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Evaluation of the Safety of C-Spine Clearance by Paramedics

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.
 
ClinicalTrials.gov Identifier: NCT01188447
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE August 20, 2010
First Posted Date  ICMJE August 25, 2010
Results First Submitted Date  ICMJE January 20, 2017
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
Missed cervical spine injuries, fractures and serious adverse events [ Time Frame: following ED visit and 30 days after enrollment ]
Measures of safety will include:
  1. number of missed cervical spine injuries
  2. number of serious adverse outcomes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
  • Clinical Impact [ Time Frame: Measures of clinical impact will be assessed following the patient's ED visit ]
    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. ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety of C-Spine Clearance by Paramedics
Official Title  ICMJE Evaluation of the Safety of C-Spine Clearance by Paramedics
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Fracture of Cervical Spine
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: Canadian C-Spine Rule
Publications * Vaillancourt C, Charette M, Kasaboski A, Maloney J, Wells GA, Stiell IG. Evaluation of the safety of C-spine clearance by paramedics: design and methodology. BMC Emerg Med. 2011 Feb 1;11:1. doi: 10.1186/1471-227X-11-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
4034
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2010)
3000
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188447
Other Study ID Numbers  ICMJE 2009142-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ottawa Hospital Research Institute
Original Responsible Party Christian Vaillancourt, MD, Ottawa Hospital Research Institute
Current Study Sponsor  ICMJE Ottawa Hospital Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Christian Vaillancourt, MD Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP