Evaluation of the Nursing C-Spine (Phase IV)

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. Identifier: NCT01353352
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : May 13, 2011
Canadian Institutes of Health Research (CIHR)
Information provided by:
Ottawa Hospital Research Institute

Brief Summary:
Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian EDs. While the majority of these cases represent soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and approximately 10,000 suffer spinal cord injury. There are no readily available national Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only 0.9% of these patients are found to have cervical spine fractures or dislocations.

Condition or disease Intervention/treatment Phase
Fracture of Cervical Spine Fracture Dislocation of Cervical Spine Other: Clinical decision rule - clearing the c-spine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3633 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety of C-Spine Clearance by Emergency Department Triage Nurses (Phase IV)
Study Start Date : January 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Cervical spine injury
We enrolled consecutive alert adults who were in stable condition and who presented with potential cervical spine injury after acute blunt trauma, including patients with posterior neck pain and those presenting by ambulance with immobilization of the cervical spine.
Other: Clinical decision rule - clearing the c-spine
The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients.

Primary Outcome Measures :
  1. Determine safety: Number of missed CSI & Number of serious adverse outcomes Determine clinical impact: C-spine clearance rates by nurses & Lengths of time [ Time Frame: Dec 2010 ]

Secondary Outcome Measures :
  1. Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule & Nurse comfort with and use of the rule. [ Time Frame: Dec 2010 ]
  2. Evaluate performance [ Time Frame: December 2010 ]
    Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule & Nurse comfort with and use of the rule.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

The investigators will enroll consecutive alert, stable adults presenting to the study hospital EDs with potential c-spine injury after sustaining acute blunt trauma. These will be patients presenting with neck pain or with c-spine immobilization on an ambulance stretcher. Patient eligibility will be determined based on these criteria at the time of arrival in the ED.

  • "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck), and/or ii) presentation by ambulance with c-spine immobilization after injury (typically backboard and collar).
  • "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands).
  • "Stable" refers to normal vital signs as defined by the Revised Trauma Score31 (systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute).
  • "Acute" refers to injury within the past 48 hours.

Exclusion Criteria:

  • Patients under the age of 16 years,
  • Patients who do not satisfy the definition of "potential c-spine injury" as defined above (for example, patients with neither neck pain nor arriving with ambulance c-spine immobilization will be excluded),
  • Patients with Glasgow Coma Scale score less than 15,
  • Patients with unstable vital signs (systolic BP < 90; respiratory rate less than 10 or more than 24),
  • Patients whose injury occurred more than 48 hours previously,
  • Patients with penetrating trauma from stabbing or gunshot wound,
  • Patients with acute paralysis (paraplegia, quadriplegia),
  • Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery),
  • Patients who return for reassessment of the same injury, or
  • Patients referred from another hospital.

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 identifier (NCT number): NCT01353352

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Ian G Stiell, MD Ottawa Hospital Research Institute

Responsible Party: Dr Ian Stiell, Principal Investigator, Ottawa Hospital Research Institutute & University of Ottawa Identifier: NCT01353352     History of Changes
Other Study ID Numbers: MOP-86709
2007542-01H ( Other Identifier: Ottawa Hospital REB )
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by Ottawa Hospital Research Institute:
Clinical Decision Rule

Additional relevant MeSH terms:
Fractures, Bone
Fracture Dislocation
Wounds and Injuries
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases