Evaluation of the Safety of C-Spine Clearance by Paramedics

Fracture of Cervical Spine Clinical Trial

Official title:

Evaluation of the Safety of C-Spine Clearance by Paramedics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188447
• Other study ID #: 2009142-01H
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: April 28, 2016
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fracture of Cervical Spine

Intervention

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.

Locations

Country	Name	City	State
Canada	Ottawa Paramedic Service	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Missed cervical spine injuries, fractures and serious adverse events	Measures of safety will include: number of missed cervical spine injuries; number of serious adverse outcomes	following ED visit and 30 days after enrollment	Yes
Secondary	Clinical Impact	Measures of clinical impact will include: proportion of low-risk patients transported without immobilization; time spent in the field before transport; time from emergency department arrival to transfer of patient care to emergency department staff; total patient length of stay in the emergency department	Measures of clinical impact will be assessed immediately following the patient's ED visit	No
Secondary	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	These outcomes will be analyzed at the completion of the study.	No