A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics
Primary Purpose
Neck Injuries
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Canadian C-Spine Rule
Sponsored by
About this trial
This is an interventional health services research trial for Neck Injuries focused on measuring Cervical spine injuries, Canadian C-spine Rule, Emergency Medical Services, Paramedic, Cervical spine fracture
Eligibility Criteria
Inclusion Criteria:
- Alert (Glasgow Coma Scale 15)
- Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute
- Acute blunt injury (within 48 hours of paramedic contact)
Exclusion Criteria:
- Age <8 years of age
- Penetrating trauma from stabbing or gunshot wound
- Acute paralysis (paraplegia, quadriplegia)
- Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)
- Referred from another hospital
Sites / Locations
- Ottawa Hospital Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Canadian C-Spine Rule
Arm Description
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule
Outcomes
Primary Outcome Measures
Proportion of patients transported with spinal immobilization
Proportion of patients feeling comfortable
Secondary Outcome Measures
Full Information
NCT ID
NCT02786966
First Posted
May 18, 2016
Last Updated
September 6, 2018
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ontario Spor Support Unit
1. Study Identification
Unique Protocol Identification Number
NCT02786966
Brief Title
A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics
Official Title
A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ontario Spor Support Unit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly.
The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury.
The investigators will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested the investigators include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. The investigators will also measure the impact on the ED, and how much money could be saved if more paramedics were allowed to use the CCR. The investigators will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.
Detailed Description
Paramedics in participating Ontario communities will all receive standardized training on the application of the Canadian C-Spine Rule (CCR). Once the training has been completed, paramedics will begin using the CCR to evaluate patients with potential c-spine injuries. For the first three months of the evaluation period, paramedics will use the CCR to evaluate eligible patients, but continue to use spinal immobilization for transport according to their existing protocols. After this validation period, participating services will be randomized in stepped wedge fashion in clusters of 4 services to actively use the CCR and selectively immobilize according to the CCR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Injuries
Keywords
Cervical spine injuries, Canadian C-spine Rule, Emergency Medical Services, Paramedic, Cervical spine fracture
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canadian C-Spine Rule
Arm Type
Other
Arm Description
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule
Intervention Type
Other
Intervention Name(s)
Canadian C-Spine Rule
Intervention Description
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule
Primary Outcome Measure Information:
Title
Proportion of patients transported with spinal immobilization
Time Frame
through study completion (one year)
Title
Proportion of patients feeling comfortable
Time Frame
through study completion (one year)
Other Pre-specified Outcome Measures:
Title
Proportion of patients with a pain score </= 4/10
Time Frame
through study completion (one year)
Title
Time from paramedic arrival at patient side to ED discharge or admission to hospital
Time Frame
through study completion (one year)
Title
Radiation Exposure
Description
radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit
Time Frame
through study completion (one year)
Title
Number of skin pressure injuries
Time Frame
through study completion (one year)
Title
Number of missed cervical spine injuries
Time Frame
through study completion (one year)
Title
Paramedic Field Time (arrival at patient side until departure for hospital)
Description
arrival at patient side until departure for hospital
Time Frame
through study completion (one year)
Title
Paramedic Hospital Time
Description
from arrival at emergency department to transfer of care to emergency department staff
Time Frame
through study completion (one year)
Title
Subsequent emergency department visits or hospital admissions
Description
within 30 days of initial visit
Time Frame
through study completion (one year)
Title
Subsequent clinic or family physician visits
Description
within 30 days of initial visit
Time Frame
through study completion (one year)
Title
Frequency of Cervical Spine diagnostic imaging
Description
at initial visit or within 30 days of initial visit
Time Frame
through study completion (one year)
Title
Cost Savings
Description
incremental cost saving per one immobilization avoided
Time Frame
through study completion (one year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alert (Glasgow Coma Scale 15)
Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute
Acute blunt injury (within 48 hours of paramedic contact)
Exclusion Criteria:
Age <8 years of age
Penetrating trauma from stabbing or gunshot wound
Acute paralysis (paraplegia, quadriplegia)
Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)
Referred from another hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Vaillancourt, MD, MSc
Organizational Affiliation
Ottawa Hospital Research Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32348267
Citation
Vaillancourt C, Charette M, Taljaard M, Thavorn K, Hall E, McLeod B, Fergusson D, Brehaut J, Graham I, Calder L, Ramsay T, Tugwell P, Kelly P, Cheskes S, Saskin R, Plint A, Osmond M, Macarthur C, Straus S, Rochon P, Prud'homme D, Dahrouge S, Marlin S, Stiell IG. Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial. JMIR Res Protoc. 2020 Jun 1;9(6):e16966. doi: 10.2196/16966.
Results Reference
derived
Learn more about this trial
A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics
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