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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00636-41 | Other Identifier | ID-RCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRa | Experimental | Pre-hospital management follow the rules of CCRa for all patients included in all sites ranodmized in the CCRa arm |
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| Control | No Intervention | Patients included from all sites randomized in the control arm will be assessed according to standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted Canadian C-Spine rules | Behavioral | The CCRa are decision rules for pre-hospital cervical spine collar immobilization. They include three high-risk criteria indicating imaging, 5 low-risk criteria allowing assessment of cervical spine rotation, and finally the ability of patients to achieve limited active rotation. They have been designed and validated to avoid immobilization during transport to the emergency department without any significant cervical injury being missed. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients admitted to emergency service | Proportion of patients admitted to emergency following pre-hospital management of the traumatic event. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma | Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma: Upper limb trauma, lower limb trauma, head trauma, chest pain, abdominal pain, pelvic pain, suture wound. | Day 1 |
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Inclusion Criteria:
PATIENTS
PROFESSIONAL
Exclusion Criteria:
PATIENTS
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.).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Laure Gervais, PhD | Contact | 2 99 28 25 91 | +33 | marie-laure.gervais@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Saget, Md | CHU Rennes / Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114876 | Derived | Saget F, Levrel V, Reuter PG, Soulat L, Peschanski N, Bajeux E. Cluster-randomised-controlled trial evaluating the impact of implementing the Canadian C-Spine Rule in prehospital cervical spine trauma care by the French Emergency Medical Call Center: IPSTRAUC study - a protocol. BMJ Open. 2026 May 11;16(5):e110724. doi: 10.1136/bmjopen-2025-110724. |
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All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@chu-rennes.fr. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
Data availability after the primary publication of the results and until the database is deleted
Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
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| Rate of relevant management strategy | number of collars fitted and not fitted in a relevant manner in relation to the number of patients included in each of the two groups compared at day 14 | 14 days |
| Proportion of patients with cervical imagery at 14 days | Proportion of patients having undergone : - at least one cervical imaging within 14 days of the trauma (cervical X-rays, cervical CT or cervical MRI) and number of examinations carried out. | 14 days |
| Proportion of patients with at least one consultation for neck pain | Proportion of patients having had at least one consultation for neck pain in the 30 days following the trauma (general practitioner in town or visit to the emergency department), number of consultations per patient and delay in relation to the initial treatment. | 30 days |
| Cost of patient care | Cost of patient care at D30 from the point of view of the French National Health Insurance (transport, medical and paramedical consultations, cervical imaging, emergency room visits, hospitalisation). | 30 days |
| ulcer complication rate of cervical collar immobilisation | - Percentage of patients with redness at the point of cervical collar compression compatible with an early stage of stage 1 pressure ulcer according to the National Pressure Ulcer Advisory Panel's classification of the different stages. | Day 1 |
| Overview of practices and organizations of firefighters in fire stations | Benefits and difficulties perceived in the adoption of new practices by teams of first-aiders and emergency medical service regulators | 18 months |
| Proportion of patients with cervical imagery at 30 days | Proportion of patients having undergone : - at least one cervical imaging within 30 days of the trauma (cervical X-rays, cervical scanner or cervical MRI) and number of examinations performed | 30 days |
| pain-linked complication rate of cervical collar immobilisation | - Assessment of pain in patients before and after fitting the cervical collar, using the Numerical Pain Scale (NPS): the NPS ranges from 0 to 10 (0 = no pain, 10 = unbearable pain). | Day 1 |
| Number of trained firefighters in fire stations | Percentage of professionals trained in the fire stations of the experimental group | 18 months |
| CHRU Besançon | Not yet recruiting | Besançon | France |
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| Centre Hospitalier Sud-Francilien | Not yet recruiting | Corbeil-Essonnes | France |
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| CHU Grenoble | Not yet recruiting | Grenoble | France |
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| Hôpitaux La Rochelle Ré Aunis | Not yet recruiting | La Rochelle | France |
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| AP-HM Timone | Not yet recruiting | Marseille | France |
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| CHRU Nancy | Not yet recruiting | Nancy | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| CHU Nice | Not yet recruiting | Nice | France |
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| CHU Poitiers | Not yet recruiting | Poitiers | France |
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| CHU Reims | Not yet recruiting | Reims | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU Toulouse | Not yet recruiting | Toulouse | France |
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| Centre hospitalier Bretagne Atlantique | Not yet recruiting | Vannes | France |
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| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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