Back to resultsProspective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
Primary Purpose
Injury of Cervical Spine, Cervical Spine Fractures
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Canadian C-Spine rule
Sponsored by
About this trial
This is an interventional diagnostic trial for Injury of Cervical Spine focused on measuring Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates
Eligibility Criteria
Inclusion Criteria:
- Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
- Alert: GCS ≥ 14
Stable:
- systolic blood pressure ≥ 90 mmHg
- respiratory frequency 12 - 20 / min
- adult ≥ 18 years old
- Acute: ≤ 4
Possible injury to the cervical spine:
- posterior neck pain following any mechanism
- no neck pain but visible injury above the clavicles
- no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury
Exclusion Criteria:
- Acute paralysis (quadriplegia, paraplegia)
- Penetrating trauma to the neck
- Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
- Pregnancy
Sites / Locations
- Emergency Department of the University Hospitals, Catholic University Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Canadian C-Spine Rule
Arm Description
Outcomes
Primary Outcome Measures
Missed cervical spine injuries and fractures
Secondary Outcome Measures
Performance of the Canadian c-spine rule
Performance includes rule accuracy
Level of comfort
Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01278511
Brief Title
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
Official Title
A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Not feasible
Study Start Date
January 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Cervical Spine, Cervical Spine Fractures
Keywords
Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canadian C-Spine Rule
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Canadian C-Spine rule
Intervention Description
Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.
Primary Outcome Measure Information:
Title
Missed cervical spine injuries and fractures
Time Frame
At the first visit to the emergency department until 30 days after inclusion
Secondary Outcome Measure Information:
Title
Performance of the Canadian c-spine rule
Description
Performance includes rule accuracy
Time Frame
Analyzed at the end of the pilot study in april 2011
Title
Level of comfort
Description
Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol
Time Frame
Analyzed at the end of the pilot study in april 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
Alert: GCS ≥ 14
Stable:
systolic blood pressure ≥ 90 mmHg
respiratory frequency 12 - 20 / min
adult ≥ 18 years old
Acute: ≤ 4
Possible injury to the cervical spine:
posterior neck pain following any mechanism
no neck pain but visible injury above the clavicles
no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury
Exclusion Criteria:
Acute paralysis (quadriplegia, paraplegia)
Penetrating trauma to the neck
Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Bronselaer, MD, PhD
Organizational Affiliation
Emergency Department of the University Hospitals, Catholic University Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marc Sabbe, MD, PhD
Organizational Affiliation
Emergency Department of the University Hospitals, Catholic University Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pieter Jan Van Asbroeck, Drs
Organizational Affiliation
Emergency Department of the University Hospitals, Catholic University Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department of the University Hospitals, Catholic University Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
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