Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure (MOONSTRIP)
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Purpose
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.
| Condition |
|---|
|
Traumatic Brain Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure |
- Elevation in intracranial pressure as estimated by CT scan or ICP monitor [ Time Frame: Immediate ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients who present to the emergency department with suspected closed head injury as a result of blunt trauma and require CT head
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
Contacts and Locations| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L2X2 | |
| Principal Investigator: | Niv Sne, MD FRCSC | Hamilton Health Sciences Corporation |
| Study Chair: | Andrew J Healey, MD FRCPC | Hamilton Health Sciences Corporation |
More Information
No publications provided
| Responsible Party: | Niv Sne, Director of Trauma Research, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00783809 History of Changes |
| Other Study ID Numbers: | PSI-34-2008 |
| Study First Received: | October 31, 2008 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McMaster University:
|
intracranial pressure intracranial hypertension ultrasound |
emergency traumatic brain injury ocular ultrasound |
Additional relevant MeSH terms:
|
Intracranial Hypertension Brain Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013