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Cervical Spine Clearance in Obtunded Trauma Patients (CSclearance)

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ClinicalTrials.gov Identifier: NCT00573014
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
MetroHealth Medical Center

December 10, 2007
December 13, 2007
August 30, 2017
October 1, 2006
July 1, 2008   (Final data collection date for primary outcome 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. [ Time Frame: 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
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 ]
Complete list of historical versions of study NCT00573014 on ClinicalTrials.gov Archive Site
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Cervical Spine Clearance in Obtunded Trauma Patients
Evaluating the Need for Magnetic Resonance Imaging of the Cervical Spine in Obtunded Trauma Patients
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.
  • Coma
  • Wounds and Injuries
Other: Cervical Spine Clearance
All OBTPs with gross movement of all four extremities admitted to MetroHealth Medical Center 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. We defined 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.
OBTP
Obtunded blunt trauma patients with normal CT C-spine
Intervention: Other: Cervical Spine Clearance
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
200
September 30, 2008
July 1, 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00573014
IRB04-00110
IRB04-00110
No
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MetroHealth Medical Center
MetroHealth Medical Center
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Principal Investigator: John J Como, MD MetroHealth Medical Center
MetroHealth Medical Center
August 2017