Status:
NOT_YET_RECRUITING
IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
Lead Sponsor:
Rennes University Hospital
Conditions:
Prehospital Emergency
Neck Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
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, reduc...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06983873
Start Date
February 1 2026
End Date
June 1 2030
Last Update
January 2 2026
Active Locations (12)
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1
CHU Amiens-Picardie
Amiens, France
2
CHRU Besançon
Besançon, France
3
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
4
Hôpitaux La Rochelle Ré Aunis
La Rochelle, France