NCT01278511

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

First QC Date

January 13, 2011

Last Update Submit

January 26, 2016

Conditions

Injury of Cervical SpineCervical Spine Fractures

Keywords

Canadian C-Spine RulePrehospital Emergency CareCervical Spine InjuriesCervical Spine FracturesEmergency Medicine Undergraduates

Outcome Measures

Primary Outcomes (1)

  • Missed cervical spine injuries and fractures

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

Secondary Outcomes (2)

  • Performance of the Canadian c-spine rule

    Analyzed at the end of the pilot study in april 2011

  • Level of comfort

    Analyzed at the end of the pilot study in april 2011

Study Arms (1)

Canadian C-Spine Rule

EXPERIMENTAL
Other: Canadian C-Spine rule

Interventions

Canadian C-Spine ruleOTHER

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

Canadian C-Spine Rule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department of the University Hospitals, Catholic University Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

  • Koen Bronselaer, MD, PhD

    Emergency Department of the University Hospitals, Catholic University Leuven

    STUDY DIRECTOR

  • Marc Sabbe, MD, PhD

    Emergency Department of the University Hospitals, Catholic University Leuven

    PRINCIPAL INVESTIGATOR

  • Pieter Jan Van Asbroeck, Drs

    Emergency Department of the University Hospitals, Catholic University Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pieter Jan Van Asbroeck

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

BE(1)