IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care

Official title

Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care

Overview

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.

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 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.

Interventions

• Behavioral adapted Canadian C-Spine rules
  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.

Primary outcome measures

• Proportion of patients admitted to emergency service [Time frame: Day 1]

Secondary outcome measures (10)

• Proportion of patients with cervical spine trauma admitted to emergency departments for a reason other than cervical spine trauma [Time frame: Day 1]
• Rate of relevant management strategy [Time frame: 14 days]
• Proportion of patients with cervical imagery at 14 days [Time frame: 14 days]
• Proportion of patients with at least one consultation for neck pain [Time frame: 30 days]
• Cost of patient care [Time frame: 30 days]
• ulcer complication rate of cervical collar immobilisation [Time frame: Day 1]
• Overview of practices and organizations of firefighters in fire stations [Time frame: 18 months]
• Proportion of patients with cervical imagery at 30 days [Time frame: 30 days]
• pain-linked complication rate of cervical collar immobilisation [Time frame: Day 1]
• Number of trained firefighters in fire stations [Time frame: 18 months]

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 14 centers

• CHU Amiens-Picardie — Amiens
• CHRU Besançon — Besançon
• Centre Hospitalier Sud-Francilien — Corbeil-Essonnes
• CHU Grenoble — Grenoble
• Hôpitaux La Rochelle Ré Aunis — La Rochelle
• AP-HM Timone — Marseille
• CHRU Nancy — Nancy
• CHU Nantes — Nantes
• … and 6 more centers

Publications

• 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. PMID 42114876

Identifiers

NCT: NCT06983873 · 35RC22_8872_IPSTRAUC · 2024-A00636-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗