Adapted Canadian C‑Spine rules for managing neck injuries in conscious, stable pre-hospital patients
Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
This project will test whether using Canadian C‑Spine rules adapted for pre-hospital teams helps first responders avoid unnecessary neck collars, imaging, and emergency visits for conscious, stable patients with recent neck trauma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 12 sites (Amiens and 11 other locations) |
| Trial ID | NCT06983873 on ClinicalTrials.gov |
What this trial studies
This interventional study trains firefighters and EMS physicians in France to apply Canadian C‑Spine rules adapted to the pre-hospital context when attending conscious, stable adults after recent closed cervical trauma. After the rules are applied by the trained responder, an EMS investigating physician makes the final decision about cervical immobilisation in collaboration with that responder. The study will track rates of collar use, imaging, emergency department referrals, and detection of clinically important cervical spine injuries to compare care pathways before and after CCRa implementation. The goal is to determine whether implementing CCRa in pre-hospital care can safely streamline patient management and reduce unnecessary resource use.
Who should consider this trial
Good fit: Ideal candidates are adults with GCS 15 who are cooperative and hemodynamically stable, treated by the fire brigade or SMUR within 48 hours of a closed cervical trauma and reachable by telephone.
Not a fit: Patients with life‑threatening organ damage, unstable vital signs, altered consciousness, penetrating neck injuries, or those outside the participating pre-hospital systems are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary neck immobilisation and imaging, shorten patient pathways, and lower avoidable emergency visits while maintaining safety.
How similar studies have performed: The Canadian C‑Spine rules are well validated in emergency department settings, but adapting and implementing them in pre-hospital EMS care in France is relatively novel and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Amiens and 11 other locations
- CHU Amiens-Picardie — Amiens, France (Not_yet_recruiting)
- CHRU Besançon — Besançon, France (Not_yet_recruiting)
- Centre Hospitalier Sud-Francilien — Corbeil-Essonnes, France (Not_yet_recruiting)
- Hôpitaux La Rochelle Ré Aunis — La Rochelle, France (Not_yet_recruiting)
- AP-HM Timone — Marseille, France (Not_yet_recruiting)
- CHRU Nancy — Nancy, France (Not_yet_recruiting)
- CHU Nice — Nice, France (Not_yet_recruiting)
- CHU Poitiers — Poitiers, France (Not_yet_recruiting)
- CHU Reims — Reims, France (Not_yet_recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- Centre hospitalier Bretagne Atlantique — Vannes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: François Saget, Md — CHU Rennes / Rennes University Hospital
- Study coordinator: Marie-Laure Gervais, PhD
- Email: marie-laure.gervais@chu-rennes.fr
- Phone: 2 99 28 25 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.