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

Injury of Cervical Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01278511
• Other study ID #: S52940
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2011
• Last updated: January 26, 2016
• Start date: January 2011

Study information

• Verified date: January 2016
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Spine Fractures
• Injury of Cervical Spine
• Spinal Fractures

Intervention

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.

Locations

Country	Name	City	State
Belgium	Emergency Department of the University Hospitals, Catholic University Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Missed cervical spine injuries and fractures		At the first visit to the emergency department until 30 days after inclusion
Secondary	Performance of the Canadian c-spine rule	Performance includes rule accuracy	Analyzed at the end of the pilot study in april 2011
Secondary	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	Analyzed at the end of the pilot study in april 2011