Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02786966
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics
Sponsor:
Organization:
Raw JSON
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Values \\>=5 were considered to indicate discomfort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients With a Pain Score </= 5/10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1423', 'groupId': 'OG000'}, {'value': '1333', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Phase (Usual Care)', 'description': 'Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).'}, {'id': 'OG001', 'title': 'Canadian C-Spine Rule', 'description': 'Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.'}], 'classes': [{'categories': [{'measurements': [{'value': '866', 'groupId': 'OG000'}, {'value': '736', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and sex'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study completion', 'description': 'Measured on a 10-point ordinal scale with increasing values indicating greater pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to Hospital', 'timeFrame': 'At time of initial injury', 'description': 'Time from paramedic arrival at patient side to ED discharge or admission to hospital', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Radiation Exposure', 'timeFrame': '30 days from initial injury', 'description': 'radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Skin Pressure Injuries', 'timeFrame': 'through study completion (one year)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Missed Cervical Spine Injuries', 'timeFrame': 'through study completion (one year)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital)', 'timeFrame': 'at time of initial injury', 'description': 'arrival at patient side until departure for hospital', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Paramedic Hospital Time', 'timeFrame': 'through study completion (one year)', 'description': 'from arrival at emergency department to transfer of care to emergency department staff', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subsequent Emergency Department Visits or Hospital Admissions', 'timeFrame': 'through study completion (one year)', 'description': 'within 30 days of initial visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subsequent Clinic or Family Physician Visits', 'timeFrame': 'within 30 days of initial injury', 'description': 'within 30 days of initial visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Cervical Spine Diagnostic Imaging', 'timeFrame': 'within 30 days of initial injury', 'description': 'at initial visit or within 30 days of initial visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost Savings', 'timeFrame': 'through study completion (one year)', 'description': 'incremental cost saving per one immobilization avoided', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: Usual Care Months 1-3, Canadian C-Spine Rule Months 4-9', 'description': '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.'}, {'id': 'FG001', 'title': 'Sequence 2: Usual Care Months 1-6, Canadian C-Spine Rule Months 7-9', 'description': '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.'}, {'id': 'FG002', 'title': 'Sequence 3: Usual Care Months 1-9', 'description': '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.'}], 'periods': [{'title': 'Step 1: Months 1-3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '351'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '285'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '351'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '285'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Step 2: Months 4-6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '758'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '471'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '758'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '468'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '3'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Step 3: Months 7-9', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '552'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '591'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '552'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '589'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '224'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '2'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Paramedic Services'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1745', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3646', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Phase (Usual Care)', 'description': 'Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).'}, {'id': 'BG001', 'title': 'Canadian C-Spine Rule', 'description': 'Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1745', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3646', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '21.9', 'groupId': 'BG000'}, {'value': '46.5', 'spread': '21.9', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '21.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1745', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3646', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '876', 'groupId': 'BG000'}, {'value': '998', 'groupId': 'BG001'}, {'value': '1874', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '869', 'groupId': 'BG000'}, {'value': '903', 'groupId': 'BG001'}, {'value': '1772', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1745', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3646', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1745', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3646', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Ontario Canada', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-01', 'size': 4299605, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-31T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3646}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2016-05-18', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-29', 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of Patients With a Pain Score </= 5/10', 'timeFrame': 'At study completion', 'description': 'Measured on a 10-point ordinal scale with increasing values indicating greater pain.'}, {'measure': 'Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to Hospital', 'timeFrame': 'At time of initial injury', 'description': 'Time from paramedic arrival at patient side to ED discharge or admission to hospital'}, {'measure': 'Radiation Exposure', 'timeFrame': '30 days from initial injury', 'description': 'radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit'}, {'measure': 'Number of Skin Pressure Injuries', 'timeFrame': 'through study completion (one year)'}, {'measure': 'Number of Missed Cervical Spine Injuries', 'timeFrame': 'through study completion (one year)'}, {'measure': 'Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital)', 'timeFrame': 'at time of initial injury', 'description': 'arrival at patient side until departure for hospital'}, {'measure': 'Paramedic Hospital Time', 'timeFrame': 'through study completion (one year)', 'description': 'from arrival at emergency department to transfer of care to emergency department staff'}, {'measure': 'Subsequent Emergency Department Visits or Hospital Admissions', 'timeFrame': 'through study completion (one year)', 'description': 'within 30 days of initial visit'}, {'measure': 'Subsequent Clinic or Family Physician Visits', 'timeFrame': 'within 30 days of initial injury', 'description': 'within 30 days of initial visit'}, {'measure': 'Frequency of Cervical Spine Diagnostic Imaging', 'timeFrame': 'within 30 days of initial injury', 'description': 'at initial visit or within 30 days of initial visit'}, {'measure': 'Cost Savings', 'timeFrame': 'through study completion (one year)', 'description': 'incremental cost saving per one immobilization avoided'}], 'primaryOutcomes': [{'measure': 'Proportion of Patients Transported With Spinal Immobilization', 'timeFrame': 'Through study completion.'}, {'measure': 'Proportion of Patients Feeling Uncomfortable', 'timeFrame': 'At study completion', 'description': 'Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values \\>=5 were considered to indicate discomfort.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical spine injuries', 'Canadian C-spine Rule', 'Emergency Medical Services', 'Paramedic', 'Cervical spine fracture'], 'conditions': ['Neck Injuries']}, 'referencesModule': {'references': [{'pmid': '32348267', 'type': 'RESULT', 'citation': "Vaillancourt C, Charette M, Taljaard M, Thavorn K, Hall E, McLeod B, Fergusson D, Brehaut J, Graham I, Calder L, Ramsay T, Tugwell P, Kelly P, Cheskes S, Saskin R, Plint A, Osmond M, Macarthur C, Straus S, Rochon P, Prud'homme D, Dahrouge S, Marlin S, Stiell IG. 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. JMIR Res Protoc. 2020 Jun 1;9(6):e16966. doi: 10.2196/16966."}]}, 'descriptionModule': {'briefSummary': 'Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly.\n\nThe investigators 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.\n\nThe investigators will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested the investigators include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. The investigators will also measure the impact on the ED, and how much money could be saved if more paramedics were allowed to use the CCR. The investigators will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.', 'detailedDescription': 'Paramedics in participating Ontario communities will all receive standardized training on the application of the Canadian C-Spine Rule (CCR). Once the training has been completed, paramedics will begin using the CCR to evaluate patients with potential c-spine injuries. For the first three months of the evaluation period, paramedics will use the CCR to evaluate eligible patients, but continue to use spinal immobilization for transport according to their existing protocols. After this validation period, participating services will be randomized in stepped wedge fashion in clusters of 4 services to actively use the CCR and selectively immobilize according to the CCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alert (Glasgow Coma Scale 15)\n* Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute\n* Acute blunt injury (within 48 hours of paramedic contact)\n\nExclusion Criteria:\n\n* Age \\<8 years of age\n* Penetrating trauma from stabbing or gunshot wound\n* Acute paralysis (paraplegia, quadriplegia)\n* Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)\n* Referred from another hospital'}, 'identificationModule': {'nctId': 'NCT02786966', 'briefTitle': 'A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization', 'orgStudyIdInfo': {'id': 'CTO 0769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Phase', 'description': 'Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).', 'interventionNames': ['Other: Canadian C-Spine Rule']}], 'interventions': [{'name': 'Canadian C-Spine Rule', 'type': 'OTHER', 'description': 'Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule', 'armGroupLabels': ['Control Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Christian Vaillancourt, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Insitute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ontario Spor Support Unit', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}