NCT06983873 IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
| NCT ID | NCT06983873 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Prehospital Emergency |
| Study Type | INTERVENTIONAL |
| Enrollment | 840 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 840 participants in total. It began in 2026-06-17 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.).
Contact & Investigator
François Saget, Md
PRINCIPAL INVESTIGATOR
CHU Rennes / Rennes University Hospital
Frequently Asked Questions
Who can join the NCT06983873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Prehospital Emergency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983873 currently recruiting?
Yes, NCT06983873 is actively recruiting participants. Contact the research team at marie-laure.gervais@chu-rennes.fr for enrollment information.
Where is the NCT06983873 trial being conducted?
This trial is being conducted at Amiens, France, Besançon, France, Corbeil-Essonnes, France, Grenoble, France and 10 additional locations.
Who is sponsoring the NCT06983873 clinical trial?
NCT06983873 is sponsored by Rennes University Hospital. The principal investigator is François Saget, Md at CHU Rennes / Rennes University Hospital. The trial plans to enroll 840 participants.