Fracture of Cervical SpineNCT01188447
Evaluation of the Safety of C-Spine Clearance by Paramedics
A study testing Canadian C-Spine Rule in people with Fracture of Cervical Spine, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fracture of Cervical Spine
- What is being tested?
- Canadian C-Spine Rule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,034 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Canadian C-Spine Rule
- Keywords
- cervical-spine injuries, cervical-spine fractures, spinal cord injury, neck injury, Canadian C-Spine Rule, paramedics, emergency medical services
- Medical subject headings
- Spinal Cord Injuries, Neck Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canadian C-Spine RuleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Canadian C-Spine Rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measures of safety will include:
- number of missed cervical spine injuries
- number of serious adverse outcomes
Measured: within 30 days of enrollment
Secondary outcomes (4)
Clearance Rate
Proportion of eligible low-risk patients transported without immobilization
Measured: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
Performance of the Canadian C-Spine Rule
Measurements of the performance of the rule will include:
- rule accuracy
- paramedic accuracy of interpretation
- paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule
Measured: Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.
Scene Time
Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
Measured: immediately following evaluation
Average Contact Time
Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)
Measured: immediately following evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of Cervical SpineStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Christian Vaillancourt, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188447
- Sponsor's protocol ID
- 2009142-01H
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2010
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21284880
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of C-Spine Clearance by Paramedics
- ClinicalTrials.gov ID
- NCT01188447
- Acronym / sponsor ID
- 2009142-01H
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,034 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible low-risk trauma patients | Experimental | Procedure: Canadian C-Spine RuleParamedics 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- "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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canadian C-Spine RuleParamedics 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. | Procedure or surgery | Eligible low-risk trauma patients |
Primary outcome
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
4 secondary outcomes
Clearance Rate
Time frame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
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.
Scene Time
Time frame: immediately following evaluation
Average Contact Time
Time frame: immediately following evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21284880Vaillancourt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Vaillancourt, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canadian C-Spine Rule in people with Fracture of Cervical Spine, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: within 30 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.