Trial Outcomes & Findings for A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics (NCT NCT02786966)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3646 participants

Primary outcome timeframe

Through study completion.

Results posted on

2025-10-17

Participant Flow

Unit of analysis: Paramedic Services

Participant milestones

Participant milestones
Measure	Sequence 1: Usual Care Months 1-3, Canadian C-Spine Rule Months 4-9 Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-3. Use of the Canadian C-Spine Rule to determine need for spinal immobilization for months 4-9.	Sequence 2: Usual Care Months 1-6, Canadian C-Spine Rule Months 7-9 Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-6. Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport for months 7-9.	Sequence 3: Usual Care Months 1-9 Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-9.
Step 1: Months 1-3 STARTED	351 4	285 4	169 3
Step 1: Months 1-3 COMPLETED	351 4	285 4	169 3
Step 1: Months 1-3 NOT COMPLETED	0 0	0 0	0 0
Step 2: Months 4-6 STARTED	758 4	471 4	244 3
Step 2: Months 4-6 COMPLETED	758 4	468 4	244 3
Step 2: Months 4-6 NOT COMPLETED	0 0	3 0	0 0
Step 3: Months 7-9 STARTED	552 4	591 4	225 3
Step 3: Months 7-9 COMPLETED	552 4	589 4	224 3
Step 3: Months 7-9 NOT COMPLETED	0 0	2 0	1 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Phase (Usual Care) n=1745 Participants Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).	Canadian C-Spine Rule n=1901 Participants Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.	Total n=3646 Participants Total of all reporting groups
Age, Continuous	48.0 years STANDARD_DEVIATION 21.9 • n=1745 Participants	46.5 years STANDARD_DEVIATION 21.9 • n=1901 Participants	47.2 years STANDARD_DEVIATION 21.0 • n=3646 Participants
Sex: Female, Male Female	876 Participants n=1745 Participants	998 Participants n=1901 Participants	1874 Participants n=3646 Participants
Sex: Female, Male Male	869 Participants n=1745 Participants	903 Participants n=1901 Participants	1772 Participants n=3646 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	1745 participants n=1745 Participants	1901 participants n=1901 Participants	3646 participants n=3646 Participants

PRIMARY outcome

Timeframe: Through study completion.

Outcome measures

Outcome measures
Measure	Control Phase (Usual Care) n=1740 Participants Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).	Canadian C-Spine Rule n=1885 Participants Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.
Proportion of Patients Transported With Spinal Immobilization	1334 Participants	813 Participants

PRIMARY outcome

Timeframe: At study completion

Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values \>=5 were considered to indicate discomfort.

Outcome measures

Outcome measures
Measure	Control Phase (Usual Care) n=1285 Participants Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).	Canadian C-Spine Rule n=1108 Participants Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.
Proportion of Patients Feeling Uncomfortable	883 Participants	654 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At study completion

Measured on a 10-point ordinal scale with increasing values indicating greater pain.

Outcome measures

Outcome measures
Measure	Control Phase (Usual Care) n=1423 Participants Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).	Canadian C-Spine Rule n=1333 Participants Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.
Proportion of Patients With a Pain Score </= 5/10	866 Participants	736 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of initial injury

Time from paramedic arrival at patient side to ED discharge or admission to hospital

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days from initial injury

radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (one year)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (one year)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of initial injury

arrival at patient side until departure for hospital

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (one year)

from arrival at emergency department to transfer of care to emergency department staff

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (one year)

within 30 days of initial visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within 30 days of initial injury

within 30 days of initial visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within 30 days of initial injury

at initial visit or within 30 days of initial visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion (one year)

incremental cost saving per one immobilization avoided

Outcome measures

Outcome data not reported

Adverse Events

Control Phase (Usual Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Canadian C-Spine Rule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manya Charette

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