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Clinical Trials/NCT01278511
NCT01278511WithdrawnNot Applicable

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

KU Leuven2 sites in 1 countryStarted: January 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
KU Leuven
Locations
2
Primary Endpoint
Missed cervical spine injuries and fractures
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
  • •Alert: GCS ≥ 14
  • •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

Outcomes

Primary Outcomes

Missed cervical spine injuries and fractures

Time Frame: At the first visit to the emergency department until 30 days after inclusion

Secondary Outcomes

  • Level of comfort(Analyzed at the end of the pilot study in april 2011)
  • Performance of the Canadian c-spine rule(Analyzed at the end of the pilot study in april 2011)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pieter Jan Van Asbroeck

Dr. Pieter Jan Van Asbroeck

KU Leuven

Study Sites (2)

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