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New treatment option for Prehospital Emergency
Official title IPSTRAUC : Impact on Care Pathways of a New Management of Cervical Trauma in Conscious Patients Stable in Pre-hospital Care
ClinicalTrials.gov ID: NCT06983873
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)).
You likely can't join if
- 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).
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Besançon, France
- Corbeil-Essonnes, France
- Grenoble, France
- La Rochelle, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nice, France
- Poitiers, France
- Reims, France
- Rennes, France
- Toulouse, France
- Vannes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Besançon, France; Corbeil-Essonnes, France; Grenoble, France; La Rochelle, France; Marseille, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.