Cervical Spine Clearance in Obtunded Trauma Patients

Completed

• Conditions: Coma; Wounds and Injuries
• Interventions: Other: Cervical Spine Clearance

• Registration Number: NCT00573014
• Lead Sponsor: MetroHealth Medical Center

Brief Summary

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.

Detailed Description

All OBTPs with gross movement of all four extremities admitted to MetroHealth Medical Center (MHMC), the regional Level I Trauma Center in Cleveland OH, who underwent a CT CS at MHMC between October 2006 and September 2008 will be included. Prospective data will be collected on these patients including age, gender, mechanism of injury, Glasgow Coma Scale (GCS) on admission, results of CT CS, GCS at the time of collar clearance, day of collar clearance, collar complications, date of reexamination, and results of reexamination. We will define an obtunded patient as a patient who was unable to reliably describe the presence or absence of CS symptoms in the opinion of the examining physician. Patients needed to have gross movement of all four extremities to be included in the study; if they did not, they were excluded. The presence or lack of sensory examination was not evaluated for the purposes of this study. We will define cervical collar complications as skin breakdown identified either by the skin care team during weekly rounds in the intensive care unit or by the treating physician at any time.

Study Timeline

• Study Start: 2006-10-01
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Primary Completion: 2008-07-01
• Study Completion: 2008-09-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OBTP	Cervical Spine Clearance	Obtunded blunt trauma patients with normal CT C-spine

Primary Outcome Measures

Name	Time	Method
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.	2 years	One hundred ninety-seven patients had their collars removed and CS cleared at a mean of 3.3 days. Removal of CS precautions in OBTPs with gross movement of all extremities is safe and efficacious if CT CS is negative for injury. Supplemental MRI CS is not needed in this patient population. Key Words: Magnetic resonance imaging, Computed tomography, Cervical

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States