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Cervical Spine Clearance in Obtunded Trauma Patients (CSclearance)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00573014
First received: December 10, 2007
Last updated: August 29, 2017
Last verified: August 2017
  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 Other: 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 ]
    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


Enrollment: 197
Actual Study Start Date: October 1, 2006
Study Completion Date: September 30, 2008
Primary Completion Date: July 1, 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OBTP
Obtunded blunt trauma patients with normal CT C-spine
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.

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00573014

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

Responsible Party: MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00573014     History of Changes
Other Study ID Numbers: IRB04-00110
Study First Received: December 10, 2007
Last Updated: August 29, 2017

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 September 19, 2017