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

NCT ID: NCT01278511

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Injury of Cervical Spine Cervical Spine Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Canadian C-Spine Rule

Group Type EXPERIMENTAL

Canadian C-Spine rule

Intervention Type OTHER

Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Pieter Jan Van Asbroeck

Dr. Pieter Jan Van Asbroeck

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koen Bronselaer, MD, PhD

Role: STUDY_DIRECTOR

Emergency Department of the University Hospitals, Catholic University Leuven

Marc Sabbe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emergency Department of the University Hospitals, Catholic University Leuven

Pieter Jan Van Asbroeck, Drs

Role: PRINCIPAL_INVESTIGATOR

Emergency Department of the University Hospitals, Catholic University Leuven

Locations

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Emergency Department of the University Hospitals, Catholic University Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S52940

Identifier Type: -

Identifier Source: org_study_id

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