ComaCSclearanceNCT00573014
Cervical Spine Clearance in Obtunded Trauma Patients
An observational study of Coma and Wounds and Injuries, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coma, Wounds and Injuries
- What is being tested?
- Cervical Spine Clearance
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2006to 30 Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coma, Wounds and Injuries
- Being tested
- Cervical Spine Clearance
- Keywords
- Obtunded blunt trauma patients
- Medical subject headings
- Coma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Spine ClearanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OBTP | Obtunded blunt trauma patients with normal CT C-spine Receives: Other: Cervical Spine Clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study start1 Oct 2006
- Primary completion1 Jul 2008
- Study completion30 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J Como, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573014
- Sponsor's protocol ID
- IRB04-00110
- Other IDs
- IRB04-00110
- Acronym
- CSclearance
- Status last verified
- Aug 2017
- First submitted
- 10 Dec 2007
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Need for Magnetic Resonance Imaging of the Cervical Spine in Obtunded Trauma Patients
- ClinicalTrials.gov ID
- NCT00573014
- Acronym / sponsor ID
- CSclearance / IRB04-00110
- Conditions
- Coma, Wounds and Injuries
- Keywords
- Obtunded blunt trauma patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 1 Jul 2008 (actual)
- Study completion
- 30 Sep 2008 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBTP | – | Other: Cervical Spine ClearanceObtunded blunt trauma patients with normal CT C-spine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Spine ClearanceAll 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. | Other | OBTP |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Como, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma and Wounds and Injuries, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.