IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRennes University Hospital

About this trial

The aim of the study is to evaluate the application of Canadian C-Spine rules adapted to pre-hospital settings in France in order to improve the appropriateness of cervical spine immobilisation, reduce unnecessary imaging examinations and optimise patient care pathways.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

GCS 15

Stable (no organ failure, SBP ≥ 90 mmHg, DBP ≥ 65 mmHg, RF between 10 and 24 cycles/min)

Cooperative (calm and obedient to instructions)

Victim of a closed cervical spine trauma treated in the pre-hospital setting (fire brigade and/or Mobile Emergency and Resuscitation Service (SMUR)).

Disqualifiers

Life-threatening organ damage

Cardiorespiratory arrest since the traumatic event in question

Polytrauma patient

Penetrating trauma or a supra-clavicular wound following a knife or firearm injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • adapted Canadian C-Spine rules

    Behavioral

    The CCRa are decision rules for pre-hospital cervical spine collar immobilization. They include three high-risk criteria indicating imaging, 5 low-risk criteria allowing assessment of cervical spine rotation, and finally the ability of patients to achieve limited active rotation. They have been designed and validated to avoid immobilization during transport to the emergency department without any significant cervical injury being missed.

Treatment groups

840 Participants
are divided into 2 treatment groups
Group A: CCRaExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients admitted to emergency service

Proportion of patients admitted to emergency following pre-hospital management of the traumatic event.

Time frame
Day 1

Secondary outcomes

1

Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma

Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma: Upper limb trauma, lower limb trauma, head trauma, chest pain, abdominal pain, pelvic pain, suture wound.

Time frame
Day 1
2

Rate of relevant management strategy

number of collars fitted and not fitted in a relevant manner in relation to the number of patients included in each of the two groups compared at day 14

Time frame
14 days
3

Proportion of patients with cervical imagery at 14 days

Proportion of patients having undergone : \- at least one cervical imaging within 14 days of the trauma (cervical X-rays, cervical CT or cervical MRI) and number of examinations carried out.

Time frame
14 days
4

Proportion of patients with at least one consultation for neck pain

Proportion of patients having had at least one consultation for neck pain in the 30 days following the trauma (general practitioner in town or visit to the emergency department), number of consultations per patient and delay in relation to the initial treatment.

Time frame
30 days

Other outcomes

Sponsors and contacts

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