Trial Outcomes & Findings for Evaluation of the Safety of C-Spine Clearance by Paramedics (NCT NCT01188447)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4034 participants

Primary outcome timeframe

within 30 days of enrollment

Results posted on

2017-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	4034
Overall Study COMPLETED	4034
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety of C-Spine Clearance by Paramedics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eligible Low-risk Trauma Patients n=4034 Participants 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.
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	2150 Participants n=5 Participants
Sex: Female, Male Male	1884 Participants n=5 Participants
Region of Enrollment Canada	4034 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days of enrollment

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

Outcome measures

Outcome measures
Measure	Eligible Low-risk Trauma Patients n=4034 Participants 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.
Adverse Events	1 Adverse event

SECONDARY outcome

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

Proportion of eligible low-risk patients transported without immobilization

Outcome measures

Outcome measures
Measure	Eligible Low-risk Trauma Patients n=4034 Participants 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.
Clearance Rate	2569 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Eligible Low-risk Trauma Patients n=4034 Participants 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.
Performance of the Canadian C-Spine Rule	91 percentage of injuries identified Interval 58.0 to 100.0

SECONDARY outcome

Timeframe: immediately following evaluation

Population: 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.

Time spent at scene (difference between Paramedic scene departure and arrival at patient side)

Outcome measures

Outcome measures
Measure	Eligible Low-risk Trauma Patients n=3 Participants 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.
Scene Time	18 Minutes Interval 1.0 to 147.0

SECONDARY outcome

Timeframe: immediately following evaluation

Population: 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.

Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)

Outcome measures

Outcome measures
Measure	Eligible Low-risk Trauma Patients n=3 Participants 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.
Average Contact Time	55 minutes Interval 5.0 to 428.0

Adverse Events

Eligible Low-risk Trauma Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Eligible Low-risk Trauma Patients n=4034 participants at risk 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.
Musculoskeletal and connective tissue disorders Missed C-Spine Injury	0.02% 1/4034 • Number of events 1

Additional Information

Dr. Christian Vaillancourt

Ottawa Hospital Research Institute

Phone: 613-798-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place