Evaluation of the Safety of C-Spine Clearance by Paramedics

• ClinicalTrials.gov Identifier: NCT01188447
• Recruitment Status: Completed
• First Posted: August 25, 2010
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Sponsor: Ottawa Hospital Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fracture of Cervical Spine	Procedure: Canadian C-Spine Rule	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4034 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of the Safety of C-Spine Clearance by Paramedics
• Study Start Date: January 2011
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Adverse Events [ Time Frame: within 30 days of enrollment ]

   Measures of safety will include:

   1. number of missed cervical spine injuries
   2. number of serious adverse outcomes

Secondary Outcome Measures :

1. Clearance Rate [ Time Frame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit ]
   Proportion of eligible low-risk patients transported without immobilization
2. Performance of the Canadian C-Spine Rule [ Time Frame: Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. ]

   Measurements of the performance of the rule will include:

   1. rule accuracy
   2. paramedic accuracy of interpretation
   3. paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule
3. Scene Time [ Time Frame: immediately following evaluation ]
   Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
4. Average Contact Time [ Time Frame: immediately following evaluation ]
   Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Ottawa Paramedic Service

Ottawa, Ontario, Canada

Sponsors and Collaborators

Ottawa Hospital Research Institute

Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Christian Vaillancourt, MD; Ottawa Hospital Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01188447
• Other Study ID Numbers: 2009142-01H
• First Posted: August 25, 2010
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ottawa Hospital Research Institute:

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

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries