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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014