- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783809
Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure (MOONSTRIP)
Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner.
The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this.
The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure.
**Update August 2009** Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8L2X2
- Hamilton General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater or equal to 16 involved in blunt trauma.
- Patient is to undergo a CT of the head to evaluate suspected closed head injury
- Consent and ultrasound can be preformed within 1 hour before or after CT of the head
Exclusion Criteria:
- Penetrating trauma to the head or significant ocular trauma
- Patients not expected to survive transfer out of the emergency room department
- Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Elevation in intracranial pressure as estimated by CT scan or ICP monitor
Time Frame: Immediate
|
Immediate
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Niv Sne, MD FRCSC, Hamilton Health Sciences Corporation
- Study Chair: Andrew J Healey, MD FRCPC, Hamilton Health Sciences Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSI-34-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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