Clinical trial NCT00573014: Cervical Spine Clearance in Obtunded Trauma Patients
Official title: Evaluating the Need for Magnetic Resonance Imaging of the Cervical Spine in Obtunded Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coma
Wounds and Injuries
Keywords: Obtunded blunt trauma patients
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: John J Como, MD
role: PRINCIPAL_INVESTIGATOR
References: