Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital

January 26, 2016 updated by: Pieter Jan Van Asbroeck, KU Leuven

A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Emergency Department of the University Hospitals, Catholic University Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canadian C-Spine Rule
Other: Canadian C-Spine rule
Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Missed cervical spine injuries and fractures
Time Frame: At the first visit to the emergency department until 30 days after inclusion
At the first visit to the emergency department until 30 days after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the Canadian c-spine rule
Time Frame: Analyzed at the end of the pilot study in april 2011
Performance includes rule accuracy
Analyzed at the end of the pilot study in april 2011
Level of comfort
Time Frame: Analyzed at the end of the pilot study in april 2011
Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol
Analyzed at the end of the pilot study in april 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Study Director: Koen Bronselaer, MD, PhD, Emergency Department of the University Hospitals, Catholic University Leuven
  • Principal Investigator: Marc Sabbe, MD, PhD, Emergency Department of the University Hospitals, Catholic University Leuven
  • Principal Investigator: Pieter Jan Van Asbroeck, Drs, Emergency Department of the University Hospitals, Catholic University Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S52940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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