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NCT06983873
IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
Conditions: Prehospital Emergency, Neck Injury, Neck Trauma, Emergency Medical Services
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 840
Sponsor: Rennes University Hospital
Location: CHU Amiens-Picardie Amiens
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.
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.).
Source: ClinicalTrials.gov (NCT06983873). StuddyBuddy aggregates publicly available trial information.