Canadian C-Spine Rule Study - Full Text View

Sponsors and Collaborators:	Ottawa Health Research Institute Canadian Institutes of Health Research (CIHR)
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00290875

Purpose

Many thousands of trauma patients are seen in Canadian emergency departments each year. On rare occasions, such patients have a broken neck (cervical spine fracture) but in 98% of cases the x-rays ordered by the doctors are normal. The total cost of inexpensive but high volume tests such as neck x-rays adds considerably to rising health care costs. In addition, these patients are often immobilized with uncomfortable backboards and collars for many hours, tying up valuable space and time in our crowded emergency departments.

This research group recently developed and tested a highly accurate and reliable guideline called the 'Canadian C-Spine Rule' to help physicians be much more selective in their use of neck x-rays and to minimize the period of immobilization. This research project will evaluate the true effectiveness of the Rule when implemented with simple and inexpensive measures. This study will involve 14,000 patients in 12 busy emergency departments across Canada.

This Canadian C-Spine Rule is designed to allow physicians to be much more selective in their use of neck x-rays without the risk of missing a fracture or dislocation of the neck and to reduce the length of time of immobilization. Widespread use of the guideline could lead to large savings for our health care systems without jeopardizing patients and could greatly expedite care of trauma patients in our crowded emergency departments.

Condition	Intervention	Phase
Cspine Injury	Behavioral: Use of Xrays for diagnosis	Phase III

MedlinePlus related topics: Neck Injuries and Disorders X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Implementation of the Canadian C-Spine Rule: Phase III

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Cervical spine radiography ordering proportions

Secondary Outcome Measures:

Number of missed CSI Number of serious adverse outcomes Length of stay in ED Patient satisfaction Sustainability of the intervention Performance of the Canadian C-Spine Rule Economic evaluation measures

Estimated Enrollment:	14400
Study Start Date:	January 2003
Estimated Study Completion Date:	January 2008

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Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:All alert, stable adults presenting to the study hospital EDs after sustaining acute blunt trauma to the head or neck will be eligible and consecutive eligible trauma patients will be entered into the study. Patient eligibility will be determined based on these criteria at the time of arrival in the ED. a) "Trauma to the head and neck" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior midline or posterolateral aspect of the neck), or ii) no neck pain but all of: some visible injury above the clavicles, has not been ambulatory at any time, and associated with a high risk mechanism of injury (motor vehicle collision including motorcycle, pedestrian struck by a motor vehicle, bicycle collision, fall greater than or equal to 3 feet or 5 steps, diving, or contact sport with axial load to head and neck). b) "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands). c) "Stable" refers to normal vital signs as defined by the Revised Trauma Score24 (systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute). d) "Acute" refers to injury within the past 48 hours.

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Exclusion Criteria:a) Patients under the age of 16 years, b) Patients who do not satisfy the definition of "trauma to the head and neck" as defined above (for example, patients with neither neck pain nor visible injuries above the clavicles will be excluded), c) Patients with Glasgow Coma Scale score less than 15, d) Patients with unstable vital signs (systolic BP < 90; respiratory rate less than 10 or more than 24), e) Patients whose injury occurred more than 48 hours previously, f) Patients with penetrating trauma from stabbing or gunshot wound, g) Patients with acute paralysis (paraplegia, quadriplegia), h) Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or i) Patients who return for reassessment of the same injury.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290875

Contacts

Contact: Cathy Clement, RN

613-798-5555

cclement@ohri.ca

Locations

Canada, Ontario
Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Principal Investigator: Ian Stiell, MD

Sponsors and Collaborators

Ottawa Health Research Institute

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Ian Stiell, MD

OHRI

More Information

Study ID Numbers:	62795, 2002174-01H
Study First Received:	February 9, 2006
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00290875
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

cspine injury
radiography
clinical impact
dissemination

ClinicalTrials.gov processed this record on January 16, 2009