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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible low-risk trauma patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canadian C-Spine Rule | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Measures of safety will include:
| within 30 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance Rate | Proportion of eligible low-risk patients transported without immobilization | Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit |
| Performance of the Canadian C-Spine Rule |
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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:
"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:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Vaillancourt, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Paramedic Service | Ottawa | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21284880 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Measures of safety will include:
| Posted | Number | Adverse event | within 30 days of enrollment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Missed C-Spine Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christian Vaillancourt | Ottawa Hospital Research Institute | 613-798-5555 | 17012 | cvaillancourt@ohri.ca |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D019838 | Neck Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Measurements of the performance of the rule will include:
| Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. |
| Scene Time | Time spent at scene (difference between Paramedic scene departure and arrival at patient side) | immediately following evaluation |
| Average Contact Time | Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side) | immediately following evaluation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
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| Secondary | Clearance Rate | Proportion of eligible low-risk patients transported without immobilization | Posted | Count of Participants | Participants | Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit |
|
|
|
| Secondary | Performance of the Canadian C-Spine Rule | Measurements of the performance of the rule will include:
| Posted | Number | 95% Confidence Interval | percentage of injuries identified | Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. |
|
|
|
| Secondary | Scene Time | Time spent at scene (difference between Paramedic scene departure and arrival at patient side) | In order to be included in this analysis, a valid time for paramedic arrival and paramedic scene departure were required. Any patient refusing transport or missing time information was not included in the analysis. | Posted | Mean | Full Range | Minutes | immediately following evaluation |
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|
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| Secondary | Average Contact Time | Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side) | In order to be included in this analysis, and to have Contact Time calculated, both the paramedic arrival time and transfer of care time were required. Any case missing this information could not be included in the calculation. | Posted | Mean | Full Range | minutes | immediately following evaluation |
|
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| 0 |
| 4,034 |
| 1 |
| 4,034 |
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| D014947 | Wounds and Injuries |