Cervical Spine Clearance in Obtunded Trauma Patients (CSclearance)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by MetroHealth Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00573014
First received: December 10, 2007
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

The optimal method of clearing the cervical spine in obtunded trauma patients is unclear. Computed tomography (CT) identifies most injuries but may miss ligamentous injuries. Magnetic resonance (MR) imaging has been widely used to exclude ligamentous injuries. We postulate that with the new generation of CT scanners, MR imaging is not needed to rule out significant injuries. Our protocol for clearing the cervical spine in obtunded trauma patients depends on CT alone. We are prospectively following these patients and performing a clinical examination when they are awake to show this is a safe approach.


Condition Intervention
Coma
Wounds and Injuries
Procedure: Cervical spine clearance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Need for Magnetic Resonance Imaging of the Cervical Spine in Obtunded Trauma Patients

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • We postulate that with the new generation of CT scanners, MR imaging is not needed to rule out significant injuries. We hope to show that CT alone can be used to clear the cervical spine in obtunded trauma patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2006
Estimated Study Completion Date: September 2008
Groups/Cohorts Assigned Interventions
OBTP
Obtunded blunt trauma patients with normal CT C-spine
Procedure: Cervical spine clearance
Cervical spine clearance

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will include all patients (including children) after blunt trauma in whom cervical spine injury has not been ruled out admitted to MetroHealth Medical Center from 10/1/2004-9/30/2006. We are excluding patients with an obvious neurologic deficit attributable to the cervical spine. We are excluding patients with abnormalities of the cervical spine that are identified on either plain films or CT. We are also excluding those patients in whom the cervical spine can be cleared clinically due to normal mental status.

Criteria

Inclusion Criteria:

  • Subjects will include all patients (including children) after blunt trauma in whom cervical spine injury has not been ruled out admitted to MetroHealth Medical Center from 10/1/2004-9/30/2006.

Exclusion Criteria:

  • We are excluding patients with an obvious neurologic deficit attributable to the cervical spine.
  • We are excluding patients with abnormalities of the cervical spine that are identified on either plain films or CT.
  • We are also excluding those patients in whom the cervical spine can be cleared clinically due to normal mental status.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573014

Contacts
Contact: John J Como, MD 216-778-1005 jcomo@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: John J Como, MD MetroHealth Medical Center
  More Information

No publications provided

Responsible Party: John J. Como, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00573014     History of Changes
Other Study ID Numbers: IRB04-00110, IRB04-00110
Study First Received: December 10, 2007
Last Updated: December 12, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
Obtunded blunt trauma patients

Additional relevant MeSH terms:
Wounds and Injuries
Stupor
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014