Evaluation of the Nursing C-Spine (Phase IV)

NCT01353352 | Completed Phase 4 DMC

• 2 other identifiers: MOP-867092007542-01H
• Study Type: interventional
• Target: 3,633
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Cervical Spine; Fracture Dislocation of Cervical Spine

Keywords

Evaluation; C-Spine; Nursing; Clinical Decision Rule

Outcome Measures

Primary Outcomes (1)

• Determine safety: Number of missed CSI & Number of serious adverse outcomes Determine clinical impact: C-spine clearance rates by nurses & Lengths of time

  Dec 2010

Secondary Outcomes (2)

• Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule & Nurse comfort with and use of the rule.

  Dec 2010

• Evaluate performance

  December 2010

Study Arms (1)

Cervical spine injury

OTHER

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

Interventions

Clinical decision rule - clearing the c-spine OTHER

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.

Cervical spine injury

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Study Officials

• Ian G Stiell, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: May 13, 2011
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

CA (1)