Fracture of Cervical SpinePhase 4NCT01353352
Evaluation of the Nursing C-Spine (Phase IV)
A Phase 4 study testing Clinical decision rule - clearing the c-spine in people with Fracture of Cervical Spine and Fracture Dislocation of Cervical Spine, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian EDs. While the majority of these cases represent soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and approximately 10,000 suffer spinal cord… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture of Cervical Spine, Fracture Dislocation of Cervical Spine
- What is being tested?
- Clinical decision rule - clearing the c-spine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,633 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The investigators will enroll consecutive alert, stable adults presenting to the study hospital EDs with potential c-spine injury after sustaining acute blunt trauma. These will be patients presenting with neck pain or with c-spine immobilization on an ambulance stretcher. Patient eligibility will be determined based on these criteria at the time of arrival in the ED.
- "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck), and/or ii) presentation by ambulance with c-spine immobilization after injury (typically backboard and collar).
- "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands).
- "Stable" refers to normal vital signs as defined by the Revised Trauma Score31 (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 48 hours.
Who cannot join
- Patients under the age of 16 years,
- Patients who do not satisfy the definition of "potential c-spine injury" as defined above (for example, patients with neither neck pain nor arriving with ambulance c-spine immobilization will be excluded),
- Patients with Glasgow Coma Scale score less than 15,
- Patients with unstable vital signs (systolic BP < 90; respiratory rate less than 10 or more than 24),
- Patients whose injury occurred more than 48 hours previously,
- Patients with penetrating trauma from stabbing or gunshot wound,
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- Patients with acute paralysis (paraplegia, quadriplegia),
- Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery),
- Patients who return for reassessment of the same injury, or
- Patients referred from another hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety of C-Spine Clearance by Emergency Department Triage Nurses (Phase IV)
Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian EDs. While the majority of these cases represent soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and approximately 10,000 suffer spinal cord injury. There are no readily available national Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only 0.9% of these patients are found to have cervical spine fractures or dislocations.
Read the detailed description
Background: Canadian emergency departments (EDs) annually treat 1.3 million patients who have suffered blunt trauma from falls or motor vehicle collisions and who are at risk for cervical spine injury. Most such cases are alert and stable adults and less than 1% has a c-spine fracture. Most trauma victims transported in ambulances are protected by a backboard, collar, and sandbags and, on arrival at the ED, are sent to high acuity resuscitation rooms, where they remain fully immobilized for hours until physician assessment and radiography are complete. This prolonged immobilization is often unnecessary and adds considerably to patient discomfort and also adds to the burden of our overcrowded Canadian EDs in an era when they are under unprecedented pressures. These patients use valuable ED resuscitation room space.
Nurses usually do not evaluate the c-spine of trauma patients but the investigators believe that they should be able to safely assess alert and stable ambulance patients and "clear" the c-spine of low-risk cases on arrival at the triage station. Patients could then be much more rapidly, comfortably, and efficiently managed in other areas of the ED. An expanded role for nurse decision-making has the potential to improve trauma care efficiency in all Canadian hospitals. Very little research has been done in this area of nurses' clearing patient c-spines.
A clinical decision rule is derived from original research and is defined as a decision making tool that incorporates three or more variables from the history, examination, or simple tests. This Canadian C-Spine Rule (CCR) is comprised of simple clinical variables and was designed to allow clinicians to "clear" the c-spine without radiography and to decrease immobilization times. The investigators also validated the accuracy of the rule when used by physicians. The investigators have now finished a funded study to validate the accuracy and reliability of the CCR when used by ED triage nurses at 6 hospitals. The investigators completed a funded implementation trial at 12 Canadian hospitals to evaluate the impact on patients of the CCR when used by physicians.
Objectives: The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients. Specific objectives are to: 1) Determine safety by screening for: a) Missed fractures and b) Serious adverse outcomes; 2) Determine clinical impact by measuring: a) C-spine clearance rates by nurses, b) Length of time until c-spine clearance; 3) Evaluate performance of the Canadian C-Spine Rule for: a) Accuracy, b) Nurse accuracy in interpretation, and c) Nurse comfort and compliance.
Methods: The investigators propose a cohort study which evaluates outcomes during a 12-month period at 5 hospital EDs, including 3 community and 2 teaching hospital sites. Enrolled will be consecutive, alert and stable adult trauma patients presenting to the ED with neck pain or with c-spine immobilization on an ambulance stretcher. Participating will be ED triage nurses who previously underwent a structured educational strategy to learn the CCR and who successfully participated in the 24-month phase IIb validation study at the same sites. These nurses will be empowered by medical directive to "clear" the c-spine of patients according to the CCR, thus allowing them to remove c-spine immobilization and to triage patients to a less acute area of the ED. These outcomes will be assessed: 1) Measures of safety: a) Number of missed fractures, b) Number of serious adverse outcomes; 2) Measures of clinical impact: a) C-spine clearance rates by nurses, b) Length of stay in ED, and c) Patient satisfaction; 3) Performance of the Canadian C-Spine Rule: a) Accuracy, b) Nurse accuracy of interpretation, and c) Nurse comfort. The investigators estimate a sample size of 1,500 patients will be accrued.
Importance: This evaluation study (phase IV) is an essential step in the process of developing a new clinical decision rule / guideline for nurses to clear the c-spine. Once the investigators have established safety and potential impact in phase IV, the investigators can move to the final step (phase V), a multicenter implementation across Canada to study actual impact. The investigators believe that teaching ED triage nurses to clear the c-spine of very low-risk trauma patients has the potential to significantly improve the efficiency and comfort of patient care in our busy Canadian EDs. Ultimately, the investigators expect the results of this study to be used by ED triage nurses throughout Canada.
- Being tested
- Clinical decision rule - clearing the c-spine
- Keywords
- Evaluation, C-Spine, Nursing, Clinical Decision Rule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision rule - clearing the c-spineOther
The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients.
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine injury | Other | We enrolled consecutive alert adults who were in stable condition and who presented with potential cervical spine injury after acute blunt trauma, including patients with posterior neck pain and those presenting by ambulance with immobilization of the cervical spine. Receives: Other: Clinical decision rule - clearing the c-spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine safety: Number of missed CSI & Number of serious adverse outcomes Determine clinical impact: C-spine clearance rates by nurses & Lengths of time
Measured: Dec 2010
Secondary outcomes (2)
Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule & Nurse comfort with and use of the rule.
Measured: Dec 2010
Evaluate performance
Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule \& Nurse comfort with and use of the rule.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Ian G Stiell, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353352
- Sponsor's protocol ID
- MOP-86709
- Other IDs
- 2007542-01H
- Status last verified
- May 2011
- First submitted
- 13 Oct 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of C-Spine Clearance by Emergency Department Triage Nurses (Phase IV)
- ClinicalTrials.gov ID
- NCT01353352
- Acronym / sponsor ID
- MOP-86709
- Keywords
- Evaluation, C-Spine, Nursing, Clinical Decision Rule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,633 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian EDs. While the majority of these cases represent soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and approximately 10,000 suffer spinal cord injury. There are no readily available national Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only 0.9% of these patients are found to have cervical spine fractures or dislocations.
Detailed description
Background: Canadian emergency departments (EDs) annually treat 1.3 million patients who have suffered blunt trauma from falls or motor vehicle collisions and who are at risk for cervical spine injury. Most such cases are alert and stable adults and less than 1% has a c-spine fracture. Most trauma victims transported in ambulances are protected by a backboard, collar, and sandbags and, on arrival at the ED, are sent to high acuity resuscitation rooms, where they remain fully immobilized for hours until physician assessment and radiography are complete. This prolonged immobilization is often unnecessary and adds considerably to patient discomfort and also adds to the burden of our overcrowded Canadian EDs in an era when they are under unprecedented pressures. These patients use valuable ED resuscitation room space.
Nurses usually do not evaluate the c-spine of trauma patients but the investigators believe that they should be able to safely assess alert and stable ambulance patients and "clear" the c-spine of low-risk cases on arrival at the triage station. Patients could then be much more rapidly, comfortably, and efficiently managed in other areas of the ED. An expanded role for nurse decision-making has the potential to improve trauma care efficiency in all Canadian hospitals. Very little research has been done in this area of nurses' clearing patient c-spines.
A clinical decision rule is derived from original research and is defined as a decision making tool that incorporates three or more variables from the history, examination, or simple tests. This Canadian C-Spine Rule (CCR) is comprised of simple clinical variables and was designed to allow clinicians to "clear" the c-spine without radiography and to decrease immobilization times. The investigators also validated the accuracy of the rule when used by physicians. The investigators have now finished a funded study to validate the accuracy and reliability of the CCR when used by ED triage nurses at 6 hospitals. The investigators completed a funded implementation trial at 12 Canadian hospitals to evaluate the impact on patients of the CCR when used by physicians.
Objectives: The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients. Specific objectives are to: 1) Determine safety by screening for: a) Missed fractures and b) Serious adverse outcomes; 2) Determine clinical impact by measuring: a) C-spine clearance rates by nurses, b) Length of time until c-spine clearance; 3) Evaluate performance of the Canadian C-Spine Rule for: a) Accuracy, b) Nurse accuracy in interpretation, and c) Nurse comfort and compliance.
Methods: The investigators propose a cohort study which evaluates outcomes during a 12-month period at 5 hospital EDs, including 3 community and 2 teaching hospital sites. Enrolled will be consecutive, alert and stable adult trauma patients presenting to the ED with neck pain or with c-spine immobilization on an ambulance stretcher. Participating will be ED triage nurses who previously underwent a structured educational strategy to learn the CCR and who successfully participated in the 24-month phase IIb validation study at the same sites. These nurses will be empowered by medical directive to "clear" the c-spine of patients according to the CCR, thus allowing them to remove c-spine immobilization and to triage patients to a less acute area of the ED. These outcomes will be assessed: 1) Measures of safety: a) Number of missed fractures, b) Number of serious adverse outcomes; 2) Measures of clinical impact: a) C-spine clearance rates by nurses, b) Length of stay in ED, and c) Patient satisfaction; 3) Performance of the Canadian C-Spine Rule: a) Accuracy, b) Nurse accuracy of interpretation, and c) Nurse comfort. The investigators estimate a sample size of 1,500 patients will be accrued.
Importance: This evaluation study (phase IV) is an essential step in the process of developing a new clinical decision rule / guideline for nurses to clear the c-spine. Once the investigators have established safety and potential impact in phase IV, the investigators can move to the final step (phase V), a multicenter implementation across Canada to study actual impact. The investigators believe that teaching ED triage nurses to clear the c-spine of very low-risk trauma patients has the potential to significantly improve the efficiency and comfort of patient care in our busy Canadian EDs. Ultimately, the investigators expect the results of this study to be used by ED triage nurses throughout Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spine injury | Other | Other: Clinical decision rule - clearing the c-spineWe enrolled consecutive alert adults who were in stable condition and who presented with potential cervical spine injury after acute blunt trauma, including patients with posterior neck pain and those presenting by ambulance with immobilization of the cervical spine. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The investigators will enroll consecutive alert, stable adults presenting to the study hospital EDs with potential c-spine injury after sustaining acute blunt trauma. These will be patients presenting with neck pain or with c-spine immobilization on an ambulance stretcher. Patient eligibility will be determined based on these criteria at the time of arrival in the ED.
- "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck), and/or ii) presentation by ambulance with c-spine immobilization after injury (typically backboard and collar).
- "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands).
- "Stable" refers to normal vital signs as defined by the Revised Trauma Score31 (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 48 hours.
Key exclusion criteria (10 listed)
- Patients under the age of 16 years,
- Patients who do not satisfy the definition of "potential c-spine injury" as defined above (for example, patients with neither neck pain nor arriving with ambulance c-spine immobilization will be excluded),
- Patients with Glasgow Coma Scale score less than 15,
- Patients with unstable vital signs (systolic BP < 90; respiratory rate less than 10 or more than 24),
- Patients whose injury occurred more than 48 hours previously,
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 |
|---|---|---|
| Clinical decision rule - clearing the c-spineThe goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients. | Other | Cervical spine injury |
Primary outcome
Determine safety: Number of missed CSI & Number of serious adverse outcomes Determine clinical impact: C-spine clearance rates by nurses & Lengths of time
Time frame: Dec 2010
2 secondary outcomes
Evaluate performance: Accuracy of the rule, Nurse accuracy in overall interpretation of the rule & Nurse comfort with and use of the rule.
Time frame: Dec 2010
Evaluate performance
Time frame: December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
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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.
Ian G Stiell, 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 Phase 4 study testing Clinical decision rule - clearing the c-spine in people with Fracture of Cervical Spine and Fracture Dislocation 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 5 inclusion and 10 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 13 May 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine safety: Number of missed CSI & Number of serious adverse outcomes Determine clinical impact: C-spine clearance rates by nurses & Lengths of time (time frame: Dec 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2011.