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.

introductionIn France, cervical spine trauma frequently results in systematic prehospital immobilisation with a cervical collar, despite a low incidence of clinically significant injuries. This practice may lead to unnecessary discomfort, delayed care and emergency department (ED) overcrowding. The Canadian C-Spine Rule (CCR) is a validated tool for identifying patients at low risk of cervical injury but its use is currently limited to ED settings. An adapted version (CCRa) has been validated in Canada for prehospital use, demonstrating safe reduction in immobilisation rates. This study aims to evaluate the feasibility, safety and clinical impact of CCRa implementation in the French prehospital emergency setting. The objectives are to assess whether the implementation of the CCRa by French prehospital emergency teams can safely reduce unnecessary cervical spine immobilisation in stable trauma patient, optimise imaging use and decrease ED overcrowding while maintaining patient safety. METHODS AND ANALYSIS: This is multicentre, cluster-randomised-controlled trial involving 16 Emergency Medical Call Center and their affiliated prehospital emergency services in France. Each centre will be randomised to either implement the CCRa or usual care with standard immobilisation practices. Alert adult patients (18-65 years) with suspected closed cervical spine trauma and Glasgow Coma Scale score of 15 will be included. The primary outcome is the proportion of patients with suspected cervical spine trauma who are transported to the ED. Secondary outcomes include the appropriateness of cervical spine immobilisation, use of cervical imaging, ED visits for neck pain, immobilisation-related complications, healthcare costs at 30 days, and feasibility and acceptability of CCRa implementation among prehospital professionals (effectiveness-implementation hybrid type 1 design). Quantitative data will be collected during prehospital care, ED admission and follow-up at days 14 and 30, while implementation outcomes will be assessed at the end of the intervention period using questionnaires and qualitative interviews. ETHICS AND DISSEMINATION: The study has been approved by a national ethics committee (CPP), the French competent authority and registered to the French National Authorities (ID-RCB 2024-A00636-41). It is funded by the French Ministry of Health via the 2023 PREPS programme (DGOS). Results will be published in a peer-reviewed journal and presented at relevant scientific meeting. The sponsor of the study is Rennes University Hospital. The findings may support broader CCRa implementation in European EMS systems. TRIAL REGISTRATION NUMBER: NCT06983873.