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      Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial

      , MD, MSc 1 , 2 , , , MSc 2 , , PhD 2 , , BPharm, MPharm, PhD 2 , , BSc 3 , , MPH/MHM, ACP 4 , , MHA, PhD 2 , , PhD 2 , , MA, PhD, FCAHS 2 , , MD, MSc 5 , , PhD 2 , , O.C., MD 2 , , ACP 6 , , MD 7 , , MSc 8 , , MD, MSc 9 , , MD 9 , , MBChB, PhD 10 , , MD, MSc 11 , , MD, MPH 12 , , MD, MSc 13 , , PhD 14 , , MSc 15 , , MD, MSc 1 , 2
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      cervical spine injury, Canadian C-Spine rule, immobilization, paramedic, trauma

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          Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study.


          This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED.


          We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study.


          Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario.


          We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year).

          Trial Registration

          ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966.

          International Registered Report Identifier (IRRID)


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          Most cited references10

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          The Canadian C-spine rule versus the NEXUS low-risk criteria in patients with trauma.

          The Canadian C-Spine (cervical-spine) Rule (CCR) and the National Emergency X-Radiography Utilization Study (NEXUS) Low-Risk Criteria (NLC) are decision rules to guide the use of cervical-spine radiography in patients with trauma. It is unclear how the two decision rules compare in terms of clinical performance. We conducted a prospective cohort study in nine Canadian emergency departments comparing the CCR and NLC as applied to alert patients with trauma who were in stable condition. The CCR and NLC were interpreted by 394 physicians for patients before radiography. Among the 8283 patients, 169 (2.0 percent) had clinically important cervical-spine injuries. In 845 (10.2 percent) of the patients, physicians did not evaluate range of motion as required by the CCR algorithm. In analyses that excluded these indeterminate cases, the CCR was more sensitive than the NLC (99.4 percent vs. 90.7 percent, P<0.001) and more specific (45.1 percent vs. 36.8 percent, P<0.001) for injury, and its use would have resulted in lower radiography rates (55.9 percent vs. 66.6 percent, P<0.001). In secondary analyses that included all patients, the sensitivity and specificity of CCR, assuming that the indeterminate cases were all positive, were 99.4 percent and 40.4 percent, respectively (P<0.001 for both comparisons with the NLC). Assuming that the CCR was negative for all indeterminate cases, these rates were 95.3 percent (P=0.09 for the comparison with the NLC) and 50.7 percent (P=0.001). The CCR would have missed 1 patient and the NLC would have missed 16 patients with important injuries. For alert patients with trauma who are in stable condition, the CCR is superior to the NLC with respect to sensitivity and specificity for cervical-spine injury, and its use would result in reduced rates of radiography. Copyright 2003 Massachusetts Medical Society
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            Prehospital use of cervical collars in trauma patients: a critical review.

            The cervical collar has been routinely used for trauma patients for more than 30 years and is a hallmark of state-of-the-art prehospital trauma care. However, the existing evidence for this practice is limited: Randomized, controlled trials are largely missing, and there are uncertain effects on mortality, neurological injury, and spinal stability. Even more concerning, there is a growing body of evidence and opinion against the use of collars. It has been argued that collars cause more harm than good, and that we should simply stop using them. In this critical review, we discuss the pros and cons of collar use in trauma patients and reflect on how we can move our clinical practice forward. Conclusively, we propose a safe, effective strategy for prehospital spinal immobilization that does not include routine use of collars.
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              A prospective multicenter study of cervical spine injury in children.

              Pediatric victims of blunt trauma have developmental and anatomic characteristics that can make it difficult to assess their risk of cervical spine injury (CSI). Previous reports, all retrospective in nature, have not identified any cases of CSI in either children or adults in the absence of neck pain, neurologic symptoms, distracting injury, or altered mental status. The objective of this study was to examine the incidence and spectrum of spine injury in patients who are younger than 18 years and to evaluate the efficacy of the National Emergency X-Radiography Utilization Study (NEXUS) decision instrument for obtaining cervical spine radiography in pediatric trauma victims. We performed a prospective, multicenter study to evaluate pediatric blunt trauma victims. All patients who presented to participating emergency departments underwent clinical evaluation before radiographic imaging. The presence or absence of the following criteria was noted: midline cervical tenderness, altered level of alertness, evidence of intoxication, neurologic abnormality, and presence of painful distracting injury. Presence or absence of each individual criterion was documented for each patient before radiographic imaging, unless the patient was judged to be too unstable to complete the clinical evaluation before radiographs. The decision to radiograph a patient was entirely at the physician's discretion and not driven by the NEXUS questionnaire. The presence or absence of CSI was based on the final interpretation of all radiographic studies. Data on all patients who were younger than 18 years were sequestered from the main database for separate analysis. There were 3065 patients (9.0% of all NEXUS patients) who were younger than 18 years in this cohort, 30 of whom (0.98%) sustained a CSI. Included in the study were 88 children who were younger than 2, 817 who were between 2 and 8, and 2160 who were 8 to 17. Fractures of the lower cervical vertebrae (C5-C7) accounted for 45.9% of pediatric CSIs. No case of spinal cord injury without radiographic abnormality was reported in any child in this study, although 22 cases were reported in adults. Only 4 of the 30 injured children were younger than 9 years, and none was younger than 2 years. Tenderness and distracting injury were the 2 most common abnormalities noted in patients with and without CSI. The decision rule correctly identified all pediatric CSI victims (sensitivity: 100.0%; 95% confidence interval: 87.8%-100.0%) and correctly designated 603 patients as low risk for CSI (negative predictive value: 100.0%; 95% confidence interval: 99.4%-100.0%). The lower cervical spine is the most common site of CSI in children, and fractures are the most common type of injury. CSI is rare among patients aged 8 years or younger. The NEXUS decision instrument performed well in children, and its use could reduce pediatric cervical spine imaging by nearly 20%. However, the small number of infants and toddlers in the study suggests caution in applying the NEXUS criteria to this particular age group.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                June 2020
                1 June 2020
                : 9
                : 6
                : e16966
                [1 ] Department of Emergency Medicine Ottawa Hospital Research Institute University of Ottawa Ottawa, ON Canada
                [2 ] Ottawa Hospital Research Institute Ottawa, ON Canada
                [3 ] Patient Representative Owner-Hall Consulting Director-Helping Hands for India Kanata, ON Canada
                [4 ] Paramedic Representative Hamilton Paramedic Service Hamilton, ON Canada
                [5 ] Medical Care Analytics Canadian Medical Protective Association Ottawa, ON Canada
                [6 ] Ottawa Paramedic Service Ottawa, ON Canada
                [7 ] Department of Family and Community Medicine Division of Emergency Medicine University of Toronto Toronto, ON Canada
                [8 ] Institute for Clinical Evaluative Sciences Toronto, ON Canada
                [9 ] Children’s Hospital of Eastern Ontario Research Institute Ottawa, ON Canada
                [10 ] Clinical Research Services, SickKids Toronto, ON Canada
                [11 ] Knowledge Translation Program St. Michael’s Hospital Toronto, ON Canada
                [12 ] Women’s College Research Institute Toronto, ON Canada
                [13 ] Institut de recherche de l’Hôpital Montfort Ottawa, ON Canada
                [14 ] Élisabeth Bruyère Research Institute Ottawa, ON Canada
                [15 ] Clinical Trials Ontario Toronto, ON Canada
                Author notes
                Corresponding Author: Christian Vaillancourt cvaillancourt@ 123456ohri.ca
                Author information
                ©Christian Vaillancourt, Manya Charette, Monica Taljaard, Kednapa Thavorn, Elizabeth Hall, Brent McLeod, Dean Fergusson, Jamie Brehaut, Ian Graham, Lisa Calder, Tim Ramsay, Peter Tugwell, Peter Kelly, Sheldon Cheskes, Refik Saskin, Amy Plint, Martin Osmond, Colin Macarthur, Sharon Straus, Paula Rochon, Denis Prud'homme, Simone Dahrouge, Susan Marlin, Ian G Stiell. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.06.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 7 November 2019
                : 11 December 2019
                : 23 December 2019
                : 31 December 2019

                cervical spine injury,canadian c-spine rule,immobilization,paramedic,trauma


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