ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

SOFTLY

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neck injury

Spinal cord injury

Condition category

Condition code

Emergency medicine

Other emergency care

Injuries and Accidents

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]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

The control group is patients treated in a rigid (Philadelphia) collar.

Control group

Active

Outcomes

Primary outcome [1]

Patient-reported discomfort related to neck immobilisation in the allocated collar type assessed by a study-specific in person or telephone interview

Timepoint [1]

At the end of the treatment period

Secondary outcome [1]

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]

At the end of the treatment period

Secondary outcome [2]

Patient-reported ease of eating and drinking assessed by a study-specific in person or telephone interview

Timepoint [2]

At the end of the treatment period

Secondary outcome [3]

Patient reported episodes of aspiration assessed by a review of clinical records and a study-specific in person or telephone interview

Timepoint [3]

At the end of the treatment period

Secondary outcome [4]

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]

At the end of the treatment period

Secondary outcome [5]

Clinician-reported rate of non-compliance assessed by a review of the clinical record

Timepoint [5]

At then end of the treatment period

Secondary outcome [6]

Clinician-reported rate of agitation assessed by a review of the clinical record

Timepoint [6]

At the end of the treatment period

Secondary outcome [7]

Incidence of cervical spine fracture or spinal cord injury assessed by medical imaging report

Timepoint [7]

At the end of the treatment period

Secondary outcome [8]

Clinician reported skin damage, as documented in medical record

Timepoint [8]

At end of treatment period

Secondary outcome [9]

Clinical reported aspiration episode, as documented in medical record

Timepoint [9]

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?

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]

Footscray Hospital - Footscray

Recruitment hospital [2]

Sunshine Hospital - St Albans

Recruitment postcode(s) [1]

3011 - Footscray

Recruitment postcode(s) [2]

3021 - St Albans

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian College for Emergency Medicine Foundation

Address [1]

34 Westcott St
West Melbourne VIC 3003

Country [1]

Australia

Primary sponsor type

Government body

Name

Western Health

Address

Locked Bag 2, Footscray VIC 3011

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health HREC

Ethics committee address [1]

Royal Melbourne Hospital
300 Grattan St Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/02/2021

Approval date [1]

03/06/2021

Ethics approval number [1]

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

Prof Anne-Maree Kelly

Address

WHCRE
Western Health
Locked bag 2, Footscray VIC 3011

Country

Australia

Phone

+61 3 8395 8068

Fax

anne-maree.kelly@wh.org.au

Contact person for public queries

Name

Anne-Maree Kelly

Address

WHCRE
Western Health
Locked bag 2 Footscray VIC 3011

Country

Australia

Phone

+61 3 8345 6666

Fax

anne-maree.kelly@wh.org.au

Contact person for scientific queries

Name

Anne-Maree Kelly

Address

WHCRE
Western Health
Locked Bag 2, Footscray VIC 3011

Country

Australia

Phone

+61 3 8345 6666

Fax

anne-maree.kelly@wh.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?

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: anne-maree.kelly@wh.org.au

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

Source	Title	Year of Publication	DOI
Embase	SOFTLY: 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.	2023	https://dx.doi.org/10.1111/1742-6723.14195

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically