Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital

A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278511

Enrollment

Registered

2011-01-19

Start date

2011-01-31

Completion date

Unknown

Last updated

2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spine Fractures, Injury of Cervical Spine

Keywords

Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates

Brief 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.

Interventions

OTHERCanadian C-Spine rule

Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Missed cervical spine injuries and fractures	At the first visit to the emergency department until 30 days after inclusion

Secondary

Measure	Time frame	Description
Performance of the Canadian c-spine rule	Analyzed at the end of the pilot study in april 2011	Performance includes rule accuracy
Level of comfort	Analyzed at the end of the pilot study in april 2011	Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026