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

Not Applicable

Withdrawn

• Conditions: Cervical Spine Fractures; Injury of Cervical Spine
• Interventions: Other: Canadian C-Spine rule

• Registration Number: NCT01278511
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canadian C-Spine Rule	Canadian C-Spine rule	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Performance of the Canadian c-spine rule	Analyzed at the end of the pilot study in april 2011	Performance includes rule accuracy

Trial Locations

Locations (1)

Emergency Department of the University Hospitals, Catholic University Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium