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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Katholieke Universiteit Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01278511
First received: January 13, 2011
Last updated: February 18, 2011
Last verified: January 2011
History of Changes
  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
Fracture of Cervical Spine
 Other: Canadian C-Spine rule

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Performance of the Canadian c-spine rule [ Time Frame: Analyzed at the end of the pilot study in april 2011 ] [ Designated as safety issue: No ]
    Performance includes rule accuracy

  • Level of comfort [ Time Frame: Analyzed at the end of the pilot study in april 2011 ] [ Designated as safety issue: No ]
    Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol


Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278511

Contacts
Contact: Koen Bronselaer, MD, PhD +32 16 344639 koen.bronselaer@uzleuven.be
Contact: Pieter Jan Van Asbroeck, Drs + 32 497 139013 pjvanasbroeck@gmail.com

Locations
Belgium
Emergency Department of the University Hospitals, Catholic University Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Koen Bronselaer, MD, PhD     +32 16 344639     koen.bronselaer@uzleuven.be    
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

No publications provided

Responsible Party: Koen Bronselaer, MD, PhD, Emergency Department of the University Hospitals, Catholic University Leuven
ClinicalTrials.gov Identifier: NCT01278511     History of Changes
Other Study ID Numbers: S52940
Study First Received: January 13, 2011
Last Updated: February 18, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013