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SOFTLY study

Be a SOFTLY champion!!!!

ED has approval for a research project comparing hard v soft collars for low-risk potential cervical spine injury requiring CT imaging.  Its about improving patient experience as well as safety. This project is being run by Emergency Registrar Rob Baker.

The change for us is the patient will initially be put in either a hard or soft collar based on randomization – all other care is unchanged.

The project will start on June 21 and run for about 12 weeks.

We need on-floor champions (medical and nursing) to make this happen.  The more champions the better!


You can help by:

  • talking about this with your colleagues
  • reassuring other clinicians that a soft collar is OK if it is a “soft collar week”
  • Becoming a research champion!


To nominate as a champion please contact

<>, <> or <>


Title: SOFTLY: Comparison of outcomes of rigid versus soft collar during ED investigation for potential cervical spine injury in low-risk blunt trauma patients
Short Title: SOFTLY study
Design: Unblinded, prospective quasi-randomised clinical trial of hard collar vs soft collar immobilisation of low-risk potential c-spine injuries during imaging
Study Centres: Emergency departments of Footscray and Sunshine hospitals
Study Question: In victims of blunt trauma who are at low risk for cervical spine injury but require a CT scan of their cervical spine, does the application of soft, foam collars result in improved patient outcomes when compared to immobilisation in a rigid cervical collar?
Study Objectives: Comparison of rigid (Philadelphia) collar immobilization versus soft collar for the outcomes of:
Primary Outcome: Patient-reported pain/discomfort related to neck immobilisation in the allocated collar type
Secondary Outcomes: Secondary outcomes include:

a)    Patient or clinician – reported skin damage (bruise, abrasion or wound) due to the collar

b)    Patient-reported ease of eating and drinking

c)    Patient or clinician reported episodes of aspiration

d)    Clinician-documented short term adverse neurological events defined as tingling, numbness or weakness in arms in a nerve root distribution

e)    Clinician-reported rate of non-compliance (removal or loosening of collar such that it is ineffective)

f)     Clinician-reported rate of agitation

g)    Incidence of cervical spine fracture or spinal cord injury

h)   Presence of a clinically important cervical spine injury

Inclusion Criteria: Adult patients (aged >18) who are assessed by paramedics, triage nurses or ED doctors as having potential cervical spine injury following blunt trauma and require CT scan of the cervical spine (neck bones) and would usually have a protective collar applied.
Exclusion Criteria: a)    Penetrating trauma

b)    Altered conscious state, including intoxication and significant dementia

c)    Abnormal physiological parameters (RR <8 or >20, HR <50 or >100, SBP <90, SpO2 <92%)

d)    Abnormal neurological findings on initial examination (including paraesthesia, sensory or motor abnormalities

e)    Pre-existing neurological disability


Number of Planned Participants: 194
Start date 21 June 2021
ANZCTR registration number ACTRN12621000286842p
Ethics approval number RMH 2021.35