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

N/ANot Yet RecruitingNCT06983873

Rennes University Hospital840 enrolled

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.

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.

Study Type

Conditions

Prehospital Emergency Neck Injury Neck Trauma Emergency Medical Services

Interventions

adapted Canadian C-Spine rulesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.).

Locations (12)

CHU Amiens-Picardie

Amiens, France

CHRU Besançon

Besançon, France

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, France

Hôpitaux La Rochelle Ré Aunis

La Rochelle, France

Outcomes

Primary Outcomes

Proportion of patients admitted to emergency service

Proportion of patients admitted to emergency following pre-hospital management of the traumatic event.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: Day 1

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

Time frame: 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.

Time frame: 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.

Time frame: 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).

Central Contacts

Marie-Laure Gervais, PhD

CONTACT

2 99 28 25 91 marie-laure.gervais@chu-rennes.fr

Data from ClinicalTrials.gov

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