Evaluation of the Safety of C-Spine Clearance by Paramedics

NCT ID: NCT01188447

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4034 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Fracture of Cervical Spine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Canadian C-Spine Rule

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Vaillancourt, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Paramedic Service

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 21284880 (View on PubMed)

Other Identifiers

2009142-01H

Identifier Type: -

Identifier Source: org_study_id