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Evaluation of the Safety of C-Spine Clearance by Paramedics

This study is currently recruiting participants.
Verified March 2012 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01188447
First received: August 20, 2010
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.


Condition Intervention
Fracture of Cervical Spine
 Procedure: 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: Evaluation of the Safety of C-Spine Clearance by Paramedics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Missed cervical spine injuries, fractures and serious adverse events [ Time Frame: following ED visit and 30 days after enrollment ] [ Designated as safety issue: Yes ]

    Measures of safety will include:

    1. number of missed cervical spine injuries
    2. number of serious adverse outcomes


Secondary Outcome Measures:
  • Clinical Impact [ Time Frame: Measures of clinical impact will be assessed immediately following the patient's ED visit ] [ Designated as safety issue: No ]

    Measures of clinical impact will include:

    1. proportion of low-risk patients transported without immobilization
    2. time spent in the field before transport
    3. time from emergency department arrival to transfer of patient care to emergency department staff
    4. total patient length of stay in the emergency department

  • Performance of the Canadian C-Spine Rule [ Time Frame: These outcomes will be analyzed at the completion of the study. ] [ Designated as safety issue: No ]

    Measurements of the performance of the rule will include:

    1. rule accuracy
    2. paramedic accuracy of interpretation
    3. paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule


Estimated Enrollment: 3000
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Canadian C-Spine Rule
    Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive alert, stable adults evaluated by the paramedics with potential c-spine injury after sustaining acute blunt trauma. Patient eligibility will be determined at the time of paramedic arrival at the scene based on the following criteria:

  • "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either:

    • neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck),
    • no neck pain but some visible injury above the clavicles, and/or
    • neither neck pain nor visible injury, but significant mechanism of injury as determined by the paramedic at the scene.
  • "Alert" is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and follows commands).
  • "Stable" refers to normal vital signs(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 4 hours.

Exclusion Criteria:

  • Patients under the age of 16 years,
  • 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), or
  • Patients referred from another hospital and transported between facilities.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188447

Contacts
Contact: Christian Vaillancourt, MD 613-798-5555 ext 17012 cvaillancourt@ohri.ca
Contact: Manya Charette, MSc 613-798-5555 ext 17758 mancharette@ohri.ca

Locations
Canada, Ontario
Ottawa Paramedic Service Recruiting
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Christian Vaillancourt, MD Ottawa Hospital Research Institute
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01188447     History of Changes
Other Study ID Numbers: 2009142-01H
Study First Received: August 20, 2010
Last Updated: March 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
cervical-spine injuries
cervical-spine fractures
spinal cord injury
neck injury
 Canadian C-Spine Rule
paramedics
emergency medical services

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013