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ClinicalTrials.gov ID

NCT06983873

Lead Sponsor

Rennes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

840Estimated

Last Update Posted

Jun 30, 2026Actual

Start Date

Jun 17, 2026Actual

Primary Completion Date

Jan 2029Estimated

Completion Date

Jun 2030Estimated

Official Title

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

Brief Summary

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.

Detailed Description

The aim of this study is to assess the feasibility and effectiveness of applying the Canadian C-Spine rules adapted (CCRa) to the pre-hospital context of the French healthcare system. The hypothesis is that the use of these rules will improve the appropriateness of cervical collar use, reduce the need for imaging examinations, reduce referrals to emergency departments and ensure the identification of patients really at risk of cervical spine injury. Collaboration between primary care providers, including the fire service, emergency medical services (EMS) and general practitioners, will be crucial to successful implementation.

As part of routine care, each time the fire brigade is called out to deal with a health problem, it carries out an assessment at the SAMU (emergency medical service) to decide how the patient should be referred and treated. During this assessment and call, patients meeting the inclusion criteria of our study will be selected. After inclusion, patients will be assessed by a firefighter or SMUR physician specifically trained in CCRa rules in addition to the study training. Following application of the CCRa rules, the final decision on immobilisation will be taken by an investigating physician from the EMS in consultation with the study-trained professional taking charge of the patient. If the CCRa accept the indication for a cervical collar, immobilisation will be performed and the patient will be referred to the emergency department of the investigating centre. When the decision rules do not include an indication for cervical imaging, the patient will not be immobilised with a cervical collar. In this second case, patients will not be referred to A&E unless they have another reason for being referred to A&E. All patients included in the study will be recalled 14 and 30 days after their trauma to collect data about their healthcare consumption. At day 14, answers to a questionnaire focusing on cervical lesion suspicion are also collected. If there is a suspicion of a lesion in the answers to the questionnaire , the patient will be called in by the investigating centre for a medical examination and more detailed imaging tests. In parallel, the practices and organizations of firefighters in the fire stations will be evaluated before the start of inclusions and the feasibility and reproducibility of implementing CCRa as part of the pre-hospital care organisation of the French healthcare system will be determined.

• Prehospital Emergency
• Neck Injury
• Neck Trauma
• Emergency Medical Services

• adapted Canadian C-Spine rules

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

PATIENTS

• 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)).
• Recent trauma (< 48 hours).
• Care regulated by the Emergency Medical Service (SAMU).
• Beneficiary of a social security scheme.
• Who can be contacted by telephone
• Have received oral and written information and have not objected to taking part in the study.

PROFESSIONAL

• Age ≥ 18 years
• Professional firefighter or EMS regulating doctor
• Professional who has received training in the protocol and, in the case of the experimental group, in the CCRa rules
• Fluency in French
• Having received oral and written information and not having objected to their participation in the study.

Exclusion Criteria:

PATIENTS

• 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
• Known spinal disease or previous spinal surgery (ankylosing spondylitis, rheumatic fever, spinal stenosis, cervical spine surgery).
• Acute paralysis (paraplegia, tetraplegia, hemiplegia, hemiparesis or documented sensory or motor deficit)
• Diagnosed osteogenesis imperfecta.
• Patients not regulated by EMS or transported to a hospital not participating in the study
• Pregnant or breast-feeding women
• Known situation of deprivation of liberty (safeguard of justice), guardianship or curatorship

PROFESSIONALS

- Persons referred to in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, persons deprived of their liberty, persons under guardianship, curatorship, etc.).

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Rennes University HospitalOTHER

t.chouihed@chru-nancy.fr+33 (0)383851496

hugo.decarvalho@chu-nantes.fr2 40 08 33 33 ext. +33

contenti.j@chu-nice.fr+33 (0)492033242

sgennai@chu-reims.fr+33(0)326787602

francois.saget@chu-rennes.fr+33 (0)299284321