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Evaluation of the Safety of C-Spine Clearance by Paramedics

Primary Purpose

Fracture of Cervical Spine

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Canadian C-Spine Rule
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fracture of Cervical Spine focused on measuring cervical-spine injuries, cervical-spine fractures, spinal cord injury, neck injury, Canadian C-Spine Rule, paramedics, emergency medical services

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ottawa Paramedic Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eligible low-risk trauma patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse Events
Measures of safety will include: number of missed cervical spine injuries number of serious adverse outcomes

Secondary Outcome Measures

Clearance Rate
Proportion of eligible low-risk patients transported without immobilization
Performance of the Canadian C-Spine Rule
Measurements of the performance of the rule will include: rule accuracy paramedic accuracy of interpretation paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule
Scene Time
Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
Average Contact Time
Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)

Full Information

First Posted
August 20, 2010
Last Updated
April 26, 2017
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01188447
Brief Title
Evaluation of the Safety of C-Spine Clearance by Paramedics
Official Title
Evaluation of the Safety of C-Spine Clearance by Paramedics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Cervical Spine
Keywords
cervical-spine injuries, cervical-spine fractures, spinal cord injury, neck injury, Canadian C-Spine Rule, paramedics, emergency medical services

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4034 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eligible low-risk trauma patients
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Canadian C-Spine Rule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Measures of safety will include: number of missed cervical spine injuries number of serious adverse outcomes
Time Frame
within 30 days of enrollment
Secondary Outcome Measure Information:
Title
Clearance Rate
Description
Proportion of eligible low-risk patients transported without immobilization
Time Frame
Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
Title
Performance of the Canadian C-Spine Rule
Description
Measurements of the performance of the rule will include: rule accuracy paramedic accuracy of interpretation paramedic agreement and level of comfort with the decision suggested by 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.
Title
Scene Time
Description
Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
Time Frame
immediately following evaluation
Title
Average Contact Time
Description
Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)
Time Frame
immediately following evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Vaillancourt, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Paramedic Service
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21284880
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of the Safety of C-Spine Clearance by Paramedics

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