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

This study has been withdrawn prior to enrollment.
(Not feasible)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278511
First Posted: January 19, 2011
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pieter Jan Van Asbroeck, Katholieke Universiteit Leuven
  Purpose
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.

Condition Intervention
Injury of Cervical Spine Cervical Spine Fractures Other: Canadian C-Spine rule

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting

Resource links provided by NLM:


Further study details as provided by Pieter Jan Van Asbroeck, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Missed cervical spine injuries and fractures [ Time Frame: At the first visit to the emergency department until 30 days after inclusion ]

Secondary Outcome Measures:
  • Performance of the Canadian c-spine rule [ Time Frame: Analyzed at the end of the pilot study in april 2011 ]
    Performance includes rule accuracy

  • Level of comfort [ Time Frame: 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


Enrollment: 0
Study Start Date: January 2011
Arms Assigned Interventions
Experimental: Canadian C-Spine Rule Other: Canadian 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278511


Locations
Belgium
Emergency Department of the University Hospitals, Catholic University Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Koen Bronselaer, MD, PhD Emergency Department of the University Hospitals, Catholic University Leuven
Principal Investigator: 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
  More Information

Responsible Party: Pieter Jan Van Asbroeck, Dr. Pieter Jan Van Asbroeck, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01278511     History of Changes
Other Study ID Numbers: S52940
First Submitted: January 13, 2011
First Posted: January 19, 2011
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by Pieter Jan Van Asbroeck, Katholieke Universiteit Leuven:
Canadian C-Spine Rule
Prehospital Emergency Care
Cervical Spine Injuries
Cervical Spine Fractures
Emergency Medicine Undergraduates

Additional relevant MeSH terms:
Spinal Fractures
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone