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Evaluation of the Safety of C-Spine Clearance by Paramedics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Fracture of Cervical Spine
Intervention Procedure: Canadian C-Spine Rule
Enrollment 4034
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 4034
Completed 4034
Not Completed 0
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 4034
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4034 participants
43
(16 to 99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4034 participants
Female
2150
  53.3%
Male
1884
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 4034 participants
4034
1.Primary Outcome
Title Adverse Events
Hide Description

Measures of safety will include:

  1. number of missed cervical spine injuries
  2. number of serious adverse outcomes
Time Frame within 30 days of enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 4034
Measure Type: Number
Unit of Measure: Adverse event
1
2.Secondary Outcome
Title Clearance Rate
Hide Description Proportion of eligible low-risk patients transported without immobilization
Time Frame Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eligible Patients
Hide Arm/Group Description:
eligible patients evaluated with the Canadian C-Spine Rule
Overall Number of Participants Analyzed 4034
Measure Type: Count of Participants
Unit of Measure: Participants
2569
  63.7%
3.Secondary Outcome
Title Performance of the Canadian C-Spine Rule
Hide Description

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
Time Frame Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 4034
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of injuries identified
91
(58 to 100)
4.Secondary Outcome
Title Scene Time
Hide Description Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
Time Frame immediately following evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 3,174
Mean (Full Range)
Unit of Measure: Minutes
18
(1 to 147)
5.Secondary Outcome
Title Average Contact Time
Hide Description Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)
Time Frame immediately following evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 3,175
Mean (Full Range)
Unit of Measure: minutes
55
(5 to 428)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eligible Low-risk Trauma Patients
Hide Arm/Group Description

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.

All-Cause Mortality
Eligible Low-risk Trauma Patients
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Eligible Low-risk Trauma Patients
Affected / at Risk (%) # Events
Total   0/4034 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eligible Low-risk Trauma Patients
Affected / at Risk (%) # Events
Total   1/4034 (0.02%)    
Musculoskeletal and connective tissue disorders   
Missed C-Spine Injury   1/4034 (0.02%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christian Vaillancourt
Organization: Ottawa Hospital Research Institute
Phone: 613-798-5555 ext 17012
EMail: cvaillancourt@ohri.ca
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01188447    
Other Study ID Numbers: 2009142-01H
First Submitted: August 20, 2010
First Posted: August 25, 2010
Results First Submitted: January 20, 2017
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017