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Evaluation of the Safety of C-Spine Clearance by Paramedics

This study has been completed.
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: April 26, 2017
Last verified: April 2017
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Safety of C-Spine Clearance by Paramedics

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: within 30 days of enrollment ]

    Measures of safety will include:

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


Secondary Outcome Measures:
  • Clearance Rate [ Time Frame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit ]
    Proportion of eligible low-risk patients transported without immobilization

  • Performance of the Canadian C-Spine Rule [ Time Frame: Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. ]

    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

  • Scene Time [ Time Frame: immediately following evaluation ]
    Time spent at scene (difference between Paramedic scene departure and arrival at patient side)

  • Average Contact Time [ Time Frame: immediately following evaluation ]
    Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)


Enrollment: 4034
Study Start Date: January 2011
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eligible low-risk trauma patients
Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01188447

Locations
Canada, Ontario
Ottawa Paramedic Service
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

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
Results First Received: January 20, 2017
Last Updated: April 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 17, 2017