Prehospital EmergencyIPSTRAUCNCT06983873
IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
A study testing adapted Canadian C-Spine rules in people with Prehospital Emergency and Neck Injury, run by Rennes University Hospital at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prehospital Emergency, Neck Injury, Neck Trauma
- What is being tested?
- adapted Canadian C-Spine rules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 14 sitesFrance
- Study dates
- 17 Jun 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.).
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
CHU Amiens-Picardie
Amiens
Emilien Arnaud, +33 (0)322088790, emilien.arnaud@chu-amiens.fr
Emilien Arnaud
- Not yet recruiting
CHRU Besançon
Besançon
Justin Outrey, +33 (0)381668117, joutrey@chu-besancon.fr
Justin Outrey
- Not yet recruiting
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes
Jean-Philippe Desclefs, +33 (0)161696169, jean-philippe.desclefs@chsf.fr
Jean-Philippe Desclefs
- Not yet recruiting
CHU Grenoble
Grenoble
Guillaume Dubaty, Pr, 4 76 76 75 75 ext. +33, GDebaty@chu-grenoble.fr
Guillaume Dubaty, Pr
- Not yet recruiting
Hôpitaux La Rochelle Ré Aunis
La Rochelle
Ombeline Susong, +33 (0)546455050, ombeline.susong@ght-atlantique17.fr
Ombeline Susong
- Not yet recruiting
AP-HM Timone
Marseille
Justine AUDOUARD, +33 (0)491384515, justine.audouard@ap-hm.fr
Justine Audouard
- Not yet recruiting
CHRU Nancy
Nancy
Tahar CHOUIHED, +33 (0)383851496, t.chouihed@chru-nancy.fr
Tahar Chouihed
- Recruiting
CHU Nantes
Nantes
Hugo de CARVAHLO, Md, 2 40 08 33 33 ext. +33, hugo.decarvalho@chu-nantes.fr
Hugo de CARVAHLO, Md
- Not yet recruiting
CHU Nice
Nice
Julie Contenti, +33 (0)492033242, contenti.j@chu-nice.fr
Julie Contenti
- Not yet recruiting
CHU Poitiers
Poitiers
Nicolas MARJANOVIC, +33 (0)5 49 44 44 44, nicolas.marjanovic@chu-poitiers.fr
Nicolas MARJANOVIC
- Not yet recruiting
CHU Reims
Reims
Stéphane Gennai, +33(0)326787602, sgennai@chu-reims.fr
Stéphane Gennai
- Recruiting
CHU Rennes
Rennes
François Saget, Md, +33 (0)299284321, francois.saget@chu-rennes.fr
Vincent Levrel, Md, +33 (0)299284321, vincent.levrel@chu-rennes.fr
- Not yet recruiting
CHU Toulouse
Toulouse
Xavier Dubucs, +33(0)561775919, dubucs.x@chu-toulouse.fr
Xavier Dubucs
- Not yet recruiting
Centre hospitalier Bretagne Atlantique
Vannes
Bertrand Boulanger, +33 (0)297014141, bertrand.boulanger@ch-bretagne-atlantique.fr
Bertrand Boulanger
About this study
Official title: Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
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.
Read the 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.
- Being tested
- adapted Canadian C-Spine rules
- Medical subject headings
- Neck Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted Canadian C-Spine rulesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CCRa | Experimental | Pre-hospital management follow the rules of CCRa for all patients included in all sites ranodmized in the CCRa arm Receives: Behavioral: adapted Canadian C-Spine rules |
| Control | No intervention | Patients included from all sites randomized in the control arm will be assessed according to standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients admitted to emergency service
Proportion of patients admitted to emergency following pre-hospital management of the traumatic event.
Measured: Day 1
Secondary outcomes (10)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: Day 1
Number of trained firefighters in fire stations
Percentage of professionals trained in the fire stations of the experimental group
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start17 Jun 2026
- Primary completionJan 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prehospital EmergencyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Saget, Md, Principal investigator, CHU Rennes / Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983873
- Sponsor's protocol ID
- 35RC22_8872_IPSTRAUC
- Other IDs
- 2024-A00636-41
- Acronym
- IPSTRAUC
- Status last verified
- Jun 2026
- First submitted
- 6 May 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 42114876
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
- ClinicalTrials.gov ID
- NCT06983873
- Acronym / sponsor ID
- IPSTRAUC / 35RC22_8872_IPSTRAUC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRa | Experimental | Behavioral: adapted Canadian C-Spine rulesPre-hospital management follow the rules of CCRa for all patients included in all sites ranodmized in the CCRa arm |
| Control | No intervention | –Patients included from all sites randomized in the control arm will be assessed according to standard practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted Canadian C-Spine rulesThe 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. | Behavioural | CCRa |
Primary outcome
Proportion of patients admitted to emergency service
Time frame: Day 1
Proportion of patients admitted to emergency following pre-hospital management of the traumatic event.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 42114876Saget 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Saget, Md principal investigator
CHU Rennes / Rennes University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted Canadian C-Spine rules in people with Prehospital Emergency and Neck Injury, run by Rennes University Hospital at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure Gervais, PhD (2 99 28 25 91 ext. +33, marie-laure.gervais@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients admitted to emergency service (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.