Cervical Spine Clearance in Obtunded Trauma Patients (CSclearance)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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.
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| Contact: John J Como, MD | 216-778-1005 | jcomo@metrohealth.org |
| United States, Ohio | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| 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 May 23, 2013