Clinical trial NCT00783809: Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure
Official title: Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: intracranial pressure
intracranial hypertension
ultrasound
emergency
traumatic brain injury
ocular ultrasound
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2008-11-02
Enrollment: 560
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the emergency department with suspected closed head injury as a result of blunt trauma and require CT head

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Elevation in intracranial pressure as estimated by CT scan or ICP monitor
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Niv Sne, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Andrew J Healey, MD FRCPC
role: STUDY_CHAIR
References:
citation: Koziarz A, Sne N, Kegel F, Alhazzani W, Nath S, Badhiwala JH, Rice T, Engels P, Samir F, Healey A, Kahnamoui K, Banfield L, Sharma S, Reddy K, Hawryluk GWJ, Kirkpatrick AW, Almenawer SA. Optic nerve sheath diameter sonography for the diagnosis of increased intracranial pressure: a systematic review and meta-analysis protocol. BMJ Open. 2017 Aug 11;7(8):e016194. doi: 10.1136/bmjopen-2017-016194.