented in medical record
Timepoint [9] 392713 0
At end of treatment period

Eligibility
Key inclusion criteria
Adults >18
Alert
Blunt trauma
Suspected neck injury
No neurological symptoms or signs
Stable vital signs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Penetrating trauma
Altered conscious state, including intoxication and significant dementia
Abnormal physiological parameters (RR <8 or >20, HR <50 or >100, SBP <90, SpO2 <92%)
Abnormal neurological findings on initial examination (including paraesthesia, sensory or motor abnormalities
Pre-existing neurological disability
Declined consent
Unable to understand sufficient English to verbally consent and/or understand PICF

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Quasi-randomised in blocks of 7 days by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis for the defined outcomes of interest will be analysed using random effects logistic regression and/or generalised estimation equation analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID 19 surge and Code Brown declaration for hospitals in Victoria
Date of first participant enrolment
Anticipated
5/04/2021
Actual
6/06/2021
Date of last participant enrolment
Anticipated
30/10/2021
Actual
30/11/2021
Date of last data collection
Anticipated
14/01/2022
Actual
Sample size
Target
320
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18414 0
Footscray Hospital - Footscray
Recruitment hospital [2] 18415 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 32509 0
3011 - Footscray
Recruitment postcode(s) [2] 32510 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 307576 0
Charities/Societies/Foundations
Name [1] 307576 0
Australian College for Emergency Medicine Foundation
Country [1] 307576 0
Australia
Primary sponsor type
Government body
Name
Western Health
Address
Locked Bag 2, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 308268 0
None
Name [1] 308268 0
Address [1] 308268 0
Country [1] 308268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307635 0
Melbourne Health HREC
Ethics committee address [1] 307635 0
Royal Melbourne Hospital
300 Grattan St Parkville VIC 3050
Ethics committee country [1] 307635 0
Australia
Date submitted for ethics approval [1] 307635 0
15/02/2021
Approval date [1] 307635 0
03/06/2021
Ethics approval number [1] 307635 0

Summary
Brief summary
Most traumatic spinal cord injuries (e.g. resulting in paraplegia and quadriplegia) happen at the time of the injury. A very small number might, in theory, be caused when an unstable fracture of the neck bones moves, injuring the spinal cord (delayed spinal cord injury).

To address this risk, it is common for ambulance services and emergency departments to place patients who they think might have an injury to the bones of their neck (cervical spine) in a protective collar. The aim is to minimise neck movement until imaging (x-rays or CT scans) can be performed. The rationale is that if there is a fracture of the neck bones, neck movement could cause the bone fragments to move resulting in damage to the spinal cord. Historically, rigid neck collars have been, and are, used. There is however no high-quality research data showing clear benefit of this approach.

This practice is now being questioned. Delayed spinal cord injury is an extremely rare event, there is no evidence that rigid collars prevent it and there is growing evidence of harm caused by rigid neck collars. This includes skin damage due to the pressure they apply, the risk of inhaling food or fluids when trying to eat or drink (aspiration) and damage to nerves in the neck. Anecdotally, patients report significant pain/discomfort and that eating or drinking is difficult. A proportion of patients are not able to tolerate the collar and remove it or loosen it such that it is ineffective. Some bodies have recommended a more selective strategy for limiting neck movement, including Norwegian and Danish guidelines and the Queensland Ambulance Service.

This study aims, in a prospective study, to compare use of a rigid collar (as is current practice) against the application of a soft, foam collar with an emphasis on patients’ experience – in particular the amount of discomfort experienced – as well as clinical outcomes including pressure injuries and choking (aspiration) events.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 107946 0
Prof Anne-Maree Kelly
Address 107946 0
WHCRE
Western Health
Locked bag 2, Footscray VIC 3011
Country 107946 0
Australia
Phone 107946 0
+61 3 8395 8068
Fax 107946 0
Email 107946 0
[email protected]
Contact person for public queries
Name 107947 0
Prof Anne-Maree Kelly
Address 107947 0
WHCRE
Western Health
Locked bag 2 Footscray VIC 3011
Country 107947 0
Australia
Phone 107947 0
+61 3 8345 6666
Fax 107947 0
Email 107947 0
[email protected]
Contact person for scientific queries
Name 107948 0
Prof Anne-Maree Kelly
Address 107948 0
WHCRE
Western Health
Locked Bag 2, Footscray VIC 3011
Country 107948 0
Australia
Phone 107948 0
+61 3 8345 6666
Fax 107948 0
Email 107948 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?
Data dictioneries
De-identified patient level data if approved by HREC
When will data be available (start and end dates)?
From publication for 5 years
Available to whom?
Researchers with similar projects, subject to HREC approval if required
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Direct contact with PI, Professor Anne-Maree Kelly Email: [email protected]


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 Baker R, Klim S, Poonian J, Ritchie P, Ng S, Kelly... [More Details]
Plain language summaryNo Use of a soft collar rather than a rigid collar in... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSOFTLY: Comparison of outcomes of rigid versus soft collar during emergency department investigation for potential cervical spine injury in low-risk blunt trauma patients - A pilot study.2023https://dx.doi.org/10.1111/1742-6723.14195
N.B. These documents automatically identified may not have been verified by the study sponsor.