Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital (NCT01278511) | Clinical Trial Compass
WithdrawnNot Applicable
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
Stopped: Not feasible
Belgium0Started 2011-01
Plain-language summary
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
* Alert: GCS ≥ 14
* Stable:
* systolic blood pressure ≥ 90 mmHg
* respiratory frequency 12 - 20 / min
* adult ≥ 18 years old
* Acute: ≤ 4
* Possible injury to the cervical spine:
* posterior neck pain following any mechanism
* no neck pain but visible injury above the clavicles
* no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury
Exclusion Criteria:
* Acute paralysis (quadriplegia, paraplegia)
* Penetrating trauma to the neck
* Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Missed cervical spine injuries and fractures
Timeframe: At the first visit to the emergency department until 30 days after inclusion