Evaluation of the Safety of C-Spine Clearance by Paramedics

NCT01188447 | Completed Results DMC

• 1 other identifier: 2009142-01H
• Study Type: interventional
• Target: 4,034
• Locations: 1 country
• Sites: 1

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

Keywords

cervical-spine injuries; cervical-spine fractures; spinal cord injury; neck injury; Canadian C-Spine Rule; paramedics; emergency medical services

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Measures of safety will include: 1. number of missed cervical spine injuries 2. number of serious adverse outcomes

  within 30 days of enrollment

Secondary Outcomes (4)

• Clearance Rate

  Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit

• Performance of the Canadian C-Spine Rule

  Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.

• Scene Time

  immediately following evaluation

• Average Contact Time

  immediately following evaluation

Study Arms (1)

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.

Procedure: Canadian C-Spine Rule

Interventions

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.

Eligible low-risk trauma patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Paramedic Service

Ottawa, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 21284880 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Neck Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Christian Vaillancourt
• Organization: Ottawa Hospital Research Institute

cvaillancourt@ohri.ca

613-798-5555

Study Officials

• Christian Vaillancourt, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 25, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)